MRNA: Intismeran plus pembrolizumab improved RFS and DMFS in resected melanoma

Moderna's melanoma therapy, intismeran, reduced recurrence risk by 42% in a Phase 3 trial. The combination therapy also improved distant metastasis-free survival. The company reported successful manufacturing and safety profiles. Moderna is exploring the therapy in other cancer types. According to the company, intismeran is designed to stimulate immune responses against tumor-specific mutations.

The iShares Biotechnology ETF (IBB) rose 23.1% through Oct. 23, driven by drug milestones. Merck and Moderna reported positive Phase 3 trial data for intismeran autogene. Roche's Enspryng gained FDA approval for thyroid eye disease. Eli Lilly plans to submit a weight-loss drug for FDA review in early 2027. IBB's expense ratio is 0.44%, while SPDR S&P Biotech ETF (XBI) has a 0.35% expense ratio.

Moderna and Merck's melanoma vaccine trial showed a 42% reduction in tumor recurrence and 38% in distant spread, impressing doctors. However, shares of both companies fell as investors questioned the vaccine's broader potential and commercial success. Analysts raised concerns about costs and competition. The full data will be presented at a medical conference.

Merck and Moderna reported Phase 3 trial results showing their personalized mRNA therapy, combined with Keytruda, reduced melanoma recurrence or death risk by 42% compared to Keytruda alone. The study involved 1,137 patients, with 2-year recurrence-free survival at 82.2% for the combination vs. 70.0% for Keytruda. The therapy is still investigational, and the companies are engaging with regulators.

A phase 3 trial showed intismeran autogene (V940; mRNA-4157) plus pembrolizumab (Keytruda) improved recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in resected stage IIB to IV melanoma. The combination reduced the risk of recurrence or death by 42% (HR, 0.58; P < .001) and distant metastasis or death by 38% (HR, 0.62; P = .002). 24-month RFS rates were 82.2% vs 70.0%, and DMFS rates were 88.5% vs 80.2%.

A Phase III trial showed that intismeran autogene, a personalized mRNA therapy, combined with pembrolizumab, reduced the risk of death or recurrence by 42% in high-risk melanoma patients. The study, presented at ESMO 2026, enrolled 1,137 patients and demonstrated improved recurrence-free and distant metastasis-free survival. Despite the positive clinical results, a data leak caused shares of manufacturers Moderna and Merck to fall.