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Nivolumab (Opdivo) Found Effective in Kidney Cancer
An open-label, randomized, phase III trial evaluating nivolumab (Opdivo, Bristol-Myers Squibb) versus everolimus (Afinitor, Novartis) in previously treated patients with advanced or metastatic renal cell carcinoma (RCC) was stopped early because an assessment conducted by an independent data-monitoring committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving nivolumab compared with the control arm.
In the CheckMate-025 trial, 821 patients were randomly assigned to receive either intravenous nivolumab (3 mg/kg every 2 weeks) or oral everolimus (10 mg daily) until documented disease progression or unacceptable toxicity occurred.
Nivolumab is a human monoclonal antibody that blocks the interaction between the programmed death-1 (PD-1) receptor and its ligands, PD-L1 and PD-L2. The binding of PD-L1 and PD-L2 to the PD-1 receptor on T cells inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to the inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, thereby releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Nivolumab is FDA-approved as monotherapy for two cancer indications. In March 2015, the drug was approved for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Nivolumab is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression after treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) and, if BRAF V600 mutation-positive, a BRAF inhibitor.
Nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 when Ono Pharmaceutical Co. announced that it had received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. Bristol-Myers Squibb is conducting a global development program to study nivolumab in multiple tumor types –– as monotherapy or in combination with other therapies –– in more than 8,000 patients.
RCC is the most common type of kidney cancer in adults, accounting for more than 100,000 deaths worldwide each year. Clear-cell RCC is the most prevalent type of RCC and constitutes 80% to 90% of all cases. RCC is approximately twice as common in men as in women, with the highest rates of the disease in North America and Europe. Globally, the 5-year survival rate for individuals diagnosed with advanced (metastatic) kidney cancer is 12%.
Sources: Bristol-Myers Squibb; July 20, 2015; and Opdivo Prescribing Information; March 2015.