Phase III ECHO-301/KEYNOTE-252 study of epacadostat + Keytruda for metastatic melanoma did not meet endpoints. Incyte + Merck Inc.
Incyte Corporation and Merck have announced that an external Data Monitoring Committee (eDMC) 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.
The study�s second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with Keytruda. Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.
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