The full Phase 3 INTerpath-001 presentation at ESMO on October 24 confirmed the figures Merck and Moderna released on October 22: intismeran autogene, a vaccine built from up to 34 neoantigens selected from each patient’s own tumour, plus Keytruda cut the risk of recurrence or death by 42 percent against Keytruda alone in completely resected stage IIB to IV melanoma (hazard ratio 0.58, 95 percent confidence interval 0.45 to 0.75), and cut the risk of distant metastasis or death by 38 percent (hazard ratio 0.62). At two years, 82.2 percent of combination patients remained recurrence-free against 70.0 percent on Keytruda alone. A prespecified sensitivity analysis excluding patients who never received a dose as planned showed a 49 percent reduction in recurrence risk, and after the six-month immunisation period the reduction was 58 percent. Overall survival is not yet mature, with a favourable trend reported, and no new safety signals were seen. The results have been accepted for publication in The New England Journal of Medicine.
What changed over the weekend is the argument around the data, not the data. Endpoints News, reporting from a packed Madrid presentation on October 25, described the result as a triumph of science and the start of the harder work. Clinicians quoted across the weekend’s coverage were emphatic, while independent experts were more measured: Alan Melcher of the Institute of Cancer Research in London called the results very impressive and warned against assuming one melanoma trial predicts success across cancers, with longer follow-up needed on survival.
The market reaction carries the same split. Reuters reported on October 22 that Moderna shares, which had nearly quadrupled since the August topline announcement, closed more than 17 percent lower on the day the detailed data appeared, and Merck fell about 1.8 percent. RBC analyst Trung Huynh described the result as clinically meaningful and likely to support approval, but at the low end of investor expectations, noting the earlier Phase 2 trial had shown roughly a 49 percent reduction at five years in a narrower, higher-risk population.
Moderna chief executive Stephane Bancel’s position, in interviews around the data, is that the companies are preparing a United States filing and expect a launch in 2027, and that the approach should add benefit wherever Keytruda works, with trials running in kidney, bladder and lung cancer and early pancreatic data presented on October 25. Against that sit two unresolved economics: manufacturing takes roughly six weeks per patient, and no price has been disclosed. STAT’s follow-on interview with Bancel, published October 26, continues that next-steps discussion. The filing, the price and the first non-melanoma data are the three dated tests of the platform claim.