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Bistol-Myers: Encouraging Response Observed With Opdivo Plus IDO1 Inhibitor

Bristol-Myers Squibb Co. (BMY) on Friday announced updated results for Opdivo (nivolumab) plus BMS-986205, a selective, once-daily oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor from the ongoing Phase 1/2a dose escalation and expansion study, CA017-003.

CA017-003 is an ongoing Phase 1/2a dose escalation and expansion study evaluating BMS-986205 in patients with advanced cancers in combination with other agents, including Opdivo and Yervoy (ipilimumab), at different doses and schedules.

The primary objectives of the dose escalation study are to establish the safety, tolerability, dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), maximum administered dose (MAD) or alternate dose; BMS-986205 doses from 25 to 400 mg once-daily (QD) were evaluated in combination with Opdivo given 240 mg every two weeks.

According to the company, it observed encouraging response with Opdivo Plus Investigational IDO1 Inhibitor, BMS-986205, in heavily pre-treated patients with advanced cancers in CA017-003.

In addition, increased proliferating cytotoxic T cell count and decreased kynurenine production were observed, providing evidence of immunomodulation within the tumor. Further, the safety profile is consistent with that previously reported for the BMS-986205 plus Opdivo combination.

IDO1 is an enzyme that breaks down tryptophan, an essential amino acid which fuels cytotoxic T cells, to help regulate the immune system and avoid an over-response to threats.

In the dose escalation phase of the study, the maximum tolerated dose (primary endpoint) of BMS-986205 in combination with Opdivo was 200 mg. Based on safety and pharmacodynamic data, the recommended dose for further study was determined to be 100 mg.

In the dose expansion phase, findings for anti-tumor activity (primary endpoint) were reported in two cohorts - heavily pre-treated bladder and cervical cancer patients. In the bladder cancer cohort, the objective response rate or ORR and disease control rate or DCR were 32% and 44%, respectively. In the cervical cancer cohort, the ORR was 14% and DCR was 64%.

The study also measured ORR by PD-L1 expression levels. In patients who express PD-L1 =1%, ORR was 46% and 25% in the bladder and cervical cancer cohorts, respectively.
In patients who express PD-L1 <1%, ORR was 22% in the bladder cancer cohort, while no response was observed in cervical cancer patients. Response was observed regardless of prior lines of therapy.

Bristol-Myers said these data will be presented Saturday, November 11 at the Society for Immunotherapy of Cancer or SITC 32nd Annual Meeting in National Harbor, Maryland.

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