Tony Mok, MD
Single-agent treatment with the PD-1 inhibitor pembrolizumab (Keytruda) improved overall survival (OS) versus chemotherapy as a frontline treatment for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) and a PD-L1 expression level ≥1%.
The approval was based on part 2 of cohort G in the KEYNOTE-021 trial, which showed that the frontline combination of pembrolizumab, pemetrexed, and carboplatin reduced the risk of progression or death compared with chemotherapy alone for patients with advanced nonsquamous NSCLC. Updated results for the study were presented at the 2017 ESMO Congress.2
At median follow-up of 18.7 months, the overall response rate was 56.7% for the pemetrexed arm compared with 31.7% with pemetrexed and carboplatin alone (95% CI, 7.2-40.9; P
= .0029). The risk of progression or death was reduced by 46% with pembrolizumab (HR, 0.54; 95% CI, 0.33-0.88; P
= .0067). There was also a trend toward an OS improvement with pembrolizumab (HR, 0.59; 95% CI, 0.34-1.05; P
Beyond the frontline, pembrolizumab is also approved in NSCLC as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) with disease progression on or after platinum-containing chemotherapy. Patients with EGFR
genomic tumor aberrations should have disease progression on FDA-approved targeted therapies for these aberrations, according to the FDA label.
- Brahmer JR, Rodríguez-Abreu D, Robinson AG, et al. Updated analysis of KEYNOTE-024: pembrolizumab vs platinum-based chemotherapy for advanced NSCLC with PD-L1 TPS ≥50%. Presented at: the IASLC 18th World Conference on Lung Cancer; October 15-18; Yokohama, Japan. Abstract OA 17.06 (ID 9582).
- Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Carboplatin (pem/carbo) Demonstrated Continued Benefit in Overall Response Rates and Progression-Free Survival Compared to Pem/Carbo Alone in Patients with First-Line Nonsquamous NSCLC. https://bit.ly/2ExmUXK . Published online September 8, 2017. Accessed April 9, 2018.