Bristol: 1st Results for Opdivo + Yervoy in Liver Cancer at ASCO

Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months

Data demonstrate potential of Immuno-Oncology combination in fourth most common cause of cancer death worldwide

Bristol-Myers Squibb Company (BMY) today announced first results from the Opdivo (nivolumab) plus Yervoy (ipilimumab) cohort of the Phase 1/2 CheckMate -040 study, evaluating the Immuno-Oncology combination in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. With a minimum follow-up of 28 months, the blinded independent central review (BICR) objective response rate (ORR) was 31% per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). At the time of data cutoff, the median duration of response (DoR) was 17.5 months (95% CI: 11.1, N/A). These data (Abstract #4012) will be featured at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019 in Chicago in a poster display on Monday, June 3 from 8-11 AM CDT, and in a poster discussion from 3-4:30 PM CDT.

The study randomized patients into three arms evaluating three different dosing schedules of the Opdivo plus Yervoy combination: Opdivo 1 mg/kg and Yervoy 3 mg/kg every three weeks (Q3W) for four cycles, followed by Opdivo 240 mg every two weeks (Q2W) (Arm A); Opdivo 3 mg/kg and Yervoy 1 mg/kg Q3W for four cycles, followed by Opdivo 240 mg Q2W (Arm B); or Opdivo 3 mg/kg Q2W and Yervoy 1 mg/kg every six weeks (Q6W) (Arm C).

Meaningful responses were observed across treatment arms. Patients in Arm A experienced the longest median overall survival (OS) of the cohort at 22.8 months (95% CI: 9.4, N/A) and a 30-month OS rate of 44% (95% CI: 29.5, 57). Opdivo and Yervoy demonstrated a disease control rate (DCR) of 54%, 43% and 49% per BICR using RECIST v1.1 across treatment arms A, B and C, respectively. Across the cohort, 5% of patients experienced a complete response and 26% experienced a partial response. Patient responses were achieved regardless of baseline tumor PD-L1 status. Opdivo plus Yervoy showed an acceptable safety profile and the addition of Yervoy yielded no new safety signals in any treatment arm.

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