Bristol-Myers reports data from CheckMate-016 kidney cancer study
Bristol-Myers Squibb announced updated results from the Phase 1 CheckMate -016 trial, which evaluated the safety and tolerability of Opdivo at different doses as part of a regimen with Yervoy, sunitinib or pazopanib in previously treated and treatment-naive patients with metastatic renal cell carcinoma. These updated results include findings for the Opdivo and Yervoy combinations with approximately two years of follow-up, which showed the overall response rate was 40.4% in both arms. Of the 38 responders in both treatment arms, 39.5% had an ongoing response, with a median duration of response of 20.4 months in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and 19.7 months in the Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm. The overall survival rate at 12 months was 81% and 85% for Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm and Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm, respectively, and at 24 months was 67% and 70%, respectively. There were fewer Grade 3/4 treatment-related adverse events reported in the Opdivo 3 mg/kg plus Yervoy 1 mg/kg arm -- 38.3% -- than with Opdivo 1 mg/kg plus Yervoy 3 mg/kg arm -- 61.7%. Discontinuations due to treatment-related AEs included five and 13 patients in the Opdivo 3 mg/kg and Yervoy 1 mg/kg and Opdivo 1 mg/kg and Yervoy 3 mg/kg arms, respectively. Based on these results, further development of the Opdivo 1 mg/kg and Yervoy 3 mg/kg regimen was not pursued.