Incyte, Merck halt Phase III melanoma trial on epacadostat miss
Incyte Corp. (NASDAQ:INCY) and partner Merck & Co. Inc. (NYSE:MRK) said once-daily oral epacadostat plus Merck’s anti-PD-1 mAb Keytruda pembrolizumab missed the primary endpoint in the Phase III ECHO-301/KEYNOTE-252 trial as first-line treatment of unresectable or metastatic melanoma. Incyte's epacadostat is an indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor (see BioCentury, June 16, 2017).
The partners said the trial will be stopped after a DMC review showed that the combo missed the primary endpoint of improving progression-free survival (PFS) vs. Keytruda alone (HR=1). The partners said the second primary endpoint of overall survival (OS) is also "not expected to reach statistical significance” (HR=1.13). Detailed data will be presented at an upcoming scientific meeting. The double-blind, international trial enrolled more than 700 patients...