The U. S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with a diagnosis of metastatic squamous non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Last December 2014 the FDA approved Opdivo for unresectable or metastatic melanoma.
Opdivo is a programmed death receptor-1 (PD-1) blocking antibody that inhibits receptor-ligand interactions, blocking PD-1 pathway-mediated inhibition of anti-tumoral immune responses.
The approval was the result of a superior overall survival (OS) rate obtained from a recent open-label, multinational, multi-center randomized clinical trial in patients with NSCLS who experienced disease progression during or after one prior platinum-based chemotherapy regimen. Patients were allocated to either receive nivolumab (n=135) with a dose of 3 mg/kg as an intravenous infusion every 2 weeks or docetaxel (n=137) with a dose of 75 mg/m2 as an intravenous infusion every 3 weeks. Protocol pre-specified interim analysis results showed that Nivolumab (median of 9,2 months) significantly improved OS compared to docetaxel (median of 6 months).
In terms of adverse effects, which occurred in 117 patients under nivolumab the most common were dyspnea, fatigue, decreased appetite, cough and musculoskeletal pain. The most common grade 3 and 4 adverse events seen in at least 5% of patients that received nivolumab were dyspnea, musculoskeletal pain and fatigue. Moreover, immune-mediated adverse events included colitis, pneumonitis, nephritis/renal dysfunction, hypothyroidism, hepatitis, and hyperthyroidism.
“With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,” said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb in a recent news release. “As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.”