Bristol-Myers announced that its Opdivo (nivolumab) has received approval from the U.S. Food and Drug Administration as the first and only Immuno-Oncology treatment option 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.
According to the American Cancer Society, and as written in Bristol-Myers’ press release, small cell lung cancer is one of two main types of lung cancer and accounts for about 10% to 15% of all lung cancers.
The National Cancer Institute has said it is an aggressive disease, and symptoms often are not detected until the cancer is at an advanced stage.
According to Decision Resources Group Epidemiology Data, in the United States, about 27,000 cases of SCLC are expected to be diagnosed in 2018. The American Cancer Society has noted that from the time of diagnosis, five-year survival rates for extensive stage SCLC, or Stage IV, are about 2%.
“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.
“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.”
“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., the 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.
“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.”
Bristol Myers wrote in its press release on its website, “The approval was based on data from the SCLC cohort of the ongoing Phase 1/2 CheckMate -032 study evaluating Opdivo in patients who experienced disease progression after platinum-based chemotherapy. Of 109 patients receiving Opdivo after platinum-based chemotherapy and at least one 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. Twelve patients had a partial response (11%), and one patient had a complete response (0.9%). Among these responders, the median DOR was 17.9 months (95% CI: 7.9-42.1; range: 3.0-42.1 months) Opdivo was discontinued in 10% of patients, and one dose was withheld in 25% of patients for an adverse reaction.1 Serious adverse reactions occurred in 45% of patients. The approved dosing for Opdivo in this indication is 240 milligrams administered every 2 weeks by intravenous infusion until disease progression or unacceptable toxicity.”