FDA Approves Nivolumab for Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved Bristol-Meyers Squibb Company’s nivolumab (Opdivo) for the treatment of metastatic small cell lung cancer (SCLC) that has progressed after platinum-based chemotherapy and at least 1 other line of therapy.

Approval for this indication was granted under accelerated approval based on the overall response rate (ORR) and duration of response (DOR). According to the FDA, continued approval for this indication will rely on data pertaining to clinical benefit yielded in confirmatory trials.

“Small cell lung cancer can be a very challenging disease, particularly for those who have already been through multiple types of treatment, as most patients relapse within a year of diagnosis,” said Andrea Ferris, president and chairman of LUNGevity Foundation, in a recent statement. “This approval marks a major milestone for the patients touched by this unrelenting disease and may motivate them to pursue further treatment where there previously were no other approved options.”

Nivolumab is a type of monoclonal antibody and a type of immune checkpoint inhibitor that may block PD-1 and help the immune system kill cancer cells.

The approval of the drug was based on data yielded from the SCLC cohort of the ongoing multicenter, multicohort, open-label phase 1/2 CheckMate -032 trial evaluating nivolumab monotherapy in patients with SCLC who experienced disease progression after platinum-based chemotherapy.

Of 109 patients administered nivolumab after platinum-based chemotherapy and at least 1 other prior line of therapy, 12% (n=13/109; 95% CI: 6.5-19.5) responded to treatment based on assessment by a Blinded Independent Central Review (BICR), regardless of PD-L1 expression. Additionally, 12 patients experienced a partial response (11%), and 1 patient experienced a complete response (0.9%).

In 10% of patients, nivolumab was discontinued, while in 25% of patients 1 dose was withheld due to an adverse reaction. In 45% of patients, serious adverse reactions occurred. Nivolumab’s approved dosing in this indication is 240 milligrams administered every 2 weeks via intravenous infusion until disease progression or unacceptable toxicity.

Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions, infusion reactions, and embryo-fetal toxicity are warnings associated with nivolumab treatment.

“While Immuno-Oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” said Leora Horn, MD, MSc, associate professor of medicine, Ingram associate professor of cancer research, director of the thoracic oncology program and assistant vice chairman for faculty development, Vanderbilt University Medical Center, in a recent statement. “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.”

Accounting for about 10% to 15% of all lung cancers, SCLC is 1of 2 main types of lung cancer. Approximately 27,000 cases of SCLC are expected to be diagnosed in 2018 within the United States. While SCLC is characterized as an aggressive disease, symptoms often are not detected until the cancer is at an advanced stage. Five-year survival rates for extensive stage SCLC, or stage IV, from the time of diagnosis, are about 2%.