Incyte and Merck are set to end the ECHO-301/KEYNOTE-252 study, a Phase III trial evaluating Incyte’s epacadostat in combination with Merck’s Keytruda to treat patients with unresectable or metastatic melanoma.
The decision is based on a review conducted by an external Data Monitoring Committee (EDMC ) that found the trial did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.
The review also found the trial’s second primary endpoint of overall survival is not expected to reach statistical significance.
Incyte and Merck will convey these results to trial investigators and will work with them to appropriately conclude the study.
Findings from ECHO-301/KEYNOTE-252 study are expected to be evaluated and submitted for presentation at an upcoming scientific congress.
Incyte chief medical officer Steven Stein said: “While we are disappointed that this study did not confirm the efficacy of epacadostat in combination with Keytrudain patients with unresectable or metastatic melanoma, data from ECHO-301/KEYNOTE-252, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of IDO1 inhibition in combination with PD-1 antagonists, and may inform our broader epacadostat clinical development programme.
“We remain dedicated to transforming the treatment of cancer and will continue to explore how IDO1 inhibition and other novel mechanisms can potentially improve outcomes for patients in need.”
The randomised, double-blind, placebo-controlled study enrolled more than 700 patients with unresectable or metastatic melanoma.
The trial’s dual primary endpoints included progression-free survival and overall survival.
It major secondary endpoints were objective response rate, safety and tolerability.