Merck and Moderna's mRNA Cancer Vaccine Shows Promising Results in Phase 3 Trial

Two major pharmaceutical companies, Merck and Moderna, have announced positive top-line results from a global Phase 3 trial of their jointly developed mRNA-based personalized neoantigen therapy, intismeran autogene (mRNA-4157/V940). The treatment, combined with Merck's flagship immune checkpoint inhibitor Keytruda (pembrolizumab), demonstrated statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival compared to Keytruda alone. This marks the first time a personalized neoantigen therapy and an mRNA-based cancer treatment has produced successful results in a Phase 3 trial.

The Phase 3 trial enrolled 1,137 high-risk resected melanoma patients with no prior systemic therapy. The combination therapy reduced the risk of recurrence or death by 49 percent (HR=0.51) and the risk of distant metastasis or death by 59 percent (HR=0.411) compared to Keytruda alone. Georgina Long, a professor at the Melanoma Institute Australia, called it 'the first Phase 3 trial to show that the combination of intismeran, designed around each patient's unique tumor mutational fingerprint, and pembrolizumab can reduce the risk of recurrence and death.'

Moderna CEO Stéphane Bancel said creating an mRNA treatment tailored to each individual patient's cancer 'has been a dream for years, and now it has become a reality.' The two companies plan to continue evaluating additional secondary endpoints, including overall survival (OS), in line with the clinical protocol.

In related news, South Korean biotech company Samyang Biopharm announced that its proprietary gene delivery platform NanoReady had been selected as a cover paper in the Journal of Controlled Release. The NanoReady platform is designed to selectively deliver mRNA to dendritic cells in the spleen, which play a central role in immune function.