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2023-04-17| Trials & Approvals

Moderna’s Cancer Vaccine to Enter Phase 3 Trials This Year

by Reed Slater
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Along with promising data from its Phase 2b trial studying the safety and efficacy of its personalized cancer vaccine in high-risk melanoma patients, Moderna and Merck, which are jointly developing and commercializing the vaccine, mRNA-4157 (V940), would enter Phase 3 trials by the end of the year.

Promising Phase 2b Data

Moderna and Merck released some results from the Phase 2b KEYNOTE-942 trial during the 2023 American Association for Cancer Research (AACR) annual meeting. The trial compared mRNA-4157 in combination with Keytruda with Keytruda alone in patients with resected high-risk stage III or IV melanoma. 

In the 157-patient trial, mRNA-4157, in combination with Keytruda, demonstrated a 44% reduction in recurrence or death compared to Keytruda as a standalone therapy. At the 18-month mark, the combination therapy’s recurrence-free survival (RFS) rate was 78.6% compared to 62.2% in the control arm.

Personalized cancer vaccines are one of the most promising prospects throughout the biotech industry, and Merck and Moderna are at the forefront of cutting-edge technology with mRNA-4157. The companies designed the vaccine to prime a patient’s immune system to generate an antitumor response in conjunction with another therapy. In mRNA-4157’s case, Moderna and Merck are using Keytruda as the partnered therapy.

Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, said, “These data support the potential of mRNA-4157 (V940) in combination with KEYTRUDA to help fight melanoma earlier and warrant investigation of the combination in a larger Phase 3 trial. We also look forward to studying mRNA-4157 (V940) and KEYTRUDA in a variety of other early-stage cancers.”

Related Article: Moderna’s mRNA Flu Vaccine Development Slow Going as Data Rolls In

Cancer Vaccine Moving Forward

With Moderna and Merck’s mRNA-4157 gaining momentum, the revolutionary new cancer therapy could open avenues to other immuno-oncology applications. As the Phase 2b trial starts to wrap up and Moderna and Merck look forward to a Phase 3 trial in melanoma treatment, the companies are also looking in other directions, like lung cancer treatment. 

Moderna’s senior vice president and head of development of therapeutics and oncology, Dr. Kyle Holen, said, “The profound observed reduction in the risk of recurrence-free survival suggests this combination may be a novel means of potentially extending the lives of patients with high-risk melanoma. We look forward to starting the Phase 3 melanoma trial soon and expanding testing to lung cancer and beyond.”

Due to the KEYNOTE-942 trial’s success so far, the FDA granted mRNA-4157 Breakthrough Therapy Designation, and the EMA granted the personalized cancer vaccine Priority Medicines (PRIME) scheme designation. 

As mRNA technology advances rapidly, Moderna remains at the forefront of the revolution, pushing the envelope for what the technology can do. The remainder of 2023 will be an exciting year to keep up with the massive developments in mRNA technology and, more specifically, its applications in immuno-oncology. 

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