Moderna and Merck are preparing to seek FDA approval for intismeran autogene, a personalized mRNA vaccine for patients with high-risk melanoma that has been surgically removed. It is intended for use with Merck’s immunotherapy drug Keytruda.
The planned filing follows positive Phase 3 results announced in August. The combination significantly delayed cancer recurrence.
No filing date has been announced. The companies plan to present the full late-stage trial data at the ESMO Congress on October 24. The filing could bring Moderna’s mRNA-based cancer treatment closer to commercialization.