Incyte Corp. and Merck said an external Data Monitoring Committee review of the pivotal phase III ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s Keytruda in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to Keytruda monotherapy.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
