Patients (pts) with unresectable locally advanced non-small cell lung cancer (laNSCLC) who are not candidates for concurrent chemoradiation have often been excluded from immunotherapy trials, and their care represent an unmet medical need. We report post hoc analyses of pts with laNSCLC who received cemiplimab (anti–programmed cell death-1) from two Phase 3 clinical trials with long-term data.
EMPOWER-Lung 1 (NCT03088540) and EMPOWER-Lung 3 (NCT03409614) included 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. In EMPOWER-Lung 1 pts were randomised 1:1 to first-line (1L) cemiplimab monotherapy or chemo for NSCLC with ≥50% programmed cell death-ligand 1 (PD-L1) expression. In EMPOWER-Lung 3 pts were randomised 2:1 to 1L cemiplimab + chemo or placebo + chemo regardless of PD-L1 expression level.
In each trial, 15% of pts were treated for laNSCLC.
In EMPOWER-Lung 1, at ~3-year follow-up of pts with laNSCLC, 1L cemiplimab monotherapy led to a median overall survival (OS) of 26.1 vs 13.9 mo with chemo (HR: 0.67; 0.38–1.17; p=0.1532). Progression-free survival (PFS) was 8.1 vs 6.2 mo (HR: 0.56; 0.34–0.95; p=0.0286). Objective response rate (ORR) was 49% vs 31%. Median duration of response (DOR) was 18.8 vs 6.2 mo.
In EMPOWER-Lung 3, at ~2-year follow-up of pts with laNSCLC, greater efficacy was observed with 1L cemiplimab + chemo vs placebo + chemo. Median OS was 24.1 vs 13.8 mo (HR: 0.50; 0.27–0.95; p=0.0293) and median PFS was 12.5 vs 6.2 mo (HR: 0.34; 0.19–0.61; p=0.0002). ORR was 58% vs 29%. Median DOR was 27.8 vs 4.2 mo.
| EMPOWER-Lung 1† | EMPOWER-Lung 3 Part 2 | |
| Subgroup with laNSCLC | Cemiplimab (n=45) | Cemiplimab + chemo (n=45) |
| Study follow-up duration,‡ median (range), mo | 36.2 (24.4–53.7) vs 35.6 (24.3–53.6) | 28.7 (21.0–35.9) vs 29.3 (22.6–35.4) |
| OS median, mo | 26.1 vs 13.9 | 24.1 vs 13.8 |
| OS HR (95% CI) | 0.67 (0.38–1.17); p=0.1532 | 0.50 (0.27–0.95); p=0.0293 |
| PFS median, mo | 8.1 vs 6.2 | 12.5 vs 6.2 |
| PFS HR (95% CI) | 0.56 (0.34–0.95); p=0.0286 | 0.34 (0.19–0.61); p=0.0002 |
| ORR, % | 49 vs 31 | 58 vs 29 |
| Kaplan-Meier estimated DOR, median (95% CI), mo | 18.8 (6.4–NE) vs 6.2 (3.4–8.5) | 27.8 (13.1–27.8) vs 4.2 (3.0–10.3) |
| †PD-L1 ≥50% population. ‡From randomization to data cutoff. | ||
Long-term follow-up data from EMPOWER-Lung studies continue to suggest clinical benefit of 1L cemiplimab as monotherapy or in combination with platinum-based chemo in pts with unresectable laNSCLC who are not candidates for definitive concurrent chemoradiation.
NCT03088540 and NCT03409614
Medical writing support was provided by Rachel McGrandle MSc, of Prime, Knutsford, UK, funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Responsibility for all opinions, conclusions and data interpretation lies with the authors.