The Food and Drug Administration (FDA) has approved Opdivo (nivolumab; Bristol-Myers Squibb) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and ≥1 other line of therapy.
Opdivo is a human programmed death receptor-1 (PD-1)-blocking antibody. It is already indicated to treat certain patients with non-small cell lung cancer (NSCLC), head and neck cancer, renal cancer, urothelial cancer, colorectal cancer, hepatocellular carcinoma, lymphoma, and melanoma.
The new approval is based on data from the ongoing Phase 1/2 multicenter, open-label CheckMate -032 study that included 109 patients who had disease progression after platinum-based chemotherapy and ≥1 other prior line of therapy. Study patients received Opdivo 3mg/kg given by intravenous infusion over 60 minutes every 2 weeks. The major efficacy outcome was confirmed overall response rate (ORR), further characterized by duration of response (DOR).
Efficacy data showed that 12% of patients (N=13/109; 95% CI, 6.5–19.5) responded to treatment based on assessment by a Blinded Independent Central Review, regardless of PD-L1 expression. Of the responders, 11% had a partial response, and 1 patient had a complete response (0.9%). The median DOR among responders was 17.9 months (95% CI, 7.9–42.1; range: 3.0–42.1 months).
Safety data showed the most common adverse reactions (≥20% of patients) were fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, and cough.
“Today’s approval of nivolumab is particularly exciting considering it is the first checkpoint inhibitor approved for these specific patients, and now we can finally treat this devastating disease from a different angle,” said Leora Horn, MD, MSc.
For more information visit Opdivo.com.