A New Milestone in Melanoma: Personalized mRNA-Based Cancer Therapy Shows Positive Phase 3 Results

Today brought very encouraging news for people affected by melanoma.

Moderna and Merck announced positive results from a large Phase 3 clinical trial testing a novel mRNA-based individualized neoantigen cancer therapy (also known as intismeran or V940) combined with Keytruda for patients with high-risk melanoma whose cancer had been completely removed by surgery.

What did the study find?

The INTerpath-001 trial included 1,137 patients with resectable Stage IIB–IV melanoma. Researchers found that combining this personalized mRNA-based cancer therapy with Keytruda (pembrolizumab) significantly improved the amount of time patients remained cancer-free and reduced the risk of melanoma spreading to other parts of the body, compared with Keytruda alone. No new safety concerns were identified.

Notably, results from this Phase 3 readout builds upon positive Phase 2 trial data that were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

This is especially exciting because it is the first successful Phase 3 trial of a personalized mRNA-based cancer therapy—an approach that uses information from an individual patient's tumor to create a treatment specifically designed to help their immune system recognize and attack their cancer.

What happens next?

There are still important questions to answer. Moderna and Merck have announced the topline findings, but we have not yet seen the complete Phase 3 data, including exactly how large the benefit was. Those results are expected to be presented at an upcoming medical meeting and shared with regulatory authorities.

Researchers will also continue following patients to determine whether the treatment continues to achieve the same sustained success and safety profile at future milestones. Importantly, this therapy is not yet FDA approved. Today's results are an important step toward potentially making it available to patients in the future.

MRA's connection to this progress

‍We are proud that researchers who have received MRA funding have played important roles in this work. Dr. Georgina Long is leading the Phase 3 study, and MRA-funded investigators, including Dr. Jason Luke, Dr. Ryan Sullivan, and Dr. Ben Izar, have been involved in the trial. We also remember the late Dr. Jeffrey Weber, a longtime member of the MRA scientific community and an MRA-funded investigator, who played a leading role in the earlier Phase 2b study that helped establish the promise of this personalized mRNA approach and paved the way for the Phase 3 trial reporting positive results today.

For MRA, today's news is also a reminder of why investing in research and researchers matters. Breakthroughs rarely happen overnight. They are built over years through discoveries in the laboratory, collaboration across institutions and industry—and critically, upon patients who volunteer to participate in clinical trials.

Melanoma helped demonstrate the transformative potential of immunotherapy in treating cancer. Now, melanoma may once again be helping to open a new chapter in cancer care—this time through a personalized mRNA-based cancer therapy. There is more to learn, and we will keep our community informed as the full results become available. Today is an important and encouraging milestone for everyone working toward better outcomes for patients with melanoma.