Suresh S. Ramalingam, MD
Amid rapid-fire developments in non–small cell lung cancer (NSCLC) research, the role of checkpoint immunotherapy continues to mature. Experts from the United States, France, and Italy discussed the evolution of therapy for patients with advanced nonsquamous disease during a recent OncLive®
panel. Moderator Suresh S.
The approvals issued thus far differ in disease settings, patient populations, and use of PD-L1 expression levels to select candidates for treatment.
Pembrolizumab Establishes First-Line Niche
Pembrolizumab was originally approved by the FDA for the second-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 at any level, regardless of histology. Indications for pembrolizumab monotherapy were subsequently expanded to include treatment-naïve patients whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50%.1
This was based on the results of the randomized phase III KEYNOTE-024 trial in which pembrolizumab was compared with investigator’s choice of chemotherapy for advanced NSCLC tumors with PD-L1 expression with TPS ≥50%.2
Patients in the chemotherapy arm were permitted to cross over to pembrolizumab after disease progression. Approximately 30% of the more than 1600 patients screened had the enrollment biomarker and 305 were enrolled.2 The primary endpoint was median progression-free survival (PFS), which reached 10.3 months in the pembrolizumab arm versus 6 months in the chemotherapy arm (HR for disease progression or death, 0.50; 95% CI, 0.37-0.68; P <.001).2 Investigators presented updated findings at the 2017 American Society of Clinical Oncology Annual Meeting, which showed significantly better median PFS in the pembrolizumab arm than in the chemotherapy arm (HR, 0.50; P <.0001) and significantly better overall survival (OS; HR, 0.60; P
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