Moderna and Merck look to Phase 3 trial for cancer vaccine and Keytruda treatment

Following the initial announcement of positive Phase 2b KEYNOTE-942 trial results in December 2022​, the companies have this week released further data from the trial as they look to the next steps of development.

A Phase 3 study is expected to get underway this year, while the companies will also ‘rapidly expand’ development to additional tumor types, including non-small cell lung cancer.

Detailed data provides ‘further encouragement’

The personalized cancer vaccine, mRNA-4157, is the most advanced candidate in Moderna’s cancer vaccine portfolio and is being jointly developed with Merck.

The investigational individualized neoantigen therapy (INT) is being trialed with Merck’s blockbuster anti-PD-1 therapy, Keytruda, in patients with resected high-risk melanoma (stage III/IV).

The US Food and Drug Administration and European Medicines Agency have granted the combination Breakthrough Therapy Designation and the PRIME scheme, respectively, for mRNA-4157 (V940) in combination with Keytruda for the adjuvant treatment of patients with high-risk melanoma following complete resection. 

Detailed data from the Phase 2b trial is being presented during the American Association for Cancer Research (AACR) Annual Meeting this week.

“These results provide further encouragement for the potential of mRNA as an individualized neoantigen therapy to positively impact patients with high-risk resected melanoma,” said Dr. Kyle Holen, M.D. Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology.

“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.”

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