The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials. Patients received either Keytruda 200mg intravenously (IV) every 3 weeks (n=64) or 10mg/kg IV every 2 weeks (n=19) until disease progression, unacceptable toxicity, or a maximum of 24 months. The primary efficacy outcomes were objective response rate (ORR) and duration of response (DoR).
Results showed an ORR of 19% (95% CI, 11-29) in Keytruda-treated patients (complete response rate: 2%; partial response rate: 17%). Among the 16 responding patients, 94% had a DoR of ≥6 months, 63% had a DoR of ≥12 months, and 56% had a DoR of ≥18 months. Responses ranged from 4.1 to 35.8+ months. Adverse reactions occurring in SCLC patients were found to be similar to those occurring in patients with other solid tumors who received Keytruda as a single agent.
“Small cell lung cancer, which accounts for 10 to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” said Dr Patrick Ott, MD, PhD, clinical director, Center for Immuno-Oncology, Dana-Farber Cancer Institute. “The approval of Keytruda in small cell lung cancer provides an additional treatment option for patients based on the clinical response rates from KEYNOTE-158 and KEYNOTE-028.”
Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, is also approved for the treatment of non-small cell lung cancer, melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, merkel cell carcinoma, and renal cell carcinoma.
For more information visit keytruda.com.