Bristol-Myers Squibb confirmed that it halted pivotal studies of the experimental IDO inhibitor BMS-986205 in three tumour types in the wake of a recent late-stage trial failure for Incyte's investigational IDO1 inhibitor epacadostat. Bristol-Myers Squibb said "we believe it is important to follow the science to make decisions that will result in clinically meaningful outcomes for patients."
Merck & Co. and Incyte announced last month that a Phase III study investigating the combination of the anti-PD-1 drug Keytruda (pembrolizumab) with epacadostat in patients with unresectable or metastatic melanoma failed to meet its primary endpoint of progression-free survival (PFS). The companies noted that an external Data Monitoring Committee review of the study determined that the combination of Keytruda and epacadostat did not improve PFS in the overall population compared to Keytruda monotherapy. For related analysis, see ViewPoints: ECHO-301 failure will reverberate throughout I/O universe.
Following the trial failure, NewLink Genetics began an assessment of its clinical programmes for indoximod and NLG802, which both target the IDO pathway. The drugmaker later indicated that it will not initiate the randomised portion of the Phase III Indigo301 study of indoximod in combination with Keytruda or Bristol-Myers Squibb's PD-1 inhibitor Opdivo (nivolumab), but will instead review the design, trial size and feasibility of an alternative randomised evaluation of indoximod in melanoma.
Bristol-Myers Squibb, which gained BMS-986205 via a licensing deal with Flexus Biosciences that included an $800-million upfront payment, said "based on emerging data on the IDO pathway, we closed registrational studies" of BMS-986205 in melanoma, squamous cell carcinoma of the head and neck and non-small-cell lung cancer. However, the company noted that it is "committed to continued research" of BMS-986205-based combinations, and will continue the Phase I/II study CA017-003, which is evaluating the drug in combination with Opdivo, as well as with Opdivo and Yervoy (ipilimumab), in cancers that are advanced or have spread.
Meanwhile, Incyte announced Tuesday that enrolment will be halted in two pivotal trials of epacadostat in combination with Opdivo, as well as in four pivotal studies in combination with Keytruda. The company noted that it will not initiate a pivotal trial combining epacadostat with AstraZeneca's PD-1 inhibitor Imfinzi (durvalumab) in Stage 3 lung cancer. Incyte added that it will continue to study epacadostat in immunotherapy combination proof-of-concept trials, which will include "hypotheses distinct from combinations with PD-1 and PD-L1 antagonists."
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