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Keytruda combo fails at Phase 3 in metastatic melanoma

Published on 09/04/18 at 09:37am

Shares in biopharma firm Incyte were sent reeling by as much as 20% when the company announced that the results of a Phase 3 study had revealed that its IDO1 inhibitor epacadostat, when applied in combination with MSD’s Keytruda (pembrolizumab), failed to meet its primary endpoint of improving progression-free survival (PFS) in patients with unresectable or metastatic melanoma compared to Keytruda alone.

The trial stratified each of the 700 participants by tumour PD-L1 expression and BRAF mutation status. While it failed to meet its primary goal, it was also noted that the study’s second primary endpoint of overall survival “is not expected to reach statistical significance”.

In a statement, both companies said they would now “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.”

“While we are disappointed that this study did not confirm the efficacy of epacadostat in combination with KEYTRUDA in 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,” commented Dr Steven Stein, Chief Medical Officer at Incyte. “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.”

Matt Fellows

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