Merck, in partnership with Moderna, announced that it has initiated a new phase III trial to evaluate the safety and efficacy of the investigational individualized neoantigen therapy V940 (mRNA-4157) in combination with pembrolizumab to treat patients with resected stage IIb to IV melanoma. The announcement comes after researchers reported positive results from the phase IIb KEYNOTE-942/mRNA-4157-P201 study at the American Association for Cancer Research Annual Meeting 2023 and the 2023 ASCO Annual Meeting. The researchers demonstrated that among patients with melanoma, V940 (mRNA-4157) in combination with pembrolizumab reduced the risk of recurrence or mortality by 44% compared with pembrolizumab monotherapy. As a result, the FDA and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines scheme, respectively, to the combination treatment. The researchers plan to enroll 1,089 patients from 25 countries to analyze recurrence-free survival, overall survival, and safety in the new phase III trial.
August 02, 2023