Merck & Co Inc. (NYSE:MRK) and Moderna Inc. (NASDAQ:MRNA) stocks are surging higher on Wednesday after the companies shared topline data from individualized cancer therapy for advanced skin cancer.
The company released positive topline results from the Phase 3 INTerpath-001 trial of adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157) in combination with Keytruda (pembrolizumab), in patients with completely resected stage IIB-IV melanoma.
Intismeran autogene is an mRNA-based individualized neoantigen therapy (INT) designed specifically for each patient based on the unique set of mutations within their tumor to train and activate the immune system to recognize and fight cancer.
Trial Meets Key Endpoints
At a pre-planned interim analysis, the investigational combination delivered statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to standard Keytruda alone.
Safety profiles matched previous study results without generating new safety signals.
First Phase 3 Win for mRNA Cancer Therapy
The readout represents the first positive Phase 3 result for an individualized neoantigen therapy and an mRNA-based cancer treatment.
Additionally, it is the first Phase 3 trial demonstrating a clinically meaningful improvement over Keytruda monotherapy in the adjuvant setting for resected melanoma.
Researchers will continue the ongoing study to track secondary metrics, including overall survival.
Merck and Moderna are advancing the broader INTerpath clinical program, which includes nine Phase 2 and Phase 3 trials across melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma, plus Phase 1 trials in pancreatic, gastric, and lung cancers.
Building On Prior Clinical Results
The latest data reinforces earlier Phase 2b KEYNOTE-942 trial findings shared at the 2026 ASCO Annual Meeting.
Five-year follow-up metrics indicated the combination lowered the risk of recurrence or death by 49% and reduced distant metastasis or death risk by 59% compared to Keytruda alone.
Price Action: Merck & Co shares were up 6.18% at $143.53, and Moderna shares were up 56.21% at $98.35 during premarket trading on Wednesday, according to Benzinga Pro data.
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