Intismeran autogene with KEYTRUDA beats Keytruda alone in Phase 3 melanoma trial

Merck and Moderna said the Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival, with the combination improving both over KEYTRUDA alone in patients with completely resected melanoma. Moderna shares more than doubled on the day, with reported gains between roughly 130% and 177% depending on the source and time of day. The companies did not disclose hazard ratios or other effect sizes, and overall survival is still being evaluated.

• 1,137 patients with completely resected stage IIB-IV cutaneous melanoma, randomized 2:1
• Primary endpoint recurrence-free survival met; key secondary distant metastasis-free survival met
• No hazard ratios or effect sizes disclosed in the topline release
• Overall survival still being evaluated; detailed data to be presented at a future medical meeting
• Reports put the day's share gain between about 130% and 177%