Phase 3 Clinical Trial Demonstrates 44% Reduction in Oncology Recurrence for mRNA Therapeutic Vaccine

CAMBRIDGE, MA — Clinical investigators from Moderna and global oncology research centers announced breakthrough Phase 3 trial results Wednesday for an individualized mRNA therapeutic cancer vaccine, demonstrating a 44 percent reduction in the risk of disease recurrence or death when combined with checkpoint inhibitor immunotherapy in high-risk melanoma patients.

Clinical Trial Protocol and Scientific Data

The randomized Phase 3 trial enrolled 1,089 patients across 12 countries who had undergone surgical resection for stage III and IV melanoma. The personalized vaccine, mRNA-4157 (V940), is custom-engineered for each patient by sequencing tumor samples to identify up to 34 unique neoantigens, training the patient's immune system to target micro-metastatic cancer cells.

At three years of median follow-up, 72.8 percent of patients receiving the combination therapy remained disease-free, compared to 55.6 percent of patients receiving standard immunotherapy alone.

Regulatory Submissions and Commercial Implications

Following the presentation of the certified trial data at medical conferences, development teams announced plans to file for accelerated approval with the U.S. FDA, the European Medicines Agency, and Health Canada by the fourth quarter of 2026.

Shares of Moderna surged on equity markets following the announcement, with healthcare analysts projecting that individualized mRNA oncology therapies could transform adjuvant cancer treatments across non-small cell lung cancer, pancreatic cancer, and renal cell carcinoma.

Next Steps in Clinical Expansion

Investigators confirmed that ongoing Phase 3 trials evaluating the mRNA platform in postoperative lung and bladder cancer cohorts will deliver preliminary interim readouts in early 2027.