Trial Outcomes & Findings for A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors (NCT NCT04577963)
NCT ID: NCT04577963
Last Updated: 2025-07-14
Results Overview
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting \>7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for \<72 hours with antiemetic and supportive care, G 3 fatigue for \<1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)
Results posted on
2025-07-14
Participant Flow
This phase 1b/2, 2-part, open-label study was conducted in patients with advanced or metastatic solid tumors.
The study consisted of a safety lead-in phase (Part 1) and a dose expansion phase (Part 2). A total of 52 patients were enrolled in this study (6 patients received study treatment in Part 1 and 46 patients received study treatment in Part 2). The study was terminated early based upon the strategic evaluation of clinical development of fruquintinib in the United States. This change was not based on any concern for patient safety or efficacy relative to fruquintinib and/or tislelizumab treatment.
Participant milestones
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either immuno-oncology (IO)-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 milligrams (mg) orally once daily (QD) for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg intravenous (IV) infusion once every 4 weeks (Q4W) until radiologically determined progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
Patients with advanced or metastatic triple negative breast cancer (TNBC) including those with estrogen receptor (ER) or progesterone receptor (PGR) low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an immune checkpoint inhibitor (ICI) or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
Patients with advanced or metastatic endometrial cancer (EC) who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic (m) microsatellite stable (MSS) colorectal cancer (CRC) who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-vascular endothelial growth factor (VEGF) (if rat sarcoma \[RAS\]: wild-type tumor, mutated or status unknown) or endothelial growth factor receptor (EGFR) (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 1
STARTED
|
6
|
0
|
0
|
0
|
0
|
|
Part 1
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
0
|
1
|
11
|
1
|
39
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
1
|
11
|
1
|
39
|
Reasons for withdrawal
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either immuno-oncology (IO)-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 milligrams (mg) orally once daily (QD) for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg intravenous (IV) infusion once every 4 weeks (Q4W) until radiologically determined progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
Patients with advanced or metastatic triple negative breast cancer (TNBC) including those with estrogen receptor (ER) or progesterone receptor (PGR) low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an immune checkpoint inhibitor (ICI) or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
Patients with advanced or metastatic endometrial cancer (EC) who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic (m) microsatellite stable (MSS) colorectal cancer (CRC) who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-vascular endothelial growth factor (VEGF) (if rat sarcoma \[RAS\]: wild-type tumor, mutated or status unknown) or endothelial growth factor receptor (EGFR) (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 2
Death
|
0
|
1
|
8
|
0
|
20
|
|
Part 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
2
|
|
Part 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
10
|
|
Part 2
Progressive disease
|
0
|
0
|
0
|
0
|
2
|
|
Part 2
Investigator decision
|
0
|
0
|
0
|
0
|
1
|
|
Part 2
Sponsor terminated study
|
0
|
0
|
3
|
1
|
4
|
Baseline Characteristics
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
n=1 Participants
Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=11 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=1 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)Population: The DLT-evaluable analysis set included all patients enrolled in Part 1 of the study who received at least 1 dose of fruquintinib or tislelizumab and were considered DLT-evaluable based on the safety review committee review, according to the pre-specified criteria from the protocol.
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting \>7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for \<72 hours with antiemetic and supportive care, G 3 fatigue for \<1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs)
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)Population: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The RP2D of fruquintinib in combination with tislelizumab based on the safety and tolerability assessments in Part 1 patients.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 1: Recommended Phase 2 Dose (RP2D) of Fruquintinib in Combination With Tislelizumab
|
5 mg
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=11 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=1 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 2: Objective Response Rate (ORR)
|
0 percentage of patients
NA indicates that upper and lower limits of confidence interval (CI) were not estimable as there were no patients with CR or PR in that disease cohort.
|
27.3 percentage of patients
Interval 6.0 to 61.0
|
0 percentage of patients
NA indicates that upper and lower limits of confidence interval (CI) were not estimable as there were no patients with CR or PR in that disease cohort.
|
5.1 percentage of patients
Interval 0.6 to 17.3
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 1: Objective Response Rate
|
16.7 percentage of patients
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=11 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Progression-free Survival (PFS)
|
3.8 months
Interval 1.8 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
5.0 months
Interval 1.8 to 7.4
|
5.5 months
NA indicates that upper and lower limits of CI were not estimable for only 1 patient.
|
3.6 months
Interval 2.0 to 5.6
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=11 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Disease Control Rate (DCR)
|
50.0 percentage of patients
Interval 11.8 to 88.2
|
0 percentage of patients
NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD for at least 7 weeks.
|
72.7 percentage of patients
Interval 39.0 to 94.0
|
100 percentage of patients
Interval 2.5 to 100.0
|
53.8 percentage of patients
Interval 37.2 to 69.9
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD (i.e., lasting for at least 6 months) as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=11 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Clinical Benefit Rate (CBR)
|
16.7 percentage of patients
Interval 0.4 to 64.1
|
0 percentage of patients
NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
|
27.3 percentage of patients
Interval 6.0 to 61.0
|
0 percentage of patients
NA indicates that upper and lower limits of CI were not estimable due to no patients with CR, PR, or SD lasting for at least 6 months.
|
20.5 percentage of patients
Interval 9.3 to 36.5
|
SECONDARY outcome
Timeframe: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Only those patients with PR or CR (responders) were included in the analysis.
The DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, whichever came first until PD or death. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=3 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=2 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Duration of Response (DoR)
|
14.9 months
NA indicates that upper and lower limits of CI were not estimable for only 1 patient.
|
—
|
14.9 months
Interval 6.0 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
—
|
NA months
NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
SECONDARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to date of death due to any cause, up to a maximum of approximately 34 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
The OS was defined as the time from start of study treatment until the date of death due to any cause.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=11 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Overall Survival (OS)
|
16.4 months
Interval 12.0 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
25.8 months
NA indicates that upper and lower limits of CI were not estimable for only 1 patient.
|
14.1 months
Interval 5.0 to
NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
|
NA months
NA indicates that median, upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
|
10.2 months
Interval 7.1 to 11.7
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1, 8, 15, 21 of Cycle 1 and on Day 1 of Cycles 2, 4, 7, 13; 2 to 4 hours post-dose on Days 1 and 21 of Cycle 1 (cycle duration: 4 weeks)Population: The pharmacokinetic (PK) analysis set included all patients with at least 1 quantifiable plasma or serum concentration of fruquintinib and/or tislelizumab. Only unique patients in Parts 1 and 2 were considered for PK analysis. Cohort A did not enroll any unique patients in Part 2. Only patients who had a quantifiable plasma/serum concentration of fruquintinib at specified timepoints are reported.
Blood samples were collected at the specified timepoints to determine plasma concentrations of fruquintinib and metabolite M11.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=6 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=37 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 1: Pre-dose
|
0 nanograms per milliliter
Standard Deviation 0
|
—
|
0 nanograms per milliliter
Standard Deviation 0
|
0 nanograms per milliliter
Standard Deviation 0
|
0 nanograms per milliliter
Standard Deviation 0
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 2 Day 1: Pre-dose
|
—
|
—
|
23.2 nanograms per milliliter
Standard Deviation 15.3
|
15.2 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
17.0 nanograms per milliliter
Standard Deviation 17.7
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 4 Day 1: Pre-dose
|
—
|
—
|
5.12 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
15.3 nanograms per milliliter
Standard Deviation 8.89
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 7 Day 1: Pre-dose
|
—
|
—
|
—
|
—
|
28.6 nanograms per milliliter
Standard Deviation 19.1
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 13 Day 1: Pre-dose
|
—
|
—
|
—
|
—
|
12.3 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 1: Pre-dose
|
0 nanograms per milliliter
Standard Deviation 0
|
—
|
0 nanograms per milliliter
Standard Deviation 0
|
0 nanograms per milliliter
Standard Deviation 0
|
0 nanograms per milliliter
Standard Deviation 0
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 1: 2 to 4 hours post-dose
|
0 nanograms per milliliter
Standard Deviation 0
|
—
|
0.415 nanograms per milliliter
Standard Deviation 0.643
|
2.71 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
0.413 nanograms per milliliter
Standard Deviation 0.766
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 8: Pre-dose
|
—
|
—
|
84.2 nanograms per milliliter
Standard Deviation 53.5
|
—
|
60.7 nanograms per milliliter
Standard Deviation 34.7
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 15: Pre-dose
|
—
|
—
|
87.3 nanograms per milliliter
Standard Deviation 32.4
|
139 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
74.6 nanograms per milliliter
Standard Deviation 45.9
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 21: Pre-dose
|
148 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
106 nanograms per milliliter
Standard Deviation 40.0
|
—
|
66.1 nanograms per milliliter
Standard Deviation 28.0
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 1 Day 21: 2 to 4 hours post-dose
|
124 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
124 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
69.1 nanograms per milliliter
Standard Deviation 25.4
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 2 Day 1: Pre-dose
|
—
|
—
|
30.8 nanograms per milliliter
Standard Deviation 12.6
|
40.5 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
20.5 nanograms per milliliter
Standard Deviation 14.4
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 4 Day 1: Pre-dose
|
—
|
—
|
16.6 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
19.3 nanograms per milliliter
Standard Deviation 10.4
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 7 Day 1: Pre-dose
|
—
|
—
|
—
|
—
|
31.4 nanograms per milliliter
Standard Deviation 8.60
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
M11: Cycle 13 Day 1: Pre-dose
|
—
|
—
|
—
|
—
|
11.7 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 1: 2 to 4 hours post-dose
|
5.49 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
56.2 nanograms per milliliter
Standard Deviation 52.9
|
125 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
70.7 nanograms per milliliter
Standard Deviation 34.3
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 8: Pre-dose
|
—
|
—
|
222 nanograms per milliliter
Standard Deviation 29.0
|
—
|
195 nanograms per milliliter
Standard Deviation 57.0
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 15: Pre-dose
|
—
|
—
|
240 nanograms per milliliter
Standard Deviation 72.7
|
263 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
177 nanograms per milliliter
Standard Deviation 37.7
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 21: Pre-dose
|
252 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
216 nanograms per milliliter
Standard Deviation 59.5
|
—
|
186 nanograms per milliliter
Standard Deviation 51.4
|
|
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Fruquintinib: Cycle 1 Day 21: 2 to 4 hours post-dose
|
327 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
327 nanograms per milliliter
Standard Deviation NA
NA indicates that standard deviation (SD) was not estimable for 1 patient.
