Moderna, Inc. and Merck announced that Merck has exercised its option to jointly develop and commercialize personalized cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement. Personalized cancer vaccines are created to prime the immune system so that a patient can generate a tailored antitumor response to their tumor mutation signature to treat their cancer.

The novel mRNA-4157/V940 is currently being assessed in combination with Keytruda, Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a phase II clinical trial being conducted by Moderna. mRNA-4157/V940 is designed to stimulate an immune response by generating T-cell responses based on the mutational signature of a patient’s tumor.

KEYNOTE-942 is an ongoing randomized, open-label phase II trial that enrolled 157 patients with high-risk melanoma. Following complete surgical resection, patients were randomized to mRNA-4157/V940 (nine doses every 3 weeks) and Keytruda (200 mg every 3 weeks) versus Keytruda alone for approximately 1 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 II trial is fully enrolled and primary data are expected in the fourth quarter of 2022.

Stephen Hoge, MD, president of Moderna, stated, “We have been collaborating with Merck on PCVs since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalized cancer treatment used in combination with Keytruda. With data expected this quarter on PCV, we continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer. Continuing our strategic alliance with Merck is an important milestone as we continue to grow our mRNA platform with promising clinical programs in multiple therapeutic areas.”

“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, senior VP and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with our colleagues at Moderna to advance mRNA-4157/V940 in combination with Keytruda as it aligns with our strategy to impact early-stage disease.”

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