Moderna to Present Phase 1/2 Data on Cancer Therapy mRNA-4359 at AACR

The investigational therapy showed promising results in combination with pembrolizumab for locally advanced or metastatic melanoma.

Apr. 17, 2026 at 7:09pm

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A highly detailed, translucent X-ray-style photograph revealing the intricate internal structures of a melanoma tumor, with glowing, ghostly lines and shapes against a dark background, conceptually representing the advanced science behind mRNA-based cancer therapies.An X-ray-like view into the complex biology of melanoma, hinting at the potential of mRNA technology to target the disease at a deep, molecular level.San Diego Today

Moderna announced it will present data from a Phase 1/2 study of its investigational cancer antigen therapy mRNA-4359 at the American Association for Cancer Research (AACR) Annual Meeting. The study evaluated mRNA-4359 in combination with pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma, showing an 83% overall response rate and a manageable safety profile.

Why it matters

This early data supports the potential of mRNA technology to help direct the immune system against melanoma, a serious and difficult-to-treat form of skin cancer. The consistent activation of antigen-specific T-cell responses provides evidence that mRNA-based therapies could be used to target cancer in a multi-targeted manner.

The details

Among 12 participants, mRNA-4359 plus pembrolizumab resulted in an 83% overall response rate, with two complete responses and eight partial responses. The therapy also demonstrated a 92% disease control rate. Responses occurred across baseline tumor PD-L1 expression categories. The combination showed a manageable safety profile with no new immune-related adverse events.

  • The presentation will take place on Monday, April 20, 2026 from 10:15AM to 12:15PM PT at the AACR Annual Meeting in San Diego.
  • Moderna previously presented promising early data on mRNA-4359 plus pembrolizumab at the 2025 European Society for Medical Oncology Congress.

The players

Moderna, Inc.

A pioneer and leader in the field of mRNA medicine, developing vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

Dr. Pavlina Spiliopoulou

The lead author and presenter of the abstract, from the School of Cancer Sciences at the University of Glasgow in the UK.

David Berman, M.D., Ph.D.

The Chief Development Officer of Moderna.

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What they’re saying

“This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient's journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results.”

— David Berman, M.D., Ph.D., Chief Development Officer of Moderna

“This early data supports the potential activity of the mRNA-4359 + pembrolizumab combination, with promising anti-tumor activity. The consistent activation of antigen-specific T-cell responses provides important early evidence that mRNA technology could be used to help direct the immune system against melanoma in a multi-targeted manner.”

— Dr. Pavlina Spiliopoulou, Lead Author and Presenter, School of Cancer Sciences, University of Glasgow

What’s next

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of checkpoint inhibitor refractory unresectable or metastatic melanoma with PD-L1+ tumors, which could help expedite the development and review of this therapy.

The takeaway

This early data on mRNA-4359 plus pembrolizumab demonstrates the potential of mRNA technology to harness the immune system and target cancer in new ways, providing hope for patients with advanced melanoma who have limited treatment options.