BMS pulls the plug on Phase 3 trials of IDO1 inhibitor

Bristol-Myers Squibb has terminated two pivotal Phase 3 trials of BMS-986205, an IDO1 inhibitor acquired through its $800 million acquisition of Flexus in 2015, investigating its efficacy in non-small cell lung cancer and head and neck cancer in combination with the company’s flagship immunotherapy Opdivo (nivolumab).

Both trials were moving through the early phases of recruitment when Incyte revealed the Phase 3 failure of its own IDO1 inhibitor in combination with MSD’s Keytruda (pembrolizumab). BMS cited that its "business objectives have changed" as a reason for the decision, though critics have concluded that Incyte’s major setback in the space was a significant factor.

Additionally, BMS has cut short its recruitment of a trial of the combo in metastatic or unresectable melanoma – the same indication Incyte failed in. While the trial is active, it has only gathered 72 participants, not even close to its planned capacity of 700.  

"[Bristol-Myers] remains committed to continued research of BMS-986205-based combinations in an informed and scientifically robust manner," a spokesperson for BMS commented. "Insights from the evolving treatment landscape have brought to light the importance of better understanding the biological effects of the molecule, and identifying relevant biomarkers capable of selecting patient populations most likely to benefit from treatment. Therefore, it remains a priority to study BMS-986205-based combinations in the same and additional tumour types in early phase studies."

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