Moderna's mRNA Cancer Vaccine Cuts Melanoma Recurrence in Landmark Phase 3 Trial

Moderna and Merck said their personalized mRNA cancer vaccine combined with Keytruda met its goals in a large melanoma trial, sending Moderna shares up more than 160%.

Moderna and Merck said Wednesday that their personalized mRNA cancer vaccine, combined with the immunotherapy drug Keytruda, succeeded in a late-stage Phase 3 trial for melanoma, the deadliest form of skin cancer, sending Moderna shares up more than 160%.

The trial enrolled 1,137 patients whose high-risk melanoma had been surgically removed, randomizing them to receive either Keytruda plus the tailored vaccine or Keytruda alone. Interim results showed the treatment — called intismeran, also known as mRNA-4157 — met both its primary goal of preventing the cancer from returning and its secondary goal of stopping it from spreading to other parts of the body.

The vaccine uses the same mRNA platform as Moderna's COVID-19 shot, but is individually designed to encode up to 34 mutations unique to each patient's tumor. Five-year data from an earlier mid-stage trial showed a 49% reduction in the risk of recurrence or death. Moderna's CEO Stéphane Bancel called the results “as big a day for humanity as Nov. 16, 2020,” and the companies say they aim to file for regulatory approval within months.

Sources: CNN | Ars Technica