This is the first approval in the small cell lung cancer space in nearly two decades.
The Food and Drug Administration (FDA) approved Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) whose disease progressed on two or more previous lines of therapy, according to Bristol-Myers Squibb, the manufacturer of the immunotherapy agent.
This approval has garnered excitement in the lung cancer space, especially because it is for small cell lung cancer — a rare subtype of the disease that accounts for 10 to 15 percent of all lung cancers, according to the American Cancer Society. This is the first approval in the space in nearly two decades.
“Small cell lung cancer research has been an unmet need for decades,” said Bonnie J. Addario, founder and chair of the Bonnie J. Addario Lung Cancer Foundation.
“The approval of Opdivo for small cell lung cancer is just one more example of the FDA working on behalf of patients day and night,” she added. “This will bring hope to many patients who have been waiting for too long.”
Opdivo blocks the PD-1 protein, which prevents T cells — which are a part of the immune system – from attacking other cells in an individual’s body. By inhibiting the function of the PD-1 protein, drugs like Opdivo can help the body recognize and then attack the cancer.
The agency based its approval on findings from the phase 1/2 CheckMate-032 trial, designed to compare Opdivo monotherapy with the combination use of Opdivo plus Yervoy (ipilimumab) in patients with advanced or metastatic tumors, including SCLC, who were previously treated with a platinum-based chemotherapy.
There were 109 patients with SCLC in the study, and 12 percent of them (13 patients) responded to the treatment, regardless of their PD-L1 expression. Eleven percent (12 patients) had a partial response, and one person had a complete response. Median duration of response was 17.9 months, ranging between three months and 42.1 months.
It should be noted that 10 percent of patients discontinued treatment with Opdivo, and one dose withheld in 25 percent due to the drug’s side effects, with serious side effects occurring in 45 percent of patients.
The most frequent serious adverse reactions reported in at least 2 percent of patients were pneumonia, dyspnea (difficulty breathing), pneumonitis, pleural effusion and dehydration. The most common adverse reactions (reported in 20 percent of patients or more) were fatigue (45 percent), decreased appetite (27 percent), musculoskeletal pain (25 percent), dyspnea (22 percent), nausea (22 percent), diarrhea (21 percent), constipation (20 percent) and cough (20 percent).
“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, M.D., M.Sc., 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 press release. “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.”