RE:mRNA vaccine company Phase 2 trial fails on wrong biomarker May 03, 2024 - Moderna has combined its mRNA vaccine with Merck's (MSD) immune checkpoint inhibitor Keytruda for the treatment of cancer.
"Moderna’s foray into cancer is led by mRNA-4157’s use in patients with high-risk melanoma and non-small cell lung cancer on top of Keytruda. Since the start of the year, Moderna has seemingly coalesced around submitting the therapy for accelerated approval as a melanoma treatment. That’s contingent on substantially enrolling the phase 3 melanoma study, which would serve as the confirmatory trial, and building up manufacturing capacity at a Marlborough, Massachusetts site.
“We're optimistic that both [enrollment] and the facility will be available in short order,” Moderna President and R&D chief Stephen Hoge, M.D. told investors. He noted that Moderna has yet to engage regulators on using the accelerated pathway, waiting until it has “crossed [its] own threshold.”
“Our view is that if we're able to get to the point where accelerated approval is appropriate, and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now,” Hoge said."
https://www.fiercebiotech.com/biotech/moderna-plants-new-solid-tumor-trials-culls-checkpoint-inhibitor