Trial Outcomes & Findings for Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma (NCT NCT04974047)
NCT ID: NCT04974047
Last Updated: 2025-12-01
Results Overview
The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86
Results posted on
2025-12-01
Participant Flow
This study was conducted at 8 study centers in China.
Participant milestones
| Measure |
Cohort A (Responder)
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
40
|
|
Overall Study
Surgical Resection Performed
|
21
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
40
|
Reasons for withdrawal
| Measure |
Cohort A (Responder)
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Overall Study
Sponsor Ended Study
|
20
|
22
|
|
Overall Study
Death
|
8
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort A (Responder)
n=30 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=40 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.16 • n=9 Participants
|
63.1 years
STANDARD_DEVIATION 7.06 • n=6 Participants
|
63.7 years
STANDARD_DEVIATION 7.53 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
62 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
70 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
30 Participants
n=9 Participants
|
40 Participants
n=6 Participants
|
70 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
China
|
30 participants
n=9 Participants
|
40 participants
n=6 Participants
|
70 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86Population: The Efficacy Evaluable Analysis Set included all participants who received neoadjuvant treatment followed by surgery.
The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.
Outcome measures
| Measure |
Cohort A (Responder)
n=20 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=32 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Pathological Complete Response (pCR) Rate
|
30.0 percentage of participants
Interval 11.9 to 54.3
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
SECONDARY outcome
Timeframe: Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86Population: The Efficacy Evaluable Analysis Set included all participants who received neoadjuvant treatment followed by surgery.
Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins.
Outcome measures
| Measure |
Cohort A (Responder)
n=20 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=32 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
R0 Resection Rate
|
95.0 percentage of participants
|
90.6 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year and 3 years after surgeryPopulation: The Efficacy Evaluable Analysis Set with R0 resection included all participants who received neoadjuvant treatment followed by surgery with R0 resection. No participants were on follow-up for 3 years after surgery, so DFS rate at 3 years was not assessed.
The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Outcome measures
| Measure |
Cohort A (Responder)
n=19 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=29 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
1-year/3-year Disease-free Survival (DFS) Rate
1 Year
|
79.0 percentage of participants
Interval 47.9 to 92.7
|
74.2 percentage of participants
Interval 53.3 to 86.8
|
SECONDARY outcome
Timeframe: 1 year and 3 years after first dose datePopulation: The Safety Analysis Set included all participants who received at least one dose of any component of study drugs.
The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.
Outcome measures
| Measure |
Cohort A (Responder)
n=30 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=40 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
1-year/3-year Event-free Survival (EFS) Rate
1 Year
|
87.1 percentage of participants
Interval 64.3 to 95.8
|
67.8 percentage of participants
Interval 48.3 to 81.2
|
|
1-year/3-year Event-free Survival (EFS) Rate
3 Years
|
75.5 percentage of participants
Interval 49.8 to 89.3
|
59.9 percentage of participants
Interval 40.0 to 75.1
|
SECONDARY outcome
Timeframe: ORR was assessed prior to surgery, Day 71 to 86Population: The Safety Analysis Set with Measurable Disease at Baseline included all participants who had measurable disease at baseline and received at least one dose of any component of study drugs.
The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cohort A (Responder)
n=21 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=33 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
42.4 percentage of participants
Interval 25.5 to 60.8
|
SECONDARY outcome
Timeframe: From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months.Population: The Safety Analysis Set included all participants who received at least one dose of any component of study drugs.
Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab
Outcome measures
| Measure |
Cohort A (Responder)
n=30 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=40 Participants
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Number Of Participants Experiencing Treatment-Emergent Adverse Events
|
30 Participants
|
39 Participants
|
Adverse Events
Cohort A (Responder)
Serious events: 8 serious events
Other events: 30 other events
Deaths: 8 deaths
Cohort B (Non-responder)
Serious events: 12 serious events
Other events: 39 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Cohort A (Responder)
n=30 participants at risk
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=40 participants at risk
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Cardiac disorders
Acute coronary syndrome
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Death
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Neutrophil count decreased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
White blood cell count decreased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Nervous system disorders
Cerebral infarction
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
Other adverse events
| Measure |
Cohort A (Responder)
n=30 participants at risk
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
Cohort B (Non-responder)
n=40 participants at risk
Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
70.0%
21/30 • Number of events 30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
80.0%
32/40 • Number of events 47 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Cardiac disorders
Pericardial effusion
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
4/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
17.5%
7/40 • Number of events 9 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
4/30 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Nausea
|
36.7%
11/30 • Number of events 18 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
35.0%
14/40 • Number of events 32 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
10.0%
4/40 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
10/30 • Number of events 16 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
40.0%
16/40 • Number of events 29 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Asthenia
|
6.7%
2/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Chills
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Malaise
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
17.5%
7/40 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
10.0%
4/40 • Number of events 5 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Bronchiolitis
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
COVID-19
|
3.3%
1/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Eye infection
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Pneumonia
|
16.7%
5/30 • Number of events 5 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
15.0%
6/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
10.0%
4/40 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
16.7%
5/30 • Number of events 5 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
20.0%
8/40 • Number of events 9 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
17.5%
7/40 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Amylase increased
|
3.3%
1/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Bile acids increased
|
3.3%
1/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Blood creatinine increased
|
10.0%
3/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Blood glucose increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Blood magnesium decreased
|
3.3%
1/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
10.0%
4/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Psychiatric disorders
Insomnia
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Haematocrit decreased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Lipase increased
|
3.3%
1/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Lymphocyte count decreased
|
23.3%
7/30 • Number of events 8 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
22.5%
9/40 • Number of events 12 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 5 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Neutrophil count decreased
|
63.3%
19/30 • Number of events 41 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
85.0%
34/40 • Number of events 75 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Neutrophil count increased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Platelet count decreased
|
23.3%
7/30 • Number of events 10 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
30.0%
12/40 • Number of events 21 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Protein total decreased
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
20.0%
8/40 • Number of events 13 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
Weight decreased
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
25.0%
10/40 • Number of events 10 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
White blood cell count decreased
|
63.3%
19/30 • Number of events 41 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
87.5%
35/40 • Number of events 85 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Investigations
White blood cell count increased
|
6.7%
2/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
4/30 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
22.5%
9/40 • Number of events 9 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
3/30 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
25.0%
10/40 • Number of events 29 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.7%
2/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.3%
1/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
4/30 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
40.0%
16/40 • Number of events 22 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.3%
4/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 6 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
6/30 • Number of events 11 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
27.5%
11/40 • Number of events 22 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.3%
1/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
3/30 • Number of events 7 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 8 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
2/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 10 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
12.5%
5/40 • Number of events 5 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
3/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
7.5%
3/40 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
3/30 • Number of events 4 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
5.0%
2/40 • Number of events 2 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Number of events 3 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
2.5%
1/40 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
|
Vascular disorders
Phlebitis
|
3.3%
1/30 • Number of events 1 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
0.00%
0/40 • All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER