Jeffrey Weber, MD, PhD, NYU Langone Health, New York, NY, discusses the Phase II mRNA-4157-P201 (KEYNOTE-942) trial (NCT03897881), which evaluates mRNA-4157, a novel mRNA-based individualized neoantigen therapy, combined with pembrolizumab for treating completely resected high-risk stage IIIB-IV cutaneous melanoma. The primary analysis showed significant benefits in recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) compared to pembrolizumab alone. With nearly three years of median follow-up, the combination therapy maintained a 49% risk reduction in recurrence and/or death and showed a clinically meaningful improvement in DMFS. The 2.5-year RFS rate was 74.8% for the combination therapy versus 55.6% for pembrolizumab alone, with a trend towards improved overall survival. Subgroup analyses indicated that the combination therapy benefits a broader patient population, including various tumor mutational burden and PD-L1 expression levels. mRNA-4157 was well tolerated, with a safety profile consistent with previous analyses. This interview took place during the 2024 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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