Moderna and Merck Announce Positive Findings from Personalized Vaccine Study

Moderna and Merck, known as MSD outside of the United States and Canada, released detailed results from a Phase II trial (KEYNOTE-942/mRNA-4157-P201) on April 16, 2023. The trial evaluated mRNA-4157, an investigational messenger RNA (mRNA)-based individualized neoantigen therapy, in combination with Keytruda (pembrolizumab), Merck’s anti programmed cell death protein-1 therapy, in patients with resected high-risk melanoma. According to a company press release, the combination adjuvant treatment reduced the risk of recurrence or death by 44% compared to patients who received traditional pembrolizumab single-therapy treatments.

“Today’s results provide further encouragement for the potential of mRNA as an individualized neoantigen therapy to positively impact patients with high-risk resected melanoma,” said Kyle Holen, senior vice-president and head of Development, Therapeutics and Oncology, Mordena, in the release. “The profound observed reduction in the risk of recurrence-free survival suggests this combination may be a novel means of potentially extending the lives of patients with high-risk melanoma. We look forward to starting the Phase [III] melanoma trial soon and expanding testing to lung cancer and beyond.”

“Data from KEYNOTE-942 provide evidence for the potential of mRNA-4157 (V940) in combination with [Keytruda] to improve recurrence-free survival when given to patients with resected high-risk melanoma,” said Eliav Barr, senior vice-president, head of Global Clinical Development, and chief medical officer, Merck Research Laboratories, in the release. “These data support the potential of mRNA-4157 (V940) in combination with [pembrolizumab] to help fight melanoma earlier and warrant investigation of the combination in a larger Phase [III] trial. We also look forward to studying mRNA-4157 (V940) and [pembrolizumab] in a variety of other early-stage cancers.”

According to the release, based on this data, FDA and the European Medicines Agency have granted the treatment breakthrough therapy designation and priority medicines scheme status, respectively. The companies plans to release further data at an undisclosed medical meeting, and publish it in a peer-reviewed publication.

Source: Merck