Novel Cancer Vaccine Prevents Melanoma From Returning in First for mRNA
The combination also lowered the risk of melanoma spreading, and the companies said the treatment was generally well tolerated in 1,137 patients.
- 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.
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What it was like to go through a trial that could revolutionize cancer treatment
After Mark Orwig had a melanoma tumor removed from his cheek in 2023, he began to worry about the future. The smallest remnants of the deadly skin cancer can linger in the body after a successful surgery, eventually causing the…
Merck and Moderna's individualised mRNA melanoma vaccine just won a Phase 3 trial outright — 1,137 patients, randomised two-to-one, both the primary and key secondary endpoint met — and the companies still won't say by how much until a medical conference decides when
Merck and Moderna have announced that a personalised mRNA melanoma vaccine, developed and tested individually for each patient in the trial, has succeeded in the first Phase 3 trial run for a therapy of its kind. The trial, called INTerpath-001, met its primary endpoint and a key secondary endpoint outright. What the companies have not yet said is by how much. We are not doctors or clinical researchers, and nothing here should be read as advice …
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