Bristol-Myers Squibb announced that Opdivo (nivolumab) received approval from the FDA 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.1 Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1
“At Bristol-Myers Squibb, we recognize the critical need to provide patients with cancer therapies that may offer more durable responses, particularly for those living with hard-to-treat, aggressive diseases like small cell lung cancer,”2 said Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb. “This approval builds on our heritage of bringing Immuno-Oncology therapies to patients with other types of thoracic cancers. It also reinforces our commitment to bringing transformative treatments to patients in urgent need of effective new options.”
Opdivo is associated with the following Warnings and Precautions: immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.1 Please see the Important Safety Information section below.
This approval for Opdivo in patients with SCLC whose cancer has progressed after two or more prior lines of therapy was granted priority review from the FDA.
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.1 Of 109 patients receiving Opdivo after platinum-based chemotherapy and at least one other prior line of therapy, 12 percent (n=13/109; 95 percent CI: 6.5-19.5) responded to treatment based on assessment by a Blinded Independent Central Review (BICR), regardless of PD-L1 expression.1,3 Twelve patients had a partial response (11%), and one patient had a complete response (0.9 percent).1,3
Among these responders, the median DOR was 17.9 months (95 percent CI: 7.9-42.1; range: 3.0-42.1 months).3 Opdivo was discontinued in 10 percent of patients, and one dose was withheld in 25 percent of patients for an adverse reaction.1 Serious adverse reactions occurred in 45 percent of patients.1 The approved dosing for Opdivo in this indication is 240 milligrams administered every two weeks by intravenous infusion until disease progression or unacceptable toxicity.1
“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. “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.”1
Small cell lung cancer is one of two main types of lung cancer and accounts for about 10 percent to 15 percent of all lung cancers.4 Small cell lung cancer is an aggressive disease, and symptoms often are not detected until the cancer is at an advanced stage.2 In the United States, about 27,000 cases of SCLC are expected to be diagnosed in 2018.5 From the time of diagnosis, five-year survival rates for extensive stage SCLC, or Stage IV, are about 2 percent.6
“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,”7 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.”
1. Opdivo Prescribing Information. Opdivo U.S. Product Information. Last Updated: August 2018. Princeton, NJ: Bristol-Myers Squibb Company.
2. National Cancer Institute. Small Cell Lung Cancer Treatment. Lung Cancer. https://www.cancer.gov/types/lung/hp/small-cell-lung-treatment-pdq. Updated April 20, 2018. Accessed May 30, 2018.
3. Data on file. NIVO 403. Princeton, NJ: Bristol-Myers Squibb.
4. American Cancer Society. Key Statistics About Small Cell Lung Cancer. https://www.cancer.org/cancer/small-cell-lung-cancer/about/key-statistics.html. Revised January 4, 2018. Accessed May 30, 2018.
5. Decision Resources Group Epidemiology Data. Burlington, MA: Decision Resources Group.
6. American Cancer Society. Small Cell Lung Cancer Survival Rates, by Stage. https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 30, 2018.
(Source: Bristol-Myers Squibb Company)
Filed Under: Oncology