Moderna and Merck reported that their investigational personalized cancer vaccine, intismeran autogene, when combined with Keytruda, achieved a 49% reduction in the risk of melanoma recurrence or death versus Keytruda alone in high-risk stage III and IV patients. The phase IIb trial enrolled 312 participants across 45 sites in North America and Europe, with a median follow-up of 62 months. Disease-free survival at five years was 68% in the combination arm versus 46% in the control arm. Enrollment criteria included patients with resected melanoma carrying at least one recurrence risk factor, and safety data showed no new grade 3 or higher adverse events related to the vaccine. These results position Moderna’s neo-antigen platform as a leading candidate in adjuvant oncology, supporting plans to initiate a pivotal phase III registration study by mid-2026.

In a recent interview, CEO Stephane Bancel announced that Moderna will not initiate any new late-stage vaccine trials over the next 12–18 months, due to growing opposition from U.S. federal officials and certain state legislators. The decision affects mRNA programs targeting influenza, RSV and emerging coronaviruses, representing a reallocation of approximately $400 million in annual R&D spending toward oncology and rare genetic disease pipelines. Bancel highlighted that current public debate has led to extended regulatory review timelines and increased post-authorization requirements, eroding expected trial efficiencies. Moderna will continue phase III commitments already underway, including its quadrivalent seasonal flu candidate, but will defer new trial starts until the regulatory environment stabilizes.