Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M7824 · 1 trial · 1 indication
Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| M7824 | EXPERIMENTAL | - |
| Pembrolizumab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| M7824 | DRUG | Participants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. |
| Pembrolizumab | DRUG | Pembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal. |
Inclusion Criteria: * Histologically confirmed diagnosis of advanced NSCLC * Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is a...
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M7824 is an investigational small molecule being studied for the first-line treatment of advanced Non-small Cell Lung Cancer (NSCLC) in patients whose tumors express PD-L1. It is being compared against pembrolizumab in a Phase 3 clinical trial. M7824 is not yet approved and remains in clinical development.
M7824 targets the PD-L1 pathway in the treatment of Non-small Cell Lung Cancer. The Phase 3 trial specifically enrolls participants with PD-L1 expressing advanced NSCLC, indicating that the drug's mechanism is directed at this biomarker. The drug is designed to interfere with PD-L1 signaling in tumor cells.
M7824 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the stock exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced Non-small Cell Lung Cancer.
M7824 is in Phase 3 clinical development. It is being studied in a completed Phase 3 trial for the first-line treatment of advanced Non-small Cell Lung Cancer with PD-L1 expression. The drug is investigational and has not received FDA approval for any indication.
M7824 has one completed Phase 3 clinical trial registered under NCT03631706. This trial compared M7824 versus pembrolizumab as a first-line treatment in 304 participants with PD-L1 expressing advanced Non-small Cell Lung Cancer. The study was conducted across multiple countries including the United States, China, Japan, and several European nations.
No, M7824 is not the same as pembrolizumab. M7824 is an investigational small molecule being developed by Merck & Company, while pembrolizumab is an approved PD-1 inhibitor. In the Phase 3 trial NCT03631706, M7824 was directly compared against pembrolizumab as an active control in patients with advanced Non-small Cell Lung Cancer.