Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intismeran · 1 trial · 1 indication
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa | EXPERIMENTAL | Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection. |
| Arm B: Intismeran | EXPERIMENTAL | Participants will receive intismeran 1 mg via IM injection. |
| Arm C: Placebo | PLACEBO_COMPARATOR | Participants will receive dose-matched placebo via IM injection. |
| Name | Type | Description |
|---|---|---|
| Intismeran | BIOLOGICAL | IM injection |
| Pembrolizumab coformulated with berahyaluronidase alfa | BIOLOGICAL | SC injection |
| Placebo | OTHER | IM injection |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk ...
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Intismeran is an investigational monoclonal antibody being studied for the treatment of Non-Small Cell Lung Cancer. It is currently in Phase 3 clinical development as an adjuvant therapy for high-risk Stage I disease, meaning it is given after surgery to help prevent the cancer from returning.
Intismeran is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated in combination with pembrolizumab coformulated with berahyaluronidase alfa in a Phase 3 clinical trial for Non-Small Cell Lung Cancer.
Intismeran is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 3 clinical trial of the drug as an adjuvant treatment for high-risk Stage I Non-Small Cell Lung Cancer.
Intismeran is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting patients with high-risk Stage I Non-Small Cell Lung Cancer to evaluate the drug as an adjuvant therapy.
Intismeran is being studied in one active Phase 3 clinical trial with the identifier NCT07513376. This randomized, double-blind, placebo-controlled trial is evaluating adjuvant Intismeran with or without pembrolizumab coformulated with berahyaluronidase alfa in high-risk Stage I Non-Small Cell Lung Cancer, with a planned enrollment of 876 participants.
Intismeran is also known as V940, as indicated by the clinical trial title. The Phase 3 study NCT07513376 refers to the drug as Intismeran (V940), confirming that these names refer to the same investigational monoclonal antibody being developed by Merck for Non-Small Cell Lung Cancer.