|
—
|
267 nanograms per milliliter
Standard Deviation 66.4
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1 of Cycles 1, 2, 4, 7, 13; at end of infusion on Day 1 of Cycles 1 and 4; on Days 8, 15, and 21 of Cycle 1 (cycle duration: 4 weeks)Population: The PK analysis set included all patients with at least 1 quantifiable plasma or serum concentration of fruquintinib and/or tislelizumab. Only unique patients in Parts 1 and 2 were considered for PK analysis. Cohort A did not enroll any unique patients in Part 2. Only patients who had a quantifiable plasma/serum concentration of tislelizumab at specified timepoints are reported.
Blood samples were collected at the specified timepoints to determine serum concentrations of tislelizumab.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=6 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=37 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 1 Day 1: Pre-infusion
|
0 micrograms per milliliter
Standard Deviation 0
|
—
|
0 micrograms per milliliter
Standard Deviation 0
|
0 micrograms per milliliter
Standard Deviation 0
|
0 micrograms per milliliter
Standard Deviation 0
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 1 Day 1: End of infusion
|
105 micrograms per milliliter
Standard Deviation 23.5
|
—
|
101 micrograms per milliliter
Standard Deviation 22.7
|
74.0 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
78.3 micrograms per milliliter
Standard Deviation 19.9
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 1 Day 8
|
49.5 micrograms per milliliter
Standard Deviation 12.7
|
—
|
54.4 micrograms per milliliter
Standard Deviation 15.1
|
45.2 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
39.2 micrograms per milliliter
Standard Deviation 10.0
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 1 Day 15
|
34.3 micrograms per milliliter
Standard Deviation 11.2
|
—
|
31.4 micrograms per milliliter
Standard Deviation 7.63
|
36.7 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
27.7 micrograms per milliliter
Standard Deviation 8.72
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 1 Day 21
|
27.3 micrograms per milliliter
Standard Deviation 13.1
|
—
|
28.1 micrograms per milliliter
Standard Deviation 6.58
|
—
|
20.3 micrograms per milliliter
Standard Deviation 5.58
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 2 Day 1: Pre-infusion
|
22.2 micrograms per milliliter
Standard Deviation 8.27
|
—
|
19.3 micrograms per milliliter
Standard Deviation 10.5
|
21.5 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
15.1 micrograms per milliliter
Standard Deviation 5.14
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 4 Day 1: Pre-infusion
|
29.9 micrograms per milliliter
Standard Deviation 11.8
|
—
|
41.0 micrograms per milliliter
Standard Deviation 15.5
|
46.6 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
25.1 micrograms per milliliter
Standard Deviation 8.64
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 4 Day 1: End of infusion
|
158 micrograms per milliliter
Standard Deviation 47.6
|
—
|
172 micrograms per milliliter
Standard Deviation 7.78
|
137 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
114 micrograms per milliliter
Standard Deviation 25.4
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 7 Day 1: Pre-infusion
|
57.2 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
—
|
50.0 micrograms per milliliter
Standard Deviation 31.0
|
—
|
35.5 micrograms per milliliter
Standard Deviation 14.4
|
|
Parts 1 and 2: Serum Concentrations of Tislelizumab
Cycle 13 Day 1: Pre-infusion
|
45.9 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
—
|
26.0 micrograms per milliliter
Standard Deviation NA
NA indicates that SD was not estimable for 1 patient.
|
—
|
34.9 micrograms per milliliter
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to end of treatment, up to approximately 17 months for Part 1 and 20 months for Part 2Population: The ADA analysis set included all patients who received at least 1 dose of tislelizumab and had a baseline and at least 1 post-baseline ADA result. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=6 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=10 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=1 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=29 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab
Treatment-Induced ADA
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
10 Participants
|
|
Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab
Treatment-Boosted ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 21 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type.
