FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer

Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response.

This approval for nivolumab had been granted Priority Review from the FDA. It was based on data from the SCLC cohort of the ongoing phase I/II CheckMate-032 study evaluating nivolumab monotherapy in patients who experienced disease progression after platinum-based chemotherapy.

CheckMate-032 Details

Of 109 patients receiving nivolumab after platinum-based chemotherapy and at least one other prior line of therapy, 12% (n = 13/109; 95% confidence interval [CI] = 6.5%–19.5%) responded to treatment based on assessment by a blinded independent central review, regardless of programmed death-ligand 1 (PD-L1) expression. Twelve patients had a partial response (11%), and one patient had a complete response (0.9%). Among these responders, the median duration of response was 17.9 months (95% CI = 7.9­–42.1; range = 3.0–42.1 months).

Nivolumab was discontinued in 10% of patients, and 1 dose was withheld in 25% of patients for an adverse reaction. Serious adverse reactions occurred in 45% of patients. The approved dosing for nivolumab in this indication is 240 mg administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity.

The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. The most common adverse reactions (reported in at least 20% of patients) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%).

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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