Moderna's shares soared as much as 83% in premarket trading in New York after its personalized cancer vaccine, developed in collaboration with Merck & Co., reduced the risk of melanoma returning in a large, late-stage trial. The result marks the first positive Phase 3 trial for a personalized cancer vaccine by any company.
The study met its primary endpoint by showing that the cancer vaccine, called intismeran autogene, combined with Merck's blockbuster immunotherapy Keytruda, improved recurrence-free survival compared with Keytruda alone. The study also met a secondary endpoint by reducing the risk of cancer spreading to other parts of the body.
Professor Georgina Long, the study's principal investigator, medical director of Melanoma Institute Australia, and chair of Melanoma Medical Oncology and Translational Research at the University of Sydney, wrote in a statement:
Today's results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational 'fingerprint' of a patient's own tumor, given in combination with pembrolizumab, can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared with KEYTRUDA alone.
Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer.
Moderna and Merck did not disclose exact figures showing how much the therapy improved r
