$250 Million Gains Merck Access to Personalized Cancer Vaccines

Moderna, Inc. and New Jersey-based Merck today announced that Merck had exercised its option to jointly develop and commercialize the personalized cancer vaccine mRNA-4157/V940.

mRNA-4157/V940 is currently being evaluated in a Phase 2 clinical trial (KEYNOTE-942) in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma.

Under the agreement, initially established in 2016 and amended in 2018, Merck will pay Moderna $250 million to exercise its option for personalized cancer vaccines, including mRNA-4157/V940, and will collaborate on development and commercialization.

"This long-term collaboration combining Merck's expertise in immuno-oncology with Moderna's pioneering mRNA technology has yielded a novel tailored vaccine approach," said Dr. Eliav Barr, SVP and head of global clinical development, chief medical officer, Merck Research Laboratories, in a related press release issued on October 12, 2022.

KEYNOTE-942 is an ongoing randomized, open-label Phase 2 trial that enrolled 157 patients with high-risk melanoma.

Following complete surgical resection, patients were randomized to mRNA-4157/V940 (9 doses every three weeks) and KEYTRUDA (200 mg every three weeks) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity. KEYTRUDA was selected as the comparator in the trial because it is considered a standard of care for high-risk melanoma patients.

The primary endpoint is recurrence-free survival, and secondary endpoints include distant metastasis-free survival and overall survival.

The Phase 2 trial is fully enrolled,d and primary data are expected in the fourth quarter of 2022.