Incyte Eyes Big Phase III IDO Expansion, NewLink Plans First Pivotal Trial
NewLink is hoping FDA will accept its plans to run one Phase III registrational study of its IDO pathway inhibitor indoximod with an anti-PD-1 agent in frontline melanoma; Incyte updates its Phase III plans for epacadostat.
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There is now a move back to the principle of doing randomized Phase II studies before jumping into Phase III, says CEO Chuck Link, as Roche's Genentech exits broad IDO/TDO deal.
Following termination of pivotal trials in three tumor types testing its in-house IDO inhibitor BMS-986205, Bristol says it is "working quickly" to assess the development of Opdivo with Incyte's epacadostat.
Genentech's statements about IDO as an immuno-oncology target raise questions about the future of the drug class, but IDO leader Incyte has emerged unscathed for now.