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Also known as MCLA-158, GEN1158
Petosemtamab · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm A: Petosemtamab + IC Chemotherapy (FOLFIRI or mFOLFOX6) | EXPERIMENTAL | Participants will receive petosemtamab 1500 milligrams (mg) once every 2 weeks (Q2W) + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W. |
| Arm B: IC Cetuximab or Bevacizumab + IC Chemotherapy (FOLFIRI or mFOLFOX6) | ACTIVE_COMPARATOR | Participants will receive IC cetuximab 500 milligrams per meter squared (mg/m\^2) or bevacizumab 5 milligrams per kilogram (mg/kg) Q2W + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W. |
| Petosemtamab + IC Chemotherapy | EXPERIMENTAL | Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI). |
| Cetuximab + IC Chemotherapy | ACTIVE_COMPARATOR | Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI). |
| Name | Type | Description |
|---|---|---|
| Petosemtamab | DRUG | Intravenous (IV) infusion. |
| Cetuximab | DRUG | IV infusion. |
| Bevacizumab | DRUG | IV infusion. |
| 5-FU | DRUG | IV infusion. |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion. |
| Oxaliplatin | DRUG | IV infusion. |
| Irinotecan | DRUG | IV infusion. |
| FOLFIRI | DRUG | Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion. |
| mFOLFOX6 | DRUG | Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion. |
Key Inclusion Criteria: * Histologically or cytologically confirmed colorectal adenocarcinoma that is recurrent, unresectable or metastatic. * Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing or as assessed by central testing. Next-generation ...
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Petosemtamab is an investigational monoclonal antibody being studied for colorectal cancer, including left-sided colorectal cancer. Development focuses on RAS and BRAF wild-type, recurrent, unresectable or metastatic disease. It is not yet approved for any indication and remains in clinical development.
Petosemtamab is being developed by Genmab A/S, which trades under the ticker GMAB. Genmab is the sponsor of the clinical program evaluating the antibody in colorectal cancer.
Petosemtamab is in Phase 3 clinical development. Two Phase 3 trials are registered, both currently listed as not yet recruiting. The drug is investigational and has not been approved by the FDA for any indication.
Petosemtamab is being evaluated in two Phase 3 trials. NCT07775287, known as LiGeR-CRC2, tests Petosemtamab plus chemotherapy versus cetuximab or bevacizumab plus chemotherapy in RAS and BRAF wild-type, recurrent, unresectable or metastatic colorectal cancer. NCT07702032 compares Petosemtamab plus chemotherapy with cetuximab plus chemotherapy in RAS and BRAF wild-type, unresectable or metastatic, left-sided colorectal cancer.
The Petosemtamab Phase 3 program plans to enroll 960 patients in NCT07702032 and 600 patients in NCT07775287. Both studies are randomized, active-controlled trials in adults aged 18 years and older, and both are currently not yet recruiting.
Yes. The Petosemtamab Phase 3 trials enroll patients with RAS and BRAF wild-type colorectal cancer, meaning eligibility is defined by tumor biomarker status. Both studies are randomized and active-controlled, comparing Petosemtamab plus chemotherapy against established antibody plus chemotherapy regimens.