Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MGA012, INCMGA00012
retifanlimab · 1 trial · 3 indications
Evaluation of adverse events and serious adverse events (Cohort A)
Percent of non MSI-H participants with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A ) based on investigator assessment. CR is defined as the disappearance of all target and non-target lesions with no new lesions appearing PR is defined as \>= to a 30% decrease in the sum of the longest dimensions of target lesions, non-progression of non- target lesions, with no new lesions appearing. CR + PR = ORR
| Arm | Type | Description |
|---|---|---|
| Chemotherapy-free arm | EXPERIMENTAL | margetuximab plus retifanlimab |
| Margetuximab, retifanlimab, and chemotherapy arm | EXPERIMENTAL | margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Margetuximab, tebotelimab and chemotherapy arm | EXPERIMENTAL | margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Margetuximab and chemotherapy arm | EXPERIMENTAL | margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Trastuzumab and chemotherapy arm | ACTIVE_COMPARATOR | Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6) |
| Name | Type | Description |
|---|---|---|
| margetuximab | BIOLOGICAL | margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle |
| Retifanlimab | BIOLOGICAL | Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle. |
| Tebotelimab | BIOLOGICAL | Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle. |
| Trastuzumab | BIOLOGICAL | Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle |
| Chemotherapy | OTHER | Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 Chemotherapy XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion. |
Key Inclusion Criteria: * Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma 1. Prior systemic perioperative treatment is allowed; however the participants must have had a disease-free interval of at least 6 month...
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Retifanlimab is an investigational monoclonal antibody being studied for gastric cancer, including gastroesophageal junction cancer and HER2-positive gastric cancer. It is being developed by MacroGenics, Inc. as a potential treatment in oncology. It has not been approved for commercial use and remains in clinical development.
Retifanlimab targets PDCD1, also known as PD-1, a checkpoint receptor on immune cells. It acts as an antagonist, blocking this target to interfere with PD-1 mediated signaling. This mechanism is intended to support immune activity against tumor cells in gastric cancer.
Retifanlimab is being developed by MacroGenics, Inc., which trades under the ticker MGNX. The company is the sponsor of the clinical program evaluating the antibody in gastric cancer and related gastroesophageal junction cancer settings.
Retifanlimab is in Phase 2 development for gastric cancer. It is an investigational agent and has not been approved by the FDA. The clinical program includes one completed trial, and no active trials are currently listed for this asset.
Retifanlimab was evaluated in the Phase 2/3 trial NCT04082364, which studied a combination of margetuximab, retifanlimab, tebotelimab, and chemotherapy in HER2-positive gastric and gastroesophageal junction cancer. The trial enrolled 82 participants, was randomized and actively controlled, and has completed.
Yes. The retifanlimab gastric cancer trial NCT04082364 was biomarker selected, enrolling patients with HER2-positive gastric or gastroesophageal junction cancer. The study was randomized and active controlled, enrolled 82 participants aged 18 years and older, and included sites across the United States, China, Germany, Italy, Poland, Singapore, South Korea, Taiwan, and the United Kingdom.