Phase III study evaluating V 940 + Keyruda is initiated for adjuvant treatment of patients with resected high-risk (stage IIB-IV) melanoma

Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.

V940-001 is a Phase III global, randomized, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of V 940 (mRNA-4157) in combination with Keytruda in people with resected high-risk (Stage IIB-IV) melanoma compared to Keytruda alone. The trial is slated to enroll approximately 1,089 patients at more than 165 sites in over 25 countries around the world. The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety.

Based on data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, the FDA and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for V 940 (mRNA-4157) in combination with Keytruda for the adjuvant treatment of patients with high-risk melanoma. The companies presented the study’s primary endpoint, RFS, in April 2023 at the American Association for Cancer Research (AACR) Annual Meeting and presented the study’s key secondary endpoint, DMFS, in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The companies also plan to expand the development program to additional tumor types, including non-small cell lung cancer.

About V940-001 ( NCT05933577 ): V940-001 is a global, randomized, double-blind, placebo- and active-comparator-controlled Phase III trial evaluating 1,089 patients with resected high-risk (Stage IIB-IV) melanoma. Following complete surgical resection, participants 18 years and older will be randomized 2:1 to receive V 940 (mRNA-4157) (1 mg every three weeks for up to nine doses) and Keytruda(400 mg every six weeks up to nine cycles [approximately one year]) versus Keytruda alone for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner. The primary endpoint is RFS, defined as the time from randomization to any type of disease recurrence as assessed by the investigator, or death due to any cause. The secondary endpoints are DMFS, OS, safety and quality of life. Key eligibility criteria for the trial include: patients who have surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III or IV cutaneous melanoma, patients who have not received any prior systemic therapy for their melanoma beyond surgical resection and no more than 13 weeks have passed between final surgical resection.