Moderna, Merck post 5-year data for mRNA cancer vaccine in melanoma

Edited by Robert McTiernan··2 min read

Moderna and Merck reported five-year follow-up data showing sustained recurrence-free survival (RFS) benefits for their personalized mRNA cancer vaccine intismeran autogene when used with Keytruda in high-risk melanoma.

The updated data came from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, which is evaluating intismeran autogene (mRNA-4157) in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) following complete surgical resection in patients with stage III or IV melanoma.

At a median follow-up of approximately five years, the combination therapy continued to demonstrate a 49% reduction in the risk of recurrence or death compared with Keytruda alone, corresponding to a hazard ratio of 0.51. The RFS benefit observed at earlier interim analyses was maintained over the longer follow-up period.

According to Moderna and Merck, the safety profile of the combination remained consistent with previously reported data, with no new safety signals identified over extended follow-up. The two firms view the durability of the RFS benefit as an justifying the rationale for continued late-stage development of the combination in melanoma and supporting broader evaluation of personalized mRNA cancer vaccines in solid tumors.

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About intismeran autogene

Intismeran autogene is an individualized neoantigen therapy designed using mRNA technology to encode up to 34 patient-specific tumor neoantigens, identified through sequencing of a patient’s tumor. The vaccine is intended to prime the immune system to recognize and target residual cancer cells when administered alongside checkpoint inhibition.

The melanoma program represents the most advanced clinical effort for Moderna’s personalized cancer vaccine platform. The companies are also jointly developing the mRNA-based therapy with Keytruda across multiple tumor types, including non-small cell lung cancer, bladder cancer, and renal cell carcinoma, with several Phase 2 and Phase 3 studies ongoing.

Competitive context

Moderna and Merck’s melanoma data position the intismeran autogene programme among the most advanced efforts in personalised mRNA cancer vaccines, a field that remains highly competitive but largely early-stage, with few programmes approaching late-stage development. Key competitors include:

  • BioNTech / Genentech (Roche) – Autogene cevumeran (BNT122) Stage: Phase 1/2 Indications: Pancreatic cancer, melanoma, other solid tumours
  • BioNTech – BNT111 Stage: Early clinical Indication: Melanoma
  • BioNTech – BNT116 Stage: Early clinical Indication: Non-small cell lung cancer
  • CureVac – CV8102 Stage: Early clinical Indications: Solid tumours
  • Sanofi / BioNTech – SAR441000 Stage: Early clinical Indications: Solid tumours
  • Transgene – TG4050 Stage: Phase 1 Indications: Head and neck cancer, ovarian cancer