Merck and Moderna's Intismeran Plus KEYTRUDA Combination Therapy Meets Key Melanoma Trial Endpoints

A landmark moment for adjuvant melanoma treatment has been reached with Merck and Moderna's combination therapy of intismeran plus KEYTRUDA. The Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival, as well as a key secondary endpoint of distant metastasis-free survival.

The trial involved 1,137 patients with high-risk resected cutaneous melanoma and showed that the combination produced statistically significant and clinically meaningful improvements in both measures compared to KEYTRUDA alone. This is the first positive Phase 3 readout for an individualized neoantigen therapy and the first positive Phase 3 readout for an mRNA-based cancer therapy.

Intismeran, also known as V940 or mRNA-4157, is a treatment designed based on the unique mutational 'fingerprint' of a patient's own tumor. It works by training and activating the patient's immune system to recognize and attack cancer cells carrying specific mutations.

Merck and Moderna plan to present the detailed Phase 3 results at an upcoming international medical meeting and share the findings with regulatory authorities. The companies also plan to engage regulators regarding potential filing submissions for intismeran in combination with KEYTRUDA.