Dr Creelan on the Promise of Cemiplimab in Squamous NSCLC

Ben Creelan, MD, thoracic oncologist, Moffitt Cancer Center, discusses key findings from a pooled analysis of treatment with cemiplimab-rwlc (Libtayo) derived from the phase 3 EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614) trials in patients with squamous non–small cell lung cancer (NSCLC).

Both the EMPOWER-Lung 1 trial and part 2 of the EMPOWER-Lung 3 trial evaluated patients with squamous or nonsquamous advanced NSCLC who did not harbor EGFR, ALK or ROS1 aberrations. Patients in EMPOWER-Lung 1 were randomly assigned 1:1 to receive first-line cemiplimab vs platinum-doublet chemotherapy, whereas those in the EMPOWER-Lung 3 trial were randomly assigned 2:1 to cemiplimab or placebo plus chemotherapy regardless of PD-L1 expression. Across both trials, 43% of patients had squamous histology.

Long-term follow-up data from the EMPOWER-Lung 1 and EMPOWER-Lung 3 trials revealed significant clinical benefits associated with cemiplimab when used as a first-line monotherapy or in combination with platinum chemotherapy for patients with squamous NSCLC, Creelan reports. In EMPOWER-Lung 1, patients with squamous disease who were treated with cemiplimab monotherapy and achieved a median overall survival (OS) of 22.7 months vs 13.5 months with chemotherapy (HR,0.51; 95% CI, 0.37-0.69) at a median follow-up of 37.1 months. The median progression-free survival (PFS) was 8.3 months vs 5.9 months (HR, 0.44; 95% CI, 0.32-0.59).

Although Creelan suggests that the robust survival outcomes may raise questions regarding the possibility of sampling error, robust survival benefit surpassing 22 months was also observed in part 2 of the EMPOWER-Lung 3 trial. Patients with squamous histology experienced a median OS of 22.3 months with cemiplimab plus chemotherapy vs 13.8 months with placebo plus chemotherapy (HR, 0.61; 95% CI, 0.42-0.87), with a median follow-up of 28.4 months. The median PFS was 8.2 months vs 4.9 months (HR, 0.56; 95% CI, 0.41-0.78).

The observed survival benefits exceeded expectations, particularly as the study was conducted in regions with potentially more limited access to medical resources, Creelan notes. Additionally, the pooled analysis highlighted differences among PD-1 inhibitors, with cemiplimab demonstrating potentially superior efficacy compared with historical OS rates for pembrolizumab (Keytruda) in patients with squamous NSCLC, Creelan states.

These findings underscore the potential of cemiplimab as a promising therapeutic option for patients with squamous NSCLC and emphasize the evolving treatment landscape with PD-1 inhibitors, Creelan concludes.