FDA granted an accelerated approval to nivolumab (Opdivo) for patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy.
The drug is sponsored by Bristol-Myers Squibb Co. Inc.
Approval was based on demonstration of a durable overall response rate in a subgroup of patients from CheckMate-032 (NCT01928394), a multicenter, open-label trial in patients with metastatic solid tumors. This subgroup comprised 109 patients with metastatic SCLC, with disease progression after platinum-based therapy and at least one other prior line of therapy, regardless of tumor PD-L1 status. All patients received nivolumab 3 mg/kg by intravenous infusion over 60 minutes every 2 weeks.
The major efficacy outcome measures were overall response rate and duration of response according to RECIST v1.1 as assessed by blinded independent central review. The ORR was 12% (95% CI: 6.5, 19.5). Responses were durable for 6 months or longer in 77%, 12 months or longer in 62%, and 18 months or longer in 39% of the 13 responding patients. PD-L1 tumor status did not appear to be predictive of response.
Safety data was evaluated in 245 patients with metastatic SCLC with disease progression following platinum-based chemotherapy and received at least one dose of nivolumab.
