Dr. Chao on the Study of PD-L1 Inhibitors with NSCLC

Yvonne Chao, MD, PhD, member, Cancer Biology Program, UPMC Hillman Cancer Center, assistant professor, Division of Hematology/Oncology, University of Pittsburgh School of Medicine, discusses the study of various PD-L1 inhibitors in patients with non–small cell lung cancer (NSCLC).

Findings from the phase 3 Study 16113/EMPOWER-Lung 3 trial (NCT03409614) led to the FDA approval of the anti–PD-1 inhibitor cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for the treatment of adult patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations in November 2022. The phase 3 trial enrolled 466 patients with locally advanced NSCLC who were not eligible for surgical resection, who were not eligible for definitive chemoradiation, and patients with metastatic disease who had not received prior systemic treatment. The addition of cemiplimab led to a statistically significant improvement in overall survival (OS) vs chemotherapy alone.

Previously, in February 2021, the FDA approved cemiplimab monotherapy as a frontline treatment for patients with advanced NSCLC with a PD-L1 expression level of 50% or higher. That approval was based on data from the phase 3 EMPOWER-Lung 1 trial (NCT033088540), which also demonstrated an improvement in OS vs chemotherapy.

Another key trial evaluating PD-L1 inhibitors in NSCLC was the phase 3 CheckMate 227 trial (NCT02477826), which evaluated nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs platinum doublet chemotherapy alone in patients with treatment-naïve NSCLC. Data from the study demonstrated improved OS compared with chemotherapy alone, Chao notes.

The phase 3 CheckMate 9LA (NCT03215706) trial expanded on CheckMate 22y by evaluating 2 cycles of chemotherapy in combination with nivolumab plus ipilimumab compared with chemotherapy alon in previously untreated patients with NSCLC, Chao says. This study also showed that the immunotherapy-based combination also led to improvements in OS and progression-free survival, Chao concludes.