Overview
- The companies said Wednesday that the Phase 3 trial of intismeran plus pembrolizumab met its primary endpoint of recurrence‑free survival and a key secondary endpoint of distant metastasis‑free survival versus pembrolizumab alone.
- The study enrolled about 1,137 patients with completely resected stage IIB–IV melanoma who were randomized to receive Keytruda with or without the individualized mRNA vaccine.
- Moderna and Merck released topline, interim results but have not published detailed hazard ratios, stage‑specific analyses, landmark rates, safety tables or overall‑survival outcomes, and they plan to present full data at a medical meeting and engage regulators.
- The vaccine is bespoke: teams sequence a patient’s tumor and blood, select multiple neoantigens by algorithm, then manufacture a tailored mRNA dose in roughly six weeks, raising questions about scale, cost and logistics for wider use.
- Investors reacted strongly with Moderna shares surging and Merck shares rising, and the partners are already testing intismeran in multiple other Phase 2 and Phase 3 trials across different cancers.