Randomized phase 2b study of intismeran autogene plus pembrolizumab versus pembrolizumab in resected melanoma: 3-year update

Primary analysis of the multinational phase 2b KEYNOTE-942 trial demonstrated prolonged recurrence-free survival (RFS) and distant metastatis-free survival (DMFS) with the individualize neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab versus pembrolizumab alone in high-risk (stage IIIB-IV) resected melanoma. Three-year update results of the trial have now been published. Median follow-up was 34.9 months (range 25.1-51.0). The combination continued to demonstrate improvement in RFS (HR 0.510; 80% CI 0.351-0.743) and DMFS (0.384; 0.227-0.65) compared with pembrolizumab alone. An early preliminary trend in overall survival favored the combination versus pembrolizumab alone (HR 0.425; 80% CI 0.170-1.004). The safety profile was consistent with earlier findings; most adverse events were low-grade with no grade 4-5 events related to intismeran. The authors conclude that intismeran plus pembrolizumab significantly prolongs RFS and DMFS compared with pembrolizumab alone for the adjuvant treatment of resected high-risk melanoma.