Trial Outcomes & Findings for A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma (NCT NCT04337931)

Last Updated: 2024-02-13

Results Overview

The percentage of participants having reached a confirmed Complete Response (CR) or Partial Response (PR) by RECIST 1.1, relative to the number of participants belonging to the Efficacy Population. Confidence Intervals (CIs) were calculated using exact (Clopper-Pearson) method. CR: Disappearance of all target lesions and nontarget (NT) lesions; PR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

12 months

Results posted on

2024-02-13

Participant Flow

A total of 45 participants were enrolled in Poland and Spain between June 2019 and August 2022.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.	Cohort 2 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.	Cohort 3 -Sotigalimab + Radiation Therapy Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
Overall Study STARTED	12	14	19
Overall Study Safety Population	12	13	19
Overall Study Efficacy Population	11	13	19
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	12	14	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants received 0.3mg/kg of sotigalimab administered intravenously (IV) every 21 days (3 week) treatment cycle.	Cohort 2 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.	Cohort 3 -Sotigalimab + Radiation Therapy Participants received 0.3 mg/kg of sotigalimab administered in combination with stereotactic body radiation therapy (SBRT) every 2 weeks (14-day cycle) up to 16 weeks followed by sotigalimab administered IV at 0.3 mg/kg every 2 weeks (14-day cycle).
Overall Study Death	4	1	7
Overall Study Withdrawal by Subject	0	1	0
Overall Study Initiation of subsequent anti-cancer treatment	1	0	9
Overall Study Study terminated by sponsor	3	6	2
Overall Study Initiated first treatment with anti-PD1/L1 therapy	3	5	1
Overall Study Colorectal cancer treatment	1	0	0
Overall Study Participant decision	0	1	0

Baseline Characteristics

A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=12 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycle.	Cohort 2 n=13 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle.	Cohort 3 n=19 Participants Participants received 0.3mg/kg of sotigalimab administered through IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.	Total n=44 Participants Total of all reporting groups
Age, Continuous	69.00 years n=99 Participants	59.00 years n=107 Participants	63.00 years n=206 Participants	62.50 years n=7 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants	20 Participants n=7 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants	24 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	3 Participants n=107 Participants	0 Participants n=206 Participants	3 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants	10 Participants n=107 Participants	19 Participants n=206 Participants	41 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) White	12 Participants n=99 Participants	13 Participants n=107 Participants	19 Participants n=206 Participants	44 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment Poland	1 participants n=99 Participants	1 participants n=107 Participants	8 participants n=206 Participants	10 participants n=7 Participants
Region of Enrollment Spain	11 participants n=99 Participants	12 participants n=107 Participants	11 participants n=206 Participants	34 participants n=7 Participants
Weight	77.20 kg n=99 Participants	79.00 kg n=107 Participants	75.00 kg n=206 Participants	78.10 kg n=7 Participants
Height	169.00 cm n=99 Participants	166.00 cm n=107 Participants	168.00 cm n=206 Participants	168.00 cm n=7 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (asymptomatic)	7 Participants n=99 Participants	8 Participants n=107 Participants	7 Participants n=206 Participants	22 Participants n=7 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (symptomatic but ambulatory)	5 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants	22 Participants n=7 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Participants evaluable for efficacy (tumor response) are defined as those who have measurable disease and at least one evaluable (post baseline) tumor assessment performed during the treatment period or within 30 days after the administration of the last dose of treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycles.	Cohort 2 n=13 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles.	Cohort 3 n=19 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Overall Response Rate (ORR)	9.09 percentage of participants Interval 0.47 to 36.44	7.69 percentage of participants Interval 0.39 to 31.63	0.00 percentage of participants Interval 0.0 to 14.59

SECONDARY outcome

Timeframe: 12 months

Population: iORR for iRECIST 1.1 by Cohort (Efficacy Population).

