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Novel Cancer Vaccine Prevents Melanoma From Returning in First for mRNA
On Wednesday, Moderna and Merck announced their personalized mRNA vaccine intismeran combined with Keytruda met primary and secondary endpoints in a Phase 3 trial of 1,137 high-risk melanoma patients.
Designed to target unique mutations in each patient's tumor, intismeran trains the immune system to identify and destroy remaining cancer cells as an adjuvant therapy administered after surgery.
Shares of Moderna surged 93% on Wednesday after the vaccine-plus-Keytruda combination demonstrated superior efficacy in preventing melanoma recurrence and spread compared with Keytruda alone in the late-stage study.
Merck and Moderna plan to present detailed trial results at an upcoming medical meeting and share findings with regulators, having already secured an expedited review pathway from the FDA and European Medicines Agency.
Manufacturing each personalized dose takes six weeks, while companies explore this mRNA approach across nine additional Phase 2 and Phase 3 trials spanning melanoma, lung, bladder, kidney, pancreatic and gastric cancers.
Custom therapy, combined with immunotherapy, is based on mRNA technology, which consists of instructing body cells to make proteins capable of triggering an immune response.