Merck halts melanoma coformulation trial arm after futility analysis

Merck halts melanoma coformulation trial arm after futility analysis

RAHWAY, N.J. - Merck (NS: PROR ) & Co. Inc. (NYSE: MRK) announced today the discontinuation of a specific arm in its Phase 3 KeyVibe-010 trial, which was assessing a combination therapy involving vibostolimab and pembrolizumab in patients with resected high-risk melanoma.

The decision followed a pre-planned analysis indicating that the trial is unlikely to meet the primary endpoint of recurrence-free survival (RFS).

The halted arm of the study was comparing the coformulation of vibostolimab, an anti-TIGIT antibody, with pembrolizumab, Merck's own anti-PD-1 therapy, against pembrolizumab alone. The independent Data Monitoring Committee (DMC) recommended the unblinding of the study after observing a higher discontinuation rate due to immune-mediated adverse experiences in the coformulation arm compared to the monotherapy arm.

Patients currently receiving the coformulation will be offered the option to switch to pembrolizumab monotherapy. Merck remains committed to exploring and advancing treatments for melanoma, including the ongoing Phase 3 V940-001 study in collaboration with Moderna (NASDAQ: MRNA ), which is evaluating a neoantigen therapy combined with pembrolizumab.

Despite this setback, Merck's clinical program continues to evaluate the safety and efficacy of the vibostolimab and pembrolizumab coformulation in over 3,000 patients across various cancers. The company has stated that the findings from the KeyVibe-010 study are not expected to impact ongoing Phase 3 trials in lung cancer, where interim safety reviews have not necessitated any changes.

The information in this article is based on a press release statement from Merck & Co., Inc.

InvestingPro Insights

In light of Merck & Co.'s recent announcement regarding the Phase 3 KeyVibe-010 trial, investors may be looking for stability and growth prospects within the company. According to InvestingPro data, Merck boasts a robust market capitalization of $329.42 billion and has shown a revenue growth of 6.11% over the last twelve months as of Q1 2024. Furthermore, the company's gross profit margin stands at an impressive 74.85% in the same period, reflecting its strong position in the pharmaceutical industry.

Merck's commitment to dividend growth is also noteworthy, with the company having raised its dividend for 13 consecutive years and maintaining dividend payments for 54 consecutive years. This consistent return to shareholders underscores Merck's financial resilience and long-term strategy. Additionally, the InvestingPro Tips highlight that analysts have revised their earnings upwards for the upcoming period, which could signal confidence in the company's future performance despite the recent clinical trial setback.

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