Moderna (NASDAQ: MRNA) and Merck (NYSE: MRK) report pivotal melanoma-vaccine benefit
Personalised vaccination added to Keytruda reduced recurrence or death after surgery in the Phase 3 study.
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Moderna and Merck's personalised cancer vaccine intismeran produced a positive Phase 3 result in patients with high-risk melanoma following surgery. In INTerpath-001, combining the vaccine with Keytruda reduced the hazard of recurrence or death by 42% compared with Keytruda alone.
At two years, recurrence-free survival was 82.2% with the combination and 70% with Keytruda. Distant metastasis-free survival was also higher, at 88.5% versus 80.2%.
The distinction between endpoints matters. A reduction in recurrence or death is not the same as a demonstrated reduction in mortality alone. Overall-survival follow-up will help establish the longer-term clinical picture.
The result strengthens the development case for individualised cancer vaccination and gives Moderna a major oncology milestone. Commercial translation will also require regulatory review, reliable personalised manufacturing and workable treatment timelines. The data move the programme forward substantially without resolving all the practical questions involved in delivering a patient-specific medicine at scale.
Source: Fierce Biotech reporting on the Phase 3 results, 24 October.