On Monday, Merck & Co Inc (NYSE:MRK) revealed that it would discontinue the clinical development programs for vibostolimab and favezelimab.
Vibostolimab is being evaluated as an investigational fixed-dose combination with Keytruda (pembrolizumab) in the KeyVibe program.
Favezelimab is being evaluated as an investigational fixed-dose combination with pembrolizumab in the KEYFORM program.
Merck is discontinuing the Phase 3 KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with non-small cell lung cancer (NSCLC), based on the recommendation of an independent Data Monitoring Committee (DMC).
In a pre-planned analysis, both trials met the pre-specified futility criteria for the primary endpoint of overall survival.
As expected with dual checkpoint inhibitor therapy, more immune-related adverse events were observed with the fixed-dose combination than with pembrolizumab.
Considering the totality of data from the Phase 3 KeyVibe studies, including the efficacy outcomes from KeyVibe-003 and KeyVibe-007, the company has decided to discontinue the Phase 3 KeyVibe-006 trial and other vibostolimab studies.
Separately, Merck will end the favezelimab clinical development program and stop enrollment in the Phase 3 KEYFORM-008 trial of a fixed-dose combination of favezelimab and pembrolizumab for relapsed or refractory classical Hodgkin lymphoma (cHL) whose disease has progressed following prior anti-PD-1 therapy.
Patients currently in this trial may continue therapy until the study is completed.
KEYFORM-008 is the only Phase 3 study in the KEYFORM clinical development program for which results are not available.
The company made this decision after a thorough evaluation of data from the favezelimab clinical program and will prioritize the development of other candidates in its comprehensive and diversified oncology pipeline.
This decision is not based on any concerns about the safety of this fixed-dose combination.
On Tuesday, the FDA accepted Merck's Biologics License Application (BLA) for clesrovimab (MK-1654), the company's investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.
The FDA has set June 10, 2025, as the target action date for the Prescription Drug User Fee Act (PDUFA).
The application is supported by results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) of a single dose of clesrovimab administered to healthy preterm and full-term infants and interim results from the ongoing Phase 3 SMART trial (MK-1654-007) of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease.
If approved, Merck anticipates that clesrovimab will be available for physicians and healthcare administrators to order by July 2025, with shipments arriving in time for the 2025 RSV season.
Price Action: MRK stock is up 0.10% at $100.16 at last check Tuesday.
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