Merck and Moderna Report 42% Relative Risk Reduction in Melanoma Trial

Merck and Moderna announced detailed Phase 3 results Thursday, Oct. 22, showing their investigational personalized mRNA therapy reduced the relative risk of melanoma recurrence or death when paired with Keytruda.

In the primary intention-to-treat analysis, intismeran autogene plus Keytruda reduced the relative risk by 42% compared with Keytruda alone. The hazard ratio was 0.58, with a 95% confidence interval of 0.45 to 0.75 and a two-sided p-value below 0.001.

The study enrolled 1,137 patients with completely resected stage IIB-IV melanoma, randomized 2-to-1. After a median follow-up of 24.6 months, two-year recurrence-free survival was 82.2% for patients receiving the combination and 70.0% for those receiving Keytruda alone.

Overall-survival data were not mature, and the study remains ongoing. Intismeran autogene is still investigational and is designed using mutations found in an individual patient’s tumor. Merck and Moderna are engaging with regulators.

IBB tracks a modified float-adjusted market-cap-weighted index. It listed a 0.44% expense ratio and 243 holdings as of Oct. 21. Its year-to-date NAV total return was 25.41% as of that date.

The SPDR S&P Biotech ETF (XBI) tracks a modified equal-weighted index designed to provide exposure across large-, mid- and small-cap stocks. It listed a 0.35% gross expense ratio and 165 holdings as of Oct. 22. The funds’ different weighting methods distribute exposure differently, while both retain company-specific clinical risk.