Merck and Moderna are preparing to file their personalized mRNA melanoma vaccine for FDA approval, STAT reported, as company leaders discussed the program at the STAT Summit in Boston on Oct. 15. The vaccine, intismeran autogene, is given with Merck's immunotherapy Keytruda to patients whose melanoma has been surgically removed but who face a high risk of the cancer returning.
No filing date has been announced. The move follows August results showing the combination significantly delayed cancer recurrence and the spread of melanoma to distant organs in a large Phase 3 trial.
