国泰海通证券研究·2026-02-01 14:04Core Viewpoint - The 5-year follow-up results of Moderna's personalized mRNA cancer vaccine V940 in high-risk melanoma support the vaccine's mechanism to provide durable immune responses, providing a stronger clinical basis for subsequent Phase III and registration advancements [1][2]. Group 1: Clinical Results - On January 21, 2026, Moderna and Merck announced the 5-year follow-up results of the Phase IIb study of V940 (mRNA-4157) combined with Keytruda for adjuvant treatment of high-risk melanoma, demonstrating sustained efficacy over a long period [2]. - The KEYNOTE-942 study results indicate that the combination of V940 and Keytruda reduces the risk of recurrence or death in high-risk melanoma patients by 49%, maintaining this efficacy from 2 years (44%) to 3 years (49%) and remaining at 49% at the 5-year follow-up [2]. - No new safety signals were observed during the study, indicating a favorable safety profile for the treatment [2]. Group 2: Development Progress - V940 is advancing ahead of similar projects, with 8 ongoing Phase II/III clinical studies covering various solid tumors, including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma [2]. - The Phase III clinical trial for melanoma has completed enrollment and is expected to yield critical data in 2026; the project has also received FDA breakthrough therapy designation, providing regulatory support for future registration applications [2]. Group 3: Technological Validation - The data readout provides evidence for the transition of mRNA tumor vaccines from concept validation to pathway validation, with mRNA-4157 being a personalized neoantigen therapy capable of encoding up to 34 neoantigens [3]. - The therapy activates T-cell responses with immune memory characteristics and complements PD-1 inhibitors, showing that efficacy does not significantly diminish over time, distinguishing it from previous unsuccessful attempts at tumor vaccines [3].