FDA Breakthrough designation formRNA-4157/V940, + Keytruda for the adjuvant treatment of patients with high-risk melanoma following complete resection
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Merck Inc., known as MSD outside of the United States and Canada, announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Breakthrough Therapy Designation by the FDA for the adjuvant treatment of patients with high-risk melanoma following complete resection
The FDA granted Breakthrough Therapy Designation based on positive data from the Phase II2b KEYNOTE-942/mRNA-4157-P201 trial.
The FDA’s Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.
The Phase IIb KEYNOTE-942/mRNA-4157-P201 trial of mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda, Merck's anti-PD-1 therapy, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of recurrence-free survival (RFS) versus Keytruda alone for the adjuvant treatment of patients with stage III/IV melanoma following complete resection. Adjuvant treatment with mRNA-4157/V940 in combination with Keytruda reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.31-1.08]; one-sided p-value=0.0266) compared with Keytruda alone.
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