mRNA Vaccine, Plus Pembrolizumab, Minimizes Recurrence Rate in Melanoma

Source: Oncology Nursing News, April 2023

The personalized mRNA-based cancer vaccine mRNA-4157 (V940) plus pembrolizumab (Keytruda) demonstrated efficacy in the adjuvant setting for patients with resected high-risk melanoma. Findings from the open-label, randomized, phase 2b mRNA-4157-P201/KEYNOTE-942 trial (NCT03897881), showed that the combination improved recurrence-free survival (RFS) compared with pembrolizumab alone, regardless of tumor mutational burden (TMB).

The findings, which were presented during the 2023 AACR Annual Meeting, showed that the overall 18-month RFS rate was 78.6% (95% CI, 69.0%-85.6%) with the combination vs 62.2% (95% CI, 46.9%-74.3%) with pembrolizumab alone, leading to a 44% reduction in the risk of disease recurrence or death (HR, 0.561; 95% CI, 0.309-1.017; 1-sided P = .0266). These data, which were presented in a press briefing by senior author Jeffrey S. Weber, MD, PhD, were found to be statistically significant and clinically meaningful.

“For the first time in a randomized study with a control arm, the addition of an mRNA neoantigen vaccine appeared to augment the benefit of PD-1 blockade, without adding significant high-grade toxicity,” Weber, who is deputy director of the NYU Langone Perlmutter Cancer Center and Laura and Isaac Perlmutter Professor of Oncology at NYU Grossman School of Medicine, in New York, New York, as well as a 2016 Giant of Cancer Care® winner in melanoma, stated in a press release.2 “This study is extraordinarily important, because it gives hope that this novel strategy will provide clinical benefit.”