AACR: mRNA-4157 Plus Pembrolizumab Beneficial in Melanoma
17 Apr 2023
VaccineClinical ResultPhase 2AACRmRNA
MONDAY, April 17, 2023 -- For patients with completely resected, high-risk cutaneous melanoma, the novel mRNA-based cancer vaccine (mRNA-4157) combined with pembrolizumab results in improved recurrence-free survival (RFS) compared with pembrolizumab alone, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 14 to 19 in Orlando, Florida.
Adnan Khattak, M.B.B.S., from Hollywood Private Hospital in Nedlands, Australia, and colleagues randomly assigned eligible patients with completely resected, high-risk cutaneous melanoma to receive mRNA-4157 in combination with pembrolizumab or pembrolizumab alone (107 and 50 patients, respectively).
The researchers found that recurrence or death was reported in 22.4 and 40 percent of patients in the combination and monotherapy arms, respectively, at a median follow-up of 101 and 105 weeks. In the combination and monotherapy arms, the 18-month RFS rates were 78.6 and 62.2 percent, respectively. Protocol-defined statistical significance and clinically meaningful improvement in RFS was seen with the combination versus pembrolizumab, with a 44 percent reduction noted in the risk for recurrence or death. The number of patients reporting treatment-related grade 3 or higher adverse events was similar between the arms (25 and 18 percent for combination and monotherapy, respectively); fatigue was the most common mRNA-4157-related grade 3 event.
"Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone," a coauthor said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Moderna and Merck, which are jointly developing and commercializing mRNA-4157/V940.
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Posted April 2023
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