The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. The combination produced statistically significant and clinically meaningful improvements compared with Keytruda alone, the companies said.

INTerpath-001 included 1,137 patients with stage IIB, IIC, III, or IV cutaneous melanoma who had not previously received systemic therapy. Patients were randomized to receive either intismeran plus Keytruda or Keytruda alone as adjuvant treatment after surgery.

The study will continue to assess additional endpoints, including overall survival. The companies reported no new safety signals, with the safety profile consistent with earlier studies of the combination.

“These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality,” said Stéphane Bancel, CEO of Moderna. “Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting. We are deeply grateful to the patients, investigators and study teams whose contributions make this progress possible.”

Related article

From theory to therapy: Cancer vaccines

Just ten years ago it was hard to predict the progress that has been made within the field of cancer therapy. A cancer vaccine, including a universal cancer vaccine, as the ultimate goal is for many the holy grail, and several Norwegian companies are paving the way.

Personalized cancer vaccine

Intismeran autogene, also known as V940 or mRNA-4157, is an investigational, individualized mRNA-based neoantigen therapy. It is designed using a patient’s tumor sample to identify mutations unique to that cancer and generate a targeted immune response.

The treatment contains synthetic mRNA coding for up to 34 neoantigens. Once administered, these sequences are presented to the immune system to stimulate T-cell responses against cancer cells.

Merck and Moderna plan to present the data at an upcoming international medical meeting and engage with regulatory authorities about potential submissions. The companies are also studying intismeran in nine Phase 2 and Phase 3 trials across melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma.

This article is based on a company announcement. Detailed efficacy data from INTerpath-001 have not yet been publicly presented.