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Moderna & Merck Announce 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in the Primary Endpoint of Recurrence-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection
At a median five-year pre-planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone ...
About this update from Merck & Company, Inc.
[{"type":"text","content":"At a median five-year pre-planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone","length":250,"tagName":"p"},{"type":"text","content":"The Companies plan to present further data from follow up analyses of the study's primary and secondary endpoints at a future medical conference","length":148,"tagName":"p"},{"type":"text","content":"Eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma","length":166,"tagName":"p"},{"type":"text","content":"CAMBRIDGE, MA AND RAHWAY, NJ / ACCESS Newswire / January 20, 2026 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage III/IV) following complete resection. In this pre-planned analysis, adjuvant treatment with intismeran autogene in combination with KEYTRUDA continued to demonstrate sustained and clinically meaningful improvement in the study's primary endpoint, recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294-0.887]; one-sided nominal p=0.0075) compared to KEYTRUDA alone. Moderna and Merck plan to present further data from follow up analyses of primary and secondary endpoints at an upcoming medical meeting.","length":1074,"tagName":"p"},{"type":"text","content":""Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Oncology and Therapeutics. "We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNA's potential in cancer care. We look forward to several...