Moderna and Merck Report Sustained 49% Risk Reduction in Recurrence or Death with mRNA-Keytruda Combo at Five Years in Melanoma Trial
At five-year follow-up in the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, intismeran autogene (mRNA-4157/V940) combined with Keytruda reduced the risk of recurrence or death by 49% (HR=0.510; 95% CI, 0.294–0.887) versus Keytruda alone in patients with high-risk resected stage III/IV melanoma.12
This matches the 49% risk reduction seen at the three-year mark (December 2023) and builds on the initial 44% reduction at two years (December 2022).12
The therapy is an investigational mRNA-based individualized neoantigen therapy given post-surgical resection alongside Keytruda for one year; safety profile remains consistent with prior readouts.12
Data announced January 20, 2026; further analyses to be presented at an upcoming medical meeting, with a Phase 3 trial (V940-001) ongoing.23
Analysts view the sustained benefit positively, supporting durable tumor control and potential market entry by 2027-2028.1
Sources:
1. https://www.biospace.com/drug-development/moderna-merck-show-long-term-survival-for-mrna-keytruda-combo
2. https://www.merck.com/news/moderna-merck-announce-5-year-data-for-intismeran-autogene-in-combination-with-keytruda-pembrolizumab-demonstrated-sustained-improvement-in-the-primary-endpoint-of-recurrence-free-survival-i/
3. https://www.clinicaltrialsarena.com/news/moderna-cancer-vaccine-intismeran-autogene-keytruda-melanoma-phase-iib/