BMS reports response data from Phase I/IIa trial of IDO1 inhibitor/Opdivo combo

Bristol-Myers Squibb Co. (NYSE:BMY) reported data from the dose-expansion portion of the Phase I/IIa CA017-003 trial showing that oral BMS-986205 plus IV Opdivo nivolumab led to an objective response rate (ORR) of 32% and a disease control rate (DCR) of 44% in 25 evaluable heavily pretreated bladder cancer patients and an ORR of 14% and a DCR of 64% in 22 evaluable heavily pretreated cervical cancer patients. The evaluable patients received once-daily 100 or 200 mg BMS-986205 plus 240 mg Opdivo every 2 weeks or 480 mg Opdivo every 4 weeks. Data were presented at the Society for Immunotherapy of Cancer meeting in National Harbor, Md.

The open-label, international trial is slated to enroll over 900 patients with various advanced cancers to receive BMS-986205 plus Opdivo or BMS-986205 plus Opdivo and Yervoy ipilimumab. The maximum tolerated dose (MTD) of BMS-986205 was 200 mg in combination with Opdivo and the recommended dose for further study is 100 mg...