Shots:

• The US FDA has granted the BTD for mRNA-4157/V940, a personalized mRNA cancer vaccine in combination with Merck’s Keytruda for the adjuvant treatment of high-risk melanoma following complete resection
• The designation was based on the P-IIb trial (KEYNOTE-942/mRNA-4157-P201) evaluating mRNA-4157/V940 + Keytruda (200mg, q3w for ~18 cycles) vs Keytruda alone in 157 patients with stage III/IV melanoma which showed a 44% reduction in risk of disease recurrence or death, improvement in the 1EPs of RFS, AEs & safety profile was consistent with prior reported studies, serious TRAEs (14.4% vs 10%)
• The companies will discuss the findings with regulatory authorities, initiate a P-III study in adjuvant melanoma in 2023 & expand to additional tumor types, incl. NSCLC

Ref: Merck | Image: Moderna

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