KEY TAKEAWAYS
- The EMPOWER-Lung 3 phase III study evaluated the effects of cemiplimab (an anti-PD-1) combined with chemotherapy on patients with advanced NSCLC.
- The trial’s primary endpoint was OS, and secondary endpoints included PFS and ORR.
- The study demonstrated that combining cemiplimab with chemotherapy significantly prolonged the median OS of patients with advanced NSCLC compared to chemotherapy alone.
The EMPOWER-Lung 3 phase III trial randomized participants in a 2:1 ratio to undergo 4 sessions of platinum-based doublet chemotherapy. This was paired with either 350 mg of cemiplimab (312 participants) or a placebo (154 participants), administered every three weeks, spanning up to 108 weeks. The primary goal was to measure OS, while secondary objectives were to ascertain progression-free survival (PFS) and objective response rates (ORR) in non-small cell lung cancer (NSCLC).
After a median follow-up of 28.4 months, the cemiplimab + chemotherapy consistently outperformed standalone chemotherapy in terms of OS and PFS. Specifically, the median OS was 21.1 months with the combined treatment against 12.9 months with only chemotherapy (HR = 0.65, 0.51-0.82, p = 0.0003). Median PFS stood at 8.2 months for the combination versus 5.5 months for solo chemotherapy (HR = 0.55, 0.44-0.68, p < 0.0001). The ORRs were 43.6% and 22.1%, with response durations being 16.4 and 7.3 months, respectively. The safety dynamics for extended usage of the cemiplimab and chemotherapy combo aligned with previously shared data, with grade ≥3 treatment-induced side effects seen in 48.7% of the combo group and 32.7% of the solo chemotherapy group.
At a follow-up of 28.4 months, the EMPOWER-Lung 3 study consistently revealed that cemiplimab, when combined with chemotherapy, offers better outcomes than chemotherapy alone for patients with advanced types of NSCLC. This holds true irrespective of PD-L1 expression levels, excluding EGFR, ALK, or ROS1 deviations.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03409614
Makharadze, T., Gogishvili, M., Melkadze, T., Baramidze, A., Giorgadze, D., Penkov, K.D., Laktionov, K., Nemsadze, G., Nechaeva, M., Rozhkova, I., Kalinka, E., Li, S., Li, Y., Kaul, M., Pouliot, J., Seebach, F., Lowy, I., Gullo, G., Rietschel, P. 5O – Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: Longer follow-up results from the phase III EMPOWER-Lung 3 trial. Journal of Thoracic Oncology (2023) 18 (4S): S35-S88.
