AUGUST 21, 2018
FDA Approves Opdivo as Third-Line Rx for SCLC .
The FDA granted accelerated approval to Nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic small cell lung cancer (SCLC) whose disease progresses after platinum-based chemotherapy and at least one other line of therapy.
“While immuno-oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” noted Leora Horn, MD, MSc, the director of the Thoracic Oncology Program and assistant vice chairman for faculty development at Vanderbilt University Medical Center in Nashville, Tenn. “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.”
The approval was based on demonstration of a durable overall response rate (ORR) in a subgroup of patients from the ongoing CheckMate-032 multicenter, open-label trial in patients with metastatic solid tumors (ClinicalTrials.gov identifier: NCT01928394). This subgroup included 109 patients with metastatic SCLC with disease progression after platinum-based therapy and at least one other prior line of therapy. All of the patients received 3 mg/kg of IV nivolumab over 60 minutes every two weeks.
The major efficacy outcome measures were ORR and duration of response (DOR) according to RECIST v1.1, as assessed by blinded independent central review. Thirteen of the 109 patients (12%; 95% CI, 6.5%-19.5%) responded to treatment based on assessment by the blinded review. Twelve patients had a partial response (11%), and one patient had a complete response (0.9%). The median DOR was 17.9 months (95% CI, 7.9-42.1 months; range, 3.0-42.1 months); 77% of patients had responses lasting at least six months, 62% had responses lasting at least 12 months and 39% had responses lasting at least 18 months. Programmed cell death ligand-1, or PD-L1, tumor status did not appear to predict response. ...