The percentage of participants having reached an immune confirmed Complete Response (iCR) or Partial Response (iPR) by iRECIST 1.1, relative to the number of participants belonging to the Efficacy Population. CIs were calculated using exact (Clopper-Pearson) method. iCR: Disappearance of all target lesions and NT lesions; iPR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycles.	Cohort 2 n=13 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles.	Cohort 3 n=19 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.
Modified RECIST 1.1 for Immune-based Therapeutics (iRECIST 1.1) Overall Response Rate (iORR)	9.09 percentage of participants Interval 0.47 to 36.44	7.69 percentage of participants Interval 0.39 to 31.63	0.00 percentage of participants Interval 0.0 to 14.59

SECONDARY outcome

Timeframe: 12 months

Population: DoR for RECIST 1.1 by Cohort (Efficacy Population). Inclusive of participants who experienced CR or PR only.

The DoR was defined as the time (in months) from the first evidence of confirmed objective response (CR or PR) to the event or censoring date. An event was defined as the first documentation of progression disease (PD; disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method. CR: Disappearance of all target lesions and NT lesions; PR: \>30% decrease in the sum of the longest diameter of target lesions and no progressive disease in NT lesions or new lesions; PD: \>20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1 n=1 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycles.	Cohort 2 n=1 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles.	Cohort 3 Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.
RECIST 1.1 Duration of Response (DoR)	NA months Median and CIs were not reached due to low number of events	NA months Median and CIs were not reached due to low number of events	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: PFS for RECIST 1.1 by Cohort (Efficacy Population).

The PFS was defined as the time (in months) from the first administration of APX005M to the event or censoring date. An event was defined as the first documentation of PD (disease progression assessed based on tumor assessment or clinical progression) or death due to any cause, whichever occurs earlier. Median DoR was calculated using Kaplan-Meier analysis. CIs were calculated using exact (Clopper-Pearson) method. PD: \>20% increase in the sum of the longest diameter of target lesions and an absolute increase of ≥5mm, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 21 days (3 week) treatment cycles.	Cohort 2 n=13 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycles.	Cohort 3 n=19 Participants Participants received 0.3mg/kg of sotigalimab administered IV every 14 days (2 week) treatment cycle in combination with stereotactic body radiation therapy (SBRT) every 14-day cycles (up to 16 weeks) followed by sotigalimab every 14 days.
RECIST 1.1 Progression-free Survival (PFS)	1.87 months Interval 1.35 to 3.71	3.48 months Interval 1.81 to 9.2	1.87 months Interval 1.64 to 1.91

Adverse Events

Cohort 1

Serious events: 7 serious events

Other events: 12 other events

Deaths: 4 deaths

Cohort 2

Serious events: 0 serious events

Other events: 12 other events

Deaths: 1 deaths

Cohort 3

Serious events: 3 serious events

Other events: 19 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=12 participants at risk Sotigalimab infusion (IV) 0.3 mg/kg every 3 weeks (21 day) treatment cycles.	Cohort 2 n=13 participants at risk Sotigalimab infusion (IV) 0.3 mg/kg every 2 weeks (14 day) treatment cycles.	Cohort 3 n=19 participants at risk Sotigalimab infusion (IV) 0.3 mg/kg every 2 weeks (14 day) treatment cycle plus Stereotactic Body Radiation Therapy (SBRT) every 14 day-cycles (up to 16 weeks) followed by sotigalimab every 14 days in adults with unresectable or metastatic melanoma who have failed any number of prior lines of therapy.
General disorders Gait disturbance	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
General disorders Pain	0.00% 0/12 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	5.3% 1/19 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Infections and infestations COVID-19	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Infections and infestations Pneumonia	8.3% 1/12 • Number of events 2 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Infections and infestations Skin infection	0.00% 0/12 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	5.3% 1/19 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Investigations Transaminases increased	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	8.3% 1/12 • Number of events 2 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Nervous system disorders Haemorrhagic stroke	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Psychiatric disorders Psychotic disorder	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Renal and urinary disorders Acute kidney injury	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/19 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 1/12 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	0.00% 0/13 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.	5.3% 1/19 • Number of events 1 • Up to approximately 79 weeks All AE's below are reported regardless of relationship to treatment.

Other adverse events

Additional Information

Pyxis Oncology Clinical Operations

Pyxis Oncology, Inc.

Phone: (339) 545 8252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60