Rahway, New Jersey, and Cambridge, Massachusetts, August 19, 2026

Merck and Moderna announced positive topline results from the Phase 3 INTerpath-001 trial evaluating intismeran autogene (V940/mRNA-4157) plus KEYTRUDA (pembrolizumab) as adjuvant treatment for patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival (RFS) and key secondary endpoint of distant metastasis-free survival (DMFS), with the combination demonstrating statistically significant and clinically meaningful improvements compared with KEYTRUDA alone. The companies said the results represent the first positive Phase 3 readout for an individualized neoantigen therapy and an mRNA-based cancer therapy, strengthening the clinical development case for personalized immunotherapy in melanoma.

INTerpath-001 Demonstrates Significant Clinical Benefit

The INTerpath-001 Phase 3 study evaluated intismeran autogene in combination with KEYTRUDA versus KEYTRUDA alone following complete surgical resection in patients with high-risk stage IIB, IIC, III or IV cutaneous melanoma. The global randomized, double-blind study enrolled 1,137 patients, who were assigned in a 2:1 ratio to receive the combination or KEYTRUDA alone. At a prespecified interim analysis, the combination achieved the study’s RFS primary endpoint and DMFS key secondary endpoint, supporting further development of the individualized neoantigen approach. The study will continue to evaluate additional endpoints, including overall survival, while Merck and Moderna plan to present detailed findings at an upcoming international medical meeting and engage with regulatory authorities regarding potential filing submissions

Personalized mRNA Therapy Builds on Earlier Melanoma Data

Intismeran autogene is an investigational mRNA-based individualized neoantigen therapy designed specifically for each patient’s tumor. The therapy uses the unique mutational profile of a patient’s cancer to encode up to 34 neoantigens, with the goal of training and activating the immune system to recognize and attack tumor cells. The Phase 3 findings build on earlier evidence from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study. At five-year follow-up presented at ASCO 2026, intismeran autogene plus KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared with KEYTRUDA alone. These earlier findings provided longer-term clinical support for advancing the personalized mRNA approach into Phase 3 development.

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Merck and Moderna Expand Individualized Oncology Pipeline

The positive Phase 3 readout strengthens the broader INTerpath development program, which is evaluating intismeran autogene with KEYTRUDA and other anticancer therapies across multiple tumor types and treatment settings. The program currently includes nine Phase 2 and Phase 3 studies covering melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma. The companies are also investigating individualized neoantigen therapy in earlier-stage and metastatic disease settings. For Merck and Moderna, the latest melanoma results provide an important clinical validation of their strategy to combine personalized tumor-specific mRNA technology with immune checkpoint inhibition, while upcoming regulatory discussions and additional clinical readouts will determine the next steps toward potential commercialization.

Source:Merck press relese