Moderna and Merck Launch Phase 2 Trial of mRNA Cancer Vaccine in Lung Cancer

Moderna and Merck have begun recruiting for a Phase 2 trial testing V940, an mRNA-based personalized cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.

Moderna announced an update on a Phase 2 clinical trial testing its mRNA-based cancer vaccine V940 in combination with standard therapy for advanced lung cancer. The trial, designated INTerpath-013, is recruiting patients with metastatic squamous non-small cell lung cancer who have not received prior treatment.

The study evaluates V940, an mRNA-based cancer vaccine also known as mRNA-4157 or Intismeran Autogene, given as an injection to help the immune system better recognize and attack each patient's tumor. It is tested in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab) and standard chemotherapy drugs carboplatin plus paclitaxel or nab-paclitaxel, with a matching placebo used in the control arm.

The study is interventional and randomized, meaning patients are assigned by chance to V940 or placebo on top of the same backbone of Keytruda and chemotherapy. It uses a parallel-arm design with triple blinding, so patients, doctors, and outcome assessors do not know who receives V940, and the main goal is to see whether this treatment approach improves outcomes compared with standard care alone.

The trial is listed as recruiting, with study setup originally submitted on 24 October 2025, marking the formal start of the program from a regulatory and site-activation standpoint. The latest update on 18 February 2026 signals active management of the protocol, but primary and final completion dates are not yet posted, underscoring that key efficacy readouts and top-line data remain several years away.

The update reinforces Moderna's push to expand its mRNA platform beyond vaccines into oncology, in partnership with Merck, which already generates large revenue from Keytruda. A positive outcome could support higher long-term valuation for both MRNA and MRK by opening a new first-line standard for metastatic squamous NSCLC, while also pressuring rival cancer players in immunotherapy and personalized vaccines.

The recruiting status and early-stage nature of the trial mean near-term revenue impact is limited, and sentiment will remain tied to broader mRNA execution and other pipeline news until data emerge. The competitive backdrop includes other immunotherapy combinations and cancer vaccines from large pharma and biotech peers.

Separately, research published in the journal Nature describes personalized mRNA vaccination as feasible in hard-to-treat breast cancer, with end points including feasibility, safety and induction of cancer-mutation-specific immune responses.

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