Merck & Co. (MRK) and Moderna Inc. (MRNA) have announced the initiation of a Phase 3 trial to evaluate the efficacy of Moderna’s V940 in combination with Merck’s Keytruda as a treatment for patients with high-risk melanoma (Stage IIB-IV). This trial marks a significant milestone in the comprehensive clinical development program following positive results from a Phase 2 trial presented at the AACR and ASCO cancer conferences earlier this year.
Global Recruitment and Enrollments Underway
The multinational trial has commenced global recruitment, with Australia serving as the first country to enroll patients. A total of 1,089 patients are anticipated to be enrolled across 165 sites in over 25 countries.
Key Endpoints and Safety Measures
The primary endpoint of this study is recurrence-free survival (RFS), while secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety. Both companies emphasize the significance of these objectives in evaluating the treatment’s effectiveness and ensuring patient well-being.
Market Reaction
Merck’s stock experienced a marginal premarket decline, while Moderna’s stock saw a modest 1% increase, reflecting positive market sentiment towards this collaboration.
This partnership between Merck and Moderna holds great promise in advancing melanoma treatment options. With the Phase 3 trial now underway, both companies are eager to explore the potential benefits of combining V940 with Keytruda, bringing hope to individuals with high-risk melanoma worldwide.