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Moderna and Merck Advance mRNA Cancer Vaccine Trial in First-Line Lung Cancer: What Investors Should Watch

Tipranks - Sat Feb 21, 10:44AM CST

Moderna (MRNA) announced an update on their ongoing clinical study.

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The Phase 2 study “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)” tests whether adding Moderna’s V940 to standard lung cancer therapy improves survival in advanced disease. It targets patients with metastatic squamous non-small cell lung cancer who have not received prior treatment and could shape the next wave of personalized cancer care.

The trial 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.

For investors, this 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.

Conversely, 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, so investors should view this study as a high-upside but binary event that could influence strategic positioning in the oncology space.

The INTerpath-013 trial is actively ongoing and recently updated, with more detailed information and future results to be made available through the ClinicalTrials.gov portal.

To learn more about MRNA’s potential, visit the Moderna drug pipeline page.

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