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Soo Park, MD
Soo Park, MD
Posted: Wednesday, June 19, 2024
Jeffrey S. Weber, MD, PhD, of Perlmutter Cancer Center, NYU Langone Health, and colleagues presented the 3-year update from the mRNA-4157-P201 (KEYNOTE-942) trial during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract LBA9512). The results of this trial, which evaluated the individualized mRNA-based neoantigen therapy mRNA-4157 in patients with stage IIIB to IV cutaneous melanoma, suggest a trend toward improved overall survival when mRNA-4157 is combined with pembrolizumab.
“The current analysis with [approximately] 3 years [of] median follow-up showed durable and meaningful long-term recurrence-free survival and distant metastasis–free survival benefit with mRNA-4157 plus pembrolizumab vs pembrolizumab alone,” concluded the study authors. “Human leukocyte antigen [HLA] and translational subgroup results suggest mRNA-4157 plus pembrolizumab may benefit a broader patient population vs pembrolizumab alone.”
More than 260 patients with completely resected, high-risk, stage IIIB to IV cutaneous melanoma were randomly assigned 2:1 to receive mRNA-4157 plus pembrolizumab or pembrolizumab alone (ClinicalTrials.gov identifier NCT03897881). Study endpoints included investigator-assessed relapse-free survival, safety, and distant metastasis–free survival.
The recurrence-free survival benefit was maintained in the combination arm, with a 49% risk reduction in recurrence and/or death compared with the monotherapy arm (P = .019); the 2.5-year rates of recurrence-free survival were 74.8% and 55.6%, respectively. A clinically meaningful improvement in distant metastasis–free survival was identified among patients given mRNA-4157 plus pembrolizumab compared with those given pembrolizumab alone (P = .0154).
There was a trend toward improved overall survival with mRNA-4157 plus pembrolizumab vs pembrolizumab alone (96.0% vs 90.2%). Recurrence-free survival did not appear to be significantly associated with individual HLA alleles in either treatment arm. Overall, mRNA-4157 demonstrated a safety profile consistent with previous analyses and was well tolerated, with no potentiation of immune-related adverse events.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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