Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 antibody being studied for the treatment of colorectal cancer, specifically left-sided colorectal cancer. It is being evaluated in combination with chemotherapy for patients with RAS and BRAF wild-type, unresectable or metastatic disease. The drug is currently in Phase 3 clinical development and is not yet approved.
Petosemtamab is a monoclonal antibody, as indicated by its -mab suffix. Its specific molecular target is not disclosed in the available information. The drug is being studied in biomarker-selected patient populations with RAS and BRAF wild-type colorectal cancer, suggesting it may target a pathway relevant to these tumors.
Petosemtamab is being developed by Genmab A/S, a biopharmaceutical company listed on the Nasdaq under the ticker symbol GMAB. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with colorectal cancer.
Petosemtamab is currently in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 3 trials are planned but have not yet begun recruiting participants, indicating the drug is still in the clinical trial stage.
Petosemtamab is involved in two Phase 3 clinical trials. The first, NCT07702032, compares petosemtamab plus chemotherapy to cetuximab plus chemotherapy in left-sided colorectal cancer. The second, NCT07775287, compares petosemtamab plus chemotherapy to cetuximab or bevacizumab plus chemotherapy in colorectal cancer. Both trials are not yet recruiting.
Petosemtamab is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied as a potential treatment for colorectal cancer, and its unique mechanism and target differentiate it from existing therapies like cetuximab and bevacizumab, which are used as comparators in its clinical trials.