KEY TAKEAWAYS
- The post hoc analyses were conducted on pts with laNSCLC who received cemiplimab (anti-programmed cell death-1) from two phase III clinical trials with long-term data.
- Patients were randomly assigned in a 1:1 ratio to 1L cemiplimab monotherapy or chemo for NSCLC with ≥50% PD-L1.
- EMPOWER-Lung trials show 1L cemiplimab benefits unresectable laNSCLC patients ineligible for chemoradiation, with promising long-term outcomes.
Patients (pts) with squamous or non-squamous NSCLC that was metastatic or locally advanced (not suitable for definitive concurrent chemoradiation) without EGFR, ALK, or ROS1 genomic aberrations were included in EMPOWER-Lung 1 and EMPOWER-Lung 3 studies. In EMPOWER-Lung 1, pts were randomly assigned to first-line cemiplimab monotherapy or chemo for NSCLC with ≥50% programmed cell death-ligand 1 (PD-L1) expression at a 1:1 ratio. In EMPOWER-Lung 3, pts were randomly assigned to first-line cemiplimab + chemo or placebo + chemo regardless of PD-L1 expression level at a 2:1 ratio.
In both studies, 15% of pts received treatment for laNSCLC. EMPOWER-Lung 1 indicates that 1L cemiplimab monotherapy resulted in a median overall survival (OS) of 26.1 vs 13.9 mo with chemo (HR: 0.67; 0.38–1.17; p = 0.1532) after a follow-up of 3 years. There was an improvement in PFS of 8.1 vs 6.2 months (HR: 0.56; 0.34–0.95; p = 0.0286), while the objective response rate (ORR) was 49% vs 31%. The median duration of response (DOR) was 18.8 vs 6.2 mo. In comparison, EMPOWER-Lung 3 trial indicates that the combination of 1L cemiplimab and chemotherapy was more effective than placebo plus chemotherapy in patients with laNSCLC after a follow-up of approximately two years. The Median OS was 24.1 vs 13.8 mo (HR: 0.50; 0.27–0.95; p = 0.0293), and median PFS was longer for the cemiplimab combination (12.5 vs 6.2 months; HR: 0.34; 0.19–0.61; p = 0.0002), and the ORR was higher (58% vs 29%). Median DOR was 27.8 vs 4.2 mo.
The EMPOWER-Lung studies have indicated that 1L cemiplimab, either as monotherapy or combined with platinum-based chemotherapy, is beneficial for patients with unresectable laNSCLC who are not eligible for definitive concurrent chemoradiation. The treatment approach has shown promising long-term follow-up data.
Source: https://www.jto.org/article/S1556-0864(23)00369-6/fulltext
Clinical Trials: https://classic.clinicaltrials.gov/ct2/show/NCT03088540
https://classic.clinicaltrials.gov/ct2/show/NCT03409614
Kalinka, E., Bondarenko, I., Gogishvili, M., Melkadze, T., Baramidze, A., Sezer, A., Makharadze, T., Kilickap, S., Gumus, M., Penkov, K.D., Giorgadze, D., Özgüroglu, M., He, X., Pouliot, J., Seebach, F., Lowy, I., Gullo, G., Rietschel, P. Journal of Thoracic Oncology (2023)
