Merck and Moderna announced in a press release that the FDA has granted Breakthrough Therapy designation to its joint personalized vaccine mRNA-4157/V940 in combination with the PD-1 inhibitor pembrolizumab to treat patients with high-risk melanoma following surgical resection. The designation is based on preliminary results from the randomized phase IIb KEYNOTE-942/mRNA-4157-P201 trial demonstrating that the novel combination may be effective in treating this patient population. Researchers hope to conduct further clinical trials examining the efficacy and full benefits of the combination therapy in patients with high-risk melanoma and develop additional trials testing the vaccine’s potential in other tumor types such as non–small cell lung cancer.
May 24, 2023