Merck and Moderna released INTerpath-001 results Thursday, Oct. 22, showing patients given intismeran autogene with Keytruda had a 42% lower relative risk of melanoma recurrence or death.
In the trial’s primary intention-to-treat analysis, the hazard ratio for the combination versus Keytruda alone was 0.58 (95% confidence interval, 0.45 to 0.75; two-sided p-value below 0.001).
The study included 1,137 patients whose stage IIB-IV melanoma had been completely removed by surgery. Participants were assigned in a 2-to-1 ratio to receive the combination or Keytruda alone.
At the 24.6-month median follow-up point, estimated two-year recurrence-free survival was 82.2% in the combination group and 70.0% in the Keytruda-only group.
Intismeran autogene remains an investigational mRNA treatment tailored to mutations identified in each patient’s tumor.
Overall-survival results are not yet mature. The ongoing study will continue to assess survival, and Merck and Moderna said they are engaging with regulators.
Some trial data surfaced before the companies released their full results, the Associated Press reported. The AP said the findings were scheduled for presentation in Madrid on Saturday, Oct. 24. EconoTimes previously covered Moderna’s share decline after the findings surfaced early.