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was an abnormal pregnancy outcome in a child born to a female patient/female partner of a male patient exposed to study treatment or was an important medical event. TEAEs were AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
Outcome measures
| Measure |
Part 1: Solid Tumor of Any Type (IO-Treated/IO-Naïve in the Metastatic Setting)
n=1 Participants
Patients with advanced or metastatic solid tumors of any type who had progressed on standard systemic therapy and for which no effective therapy or standard of care existed and who were either IO-treated or IO-naïve in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion once Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=11 Participants
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=1 Participants
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 Participants
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|---|
|
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
TEAEs
|
1 Participants
|
11 Participants
|
1 Participants
|
39 Participants
|
—
|
|
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
TESAEs
|
0 Participants
|
2 Participants
|
1 Participants
|
20 Participants
|
—
|
|
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
TEAEs leading to fruquintinib treatment discontinuation
|
1 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
—
|
|
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
TEAEs leading to tislelizumab treatment discontinuation
|
1 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to end of treatment, up to approximately 20 monthsPopulation: The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. Based upon the strategic evaluation of clinical development of fruquintinib in the United States, the study was early terminated prior to data collection for this outcome measure.
Expression of PD-L1 biomarker was planned to be assessed in tumor tissues of the patients. Baseline was defined as the last non-missing assessment prior to the first administration of any study treatment (whichever occurred first), including scheduled and unscheduled visits, unless otherwise specified.
Outcome measures
Outcome data not reported
Adverse Events
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 8 deaths
Part 2: Cohort C: EC (IO-Naïve)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: Cohort D: MSS mCRC (IO-Naïve)
Serious events: 20 serious events
Other events: 39 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
n=1 participants at risk
Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=11 participants at risk
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=1 participants at risk
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 participants at risk
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Disease progression
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
Other adverse events
| Measure |
Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting)
n=1 participants at risk
Patients with advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had progressed on prior immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort B: TNBC (IO-Naïve in the Metastatic Setting)
n=11 participants at risk
Patients with locally advanced or metastatic TNBC including those with ER or PGR low positive disease who had progressed on at least 1 line, but no more than 3 lines, of cytotoxic therapy in the locally advanced or metastatic setting and had not received prior therapy with an ICI or other immunotherapy in the metastatic setting were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort C: EC (IO-Naïve)
n=1 participants at risk
Patients with advanced or metastatic EC who had progressed on 1 prior, platinum-based chemotherapy regimen for EC and had not received prior therapy with an ICI or other immunotherapy were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
Part 2: Cohort D: MSS mCRC (IO-Naïve)
n=39 participants at risk
Patients with unresectable advanced or metastatic MSS CRC who had failed 2 lines of standard chemotherapies, including fluorouracil, oxaliplatin, irinotecan and had received anti-VEGF (if RAS: wild-type tumor, mutated or status unknown) or EGFR (if RAS wild-type tumor) antibody treatment were included in this cohort. Patients received fruquintinib 5 mg orally QD for 3 weeks, followed by 1 week off in every 4-week cycle in combination with tislelizumab 300 mg IV infusion Q4W until radiologically determined PD per RECIST v 1.1, unacceptable toxicity, death, or withdrawal from study.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
36.4%
4/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
33.3%
13/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
45.5%
5/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Memory impairment
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
54.5%
6/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
25.6%
10/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
36.4%
4/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
23.1%
9/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
17.9%
7/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
17.9%
7/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
17.9%
7/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
45.5%
5/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
66.7%
26/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Chills
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Gait disturbance
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
General disorders
Localised oedema
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
23.1%
9/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
23.1%
9/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
10.3%
4/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Platelet count increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Weight increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood calcium increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Protein total increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Thyroxine increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
Tri-iodothyronine free increased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
10.3%
4/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
10.3%
4/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
20.5%
8/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
2.6%
1/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
28.2%
11/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
27.3%
3/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
28.2%
11/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
17.9%
7/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
7.7%
3/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
18.2%
2/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
15.4%
6/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
12.8%
5/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Cardiac disorders
Sinus bradycardia
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
5.1%
2/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Injury, poisoning and procedural complications
Fall
|
100.0%
1/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
9.1%
1/11 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/1 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
0.00%
0/39 • Adverse events were collected from the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 18 months for Part 1 and 21 months for Part 2. All-cause mortality (deaths) were collected from Day 1 up to end of follow up, approximately 34 months.
The SAS included all enrolled patients who received at least 1 dose of fruquintinib or tislelizumab. As pre-specified in SAP, all patients from Part 1 were also included in the relevant Cohorts in Part 2 based on their tumor type. Therefore, the results presented by Cohort for Part 2 are inclusive of Part 1.
|
Additional Information
William Schelman, MD, PhD, Senior Vice President, Clinical Development, US/Europe
HUTCHMED International, Inc.
Phone: +1 9733064490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place