Merck and Moderna: Phase 3 INTerpath-001 of intismeran plus Keytruda meets RFS and DMFS endpoints in melanoma

Moderna/Intismeran autogene (mRNA-4157/V940)

Merck and Moderna said their Phase 3 INTerpath-001 trial met its main goals: adding intismeran autogene, an mRNA cancer vaccine built for each patient's own tumour, to Keytruda significantly improved recurrence-free survival and distant-metastasis-free survival versus Keytruda alone. Patients had melanoma that had been completely removed by surgery but was at high risk of returning.

• 1,137 patients with resected stage IIB–IV melanoma, randomised 2:1, treated for about 56 weeks.
• How it works: tumour DNA is sequenced, and the vaccine encodes that tumour's unique mutations so the immune system learns to hunt them; Keytruda releases the brakes on those immune cells.
• No hazard ratios yet; data will be shown at a medical meeting. The Phase 2b predecessor had cut recurrence or death by 49%.
• Overall survival is still being followed; the companies will discuss filings with regulators. No new safety signals.