Bristol-Myers Squibb reported positive Phase III results evaluating Opdivo (nivolumab) versus everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (RCC). The study was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint demonstrating improved overall survival in patients receiving Opdivo compared to the control arm.

Opdivo is Bristol-Myers Squibb’s key immuno-oncology drug. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the US Food and Drug Administration (FDA) as a monotherapy in two cancer indications. In March 2015, Opdivo received FDA approval treating patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

In the US, Opdivo is also indicated for treating unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval in July 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials, as monotherapy or in combination with other therapies, in which more than 8,000 patients have been enrolled worldwide.

Opdivo is a potential blockbuster drug for Bristol-Myers Squibb. A recent Thomson Reuters analysis estimated 2019 sales of $5.68 billion.

Source: Bristol-Myers Squibb