European Commission Approves Nivolumab for Previously Treated, Locally Advanced, Unresectable or Metastatic Urothelial Cancer

On June 2, the European Commission (EC) approved nivolumab (Opdivo) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. This makes nivolumab the first immuno-oncology agent approved in the European Union for the treatment of patients with this common type of bladder cancer.

“Bladder cancer has an estimated 151,000 new cases diagnosed annually in Europe, yet there have been few advancements in treatment for advanced bladder cancer during the last few decades,” said Margitta Retz, MD, Director of the Division Uro-Oncology of the Department of Urology, Technical University Munich, Germany. “The European Commission’s approval of nivolumab marks a significant advancement, with a notable objective response rate, and provides an important option to help patients with previously treated locally advanced unresectable or metastatic urothelial cancer.”

CheckMate 275

The approval was based on results from CheckMate 275, a phase II, open-label, single-arm, multicenter study evaluating nivoluamb in patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following treatment with a platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In this study, 270 patients received nivolumab 3 mg/kg administered intravenously every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint of the trial was objective response rate. Secondary endpoints included progression free survival and overall survival. In the trial, 20.0% (95% confidence interval [CI] = 15.4–25.3; 54 of 270) of patients responded to treatment with nivolumab. The percentage of patients with a complete response was 3.0% (8 of 270) and the percentage of patients with a partial response was 17% (46 of 270).

Half of the overall patient population (46%) in CheckMate 275 had a tumor programmed death-ligand 1 (PD-L1) expression of ≥ 1%, and efficacy was observed across tumor PD-L1 expressors and nonexpressors. The response rate was 25% in patients with tumor PD-L1 expression ≥ 1% (95% CI = 17.7–33.6) and 15.8% (95% CI = 10.3–22.7) in those with tumor PD-L1 expression < 1%. In all treated patients, the median progression-free survival was 2.0 months, the 12-month overall survival rate was 41% (95% CI = 34.8–47.1) and the median overall survival was 8.6 months (95% CI = 6.1–11.3).

Among the 270 patients who received nivolumab in CheckMate 275, 17.8% experienced a grade 3 or 4 treatment-related adverse event. The most frequently reported treatment-related adverse events of any grade included fatigue (16.7%), pruritis (9.3%), diarrhea (8.9%), decreased appetite (8.1%), hypothyroidism (7.8%), nausea (7.0%), asthenia (5.9%), rash (5.9%), and pyrexia (5.6%). The most frequent treatment-related grade 3–4 adverse events were fatigue (1.9%), diarrhea (1.9%), asthenia (1.5%), and rash (1.1%). Overall, 4.8% of patients discontinued therapy due to treatment-related adverse events of any grade, and 3.0% discontinued therapy due to grade 3–4 treatment-related adverse events. Treatment-related death occurred in four patients due to pneumonitis or cardiovascular failure.

“We are pleased with the European Commission’s approval of nivolumab for patients with previously treated locally advanced unresectable or metastatic urothelial carcinoma, many of whom have been in need of an additional treatment option,” said Murdo Gordon, Executive Vice President and Chief Commercial Officer, Bristol-Myers Squibb

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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