Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Petosemtamab · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Petosemtamab + Pembrolizumab | EXPERIMENTAL | Combination Therapy |
| Pembrolizumab | ACTIVE_COMPARATOR | Monotherapy |
| MCLA-158 | EXPERIMENTAL | - |
| Investigator's Choice | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Petosemtamab | DRUG | MCLA-158 |
| Pembrolizumab | DRUG | Humanized Antibody |
| Investigator's Choice | DRUG | Cetuximab |
Inclusion Criteria: 1. Signed ICF before initiation of any study procedures 2. Age ≥ 18 years at signing of ICF 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. 4. The eligible HNSCC primary tumor location...
Petosemtamab is an investigational bispecific antibody being developed for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). It is currently in Phase 3 clinical trials for this indication, including as a monotherapy in previously treated patients and in combination with pembrolizumab as a first-line treatment.
Petosemtamab is a bispecific antibody, a type of -mab (antibody) therapeutic. It is designed to target two antigens involved in tumor growth and immune evasion, though the specific molecular targets are not disclosed in the available information. Its mechanism of action is under investigation in clinical trials.
Petosemtamab is being developed by Merus N.V., a clinical-stage biopharmaceutical company. Merus is publicly traded on the Nasdaq under the ticker symbol MRUS. The company is conducting Phase 3 trials to evaluate the drug in head and neck cancer.
Petosemtamab is in Phase 3 clinical development. It has received Breakthrough Therapy and Fast Track designations from the FDA for the treatment of Head and Neck Squamous Cell Carcinoma. It is not yet approved and remains investigational.
Petosemtamab is being studied in two Phase 3 trials. NCT06496178 (LiGeR-HN2) compares petosemtamab monotherapy to investigator's choice in previously treated HNSCC, with 600 participants. NCT06525220 (LiGeR-HN1) evaluates petosemtamab plus pembrolizumab versus pembrolizumab alone in first-line HNSCC, with 700 participants. Both are recruiting.
Petosemtamab is a unique investigational bispecific antibody developed by Merus N.V. It is not known to be the same as any other approved or investigational drug. It is being studied under its own name in clinical trials for head and neck cancer.