By VETTAPHARMA reporter: Moderna, Inc. and Merck & Co., Inc. have released median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study showing continued improvement in recurrence-free survival (RFS) for patients with high-risk Stage III/IV melanoma who received the investigational personalized cancer vaccine intismeran autogene combined with KEYTRUDA® (pembrolizumab), compared with KEYTRUDA alone.
In this pre-planned analysis of the adjuvant trial involving patient’s post-complete surgical resection, treatment with the combination resulted in a 49 % reduction in the risk of recurrence or death (hazard ratio = 0.510; 95 % CI, 0.294–0.887; one-sided nominal p = 0.0075) relative to pembrolizumab monotherapy. These results build on earlier analyses at two and three years, indicating that the vaccine’s benefit persists over a longer term.
According to company statements, intismeran autogene (also called mRNA-4157 or V940) is an individualized neoantigen therapy designed and manufactured based on each patient’s tumor DNA profile to stimulate targeted immune responses. When used with KEYTRUDA — an anti-PD-1 immunotherapy — the goal is to deepen and extend immune-mediated cancer control in patients at high risk for recurrence following surgery.
Moderna’s Senior Vice President and Head of Development, Oncology and Therapeutics, Kyle Holen, M.D., noted that the five-year results “highlight the potential of a prolonged benefit” from the vaccine + KEYTRUDA combination in resected high-risk melanoma. Both companies plan to present additional follow-up data at an upcoming medical conference.
The announcement also confirmed ongoing expansion of the clinical program, with eight Phase 2 and Phase 3 trials testing the vaccine + KEYTRUDA in multiple tumor types — including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma — aiming to evaluate broader applications of the therapy.
Source credit:
- Merck & Co., Inc. (2026, January 20). Moderna & Merck announce 5-year data for intismeran autogene in combination with KEYTRUDA® (pembrolizumab) demonstrated sustained improvement in the primary endpoint of recurrence-free survival in patients with high-risk Stage III/IV melanoma following complete resection [Press release]. Merck. Click here
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