Moderna announced that five-year follow-up data from its Phase IIb study of the personalized cancer vaccine intismeran autogene, administered in combination with Merck’s anti-PD-1 therapy pembrolizumab (Keytruda), demonstrated a 49% reduction in the risk of recurrence or death versus pembrolizumab alone in patients with high-risk resected melanoma. The trial enrolled 312 patients with stage IIB to IIID disease, and intismeran autogene was tailored to each patient’s tumor neoantigen profile using Moderna’s mRNA platform. At the five-year landmark, 68% of patients in the combination arm remained disease-free compared with 47% in the monotherapy cohort. These results reinforce the potential of mRNA-based personalized immunotherapies to improve long-term outcomes in oncology and lay the groundwork for a planned Phase III confirmatory trial set to begin enrollment in mid-2026.

In an interview with Bloomberg TV, Moderna CEO Stephane Bancel revealed that the company will pause investments in new late-stage vaccine trials, citing growing opposition to immunization programs among certain U.S. policymakers and regulatory bodies. Bancel noted that, while Moderna remains committed to advancing its existing respiratory and prophylactic vaccine candidates through ongoing registrational studies, it will reallocate resources toward its oncology pipeline and rare disease mRNA programs. This strategic reprioritization follows increased scrutiny of vaccine mandates and public funding uncertainty, prompting Moderna to focus on higher-margin, late-stage therapeutic assets where regulatory pathways and reimbursement prospects are viewed as more favorable.