Nivolumab (Opdivo) in combination with ipilimumab (Yervoy) is active and well tolerated among patients with previously treated metastatic urothelial carcinoma, according to preliminary findings presented 31st Annual Meeting and Associated Programs of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland.1
Results from the bladder cancer cohort of the open-label, phase 1/2 CheckMate-032 (ClinicalTrials.gov Identifier: NCT01928394) showed that 38.5% (95% CI, 20.2-59.4) of patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum-based therapy achieved an objective response with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg. In contrast, 26.0% (95% CI, 17.9-35.5) of patients treated with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg achieved a response.
Investigators enrolled 208 patients who had received 1 or more prior lines of platinum-based therapy. Patients received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 cycles, followed by nivolumab 3 mg/kg alone every 2 weeks until disease progression or unacceptable toxicity.
No new safety signals were observed, and the incidence of grade 3 to 4 treatment-related adverse events was similar between treatment arms. Nearly 8% of patients in the nivolumab 1 mg/kg arm discontinued therapy due to adverse events, vs 13.5% in the nivolumab 3 mg/kg group.
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Nivolumab plus ipilimumab is indicated for the treatment of patients with unresectable or metastatic melanoma. As a single agent, nivolumab is approved for advanced melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer, and classical Hodgkin lymphoma.
- Opdivo (nivolumab) and Yervoy (ipilimumab) regimen shows promising efficacy and safety in previously treated patients with advanced form of bladder cancer. Bristol-Myers Squibb website. http://news.bms.com/press-release/bmy/opdivo-nivolumab-and-yervoy-ipilimumab-regimen-shows-promising-efficacy-and-safety. Updated November 12, 2016. Accessed November 16, 2016.