Merck and Moderna's Cancer Therapy Trial Posts Significant Gains

Merck and Moderna have released positive topline results from their Phase 3 trial of personalized cancer therapy for advanced skin cancer. The companies shared data from the INTerpath-001 trial, which tested intismeran autogene (intismeran; V940 or mRNA-4157) in combination with Keytruda (pembrolizumab) in patients with completely resected stage IIB-IV melanoma.

The treatment, an mRNA-based individualized neoantigen therapy designed specifically for each patient based on the unique set of mutations within their tumor, showed statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to Keytruda alone. Safety profiles matched previous study results without generating new safety signals.

The readout represents the first positive Phase 3 result for an individualized neoantigen therapy and an mRNA-based cancer treatment, as well as the first Phase 3 trial demonstrating a clinically meaningful improvement over Keytruda monotherapy in the adjuvant setting for resected melanoma. Researchers will continue to track secondary metrics, including overall survival.