The EMPOWER-Lung 1 Trial: Five-Year Outcomes of Cemiplimab Monotherapy in Advanced NSCLC

Pharmacy Times® interviewed Ana Baramidze, MD, PhD, head of the department of clinical research at Todua Clinic in Tbilisi, Georgia, on her presentation at the 2024 World Conference on Lung Cancer (WCLC) on 5 year outcomes of the EMPOWER-Lung 1 trial (NCT03409614) investigating cemiplimab (Libtayo; Regeneron Pharmaceuticals) monotherapy in the first-line setting in patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression ≥50%.

Pharmacy Times: What was the rationale and study design of the phase 2 EMPOWER-Lung 1 trial presented at the 2024 World Conference on Lung Cancer?

Ana Baramidze, MD, PhD: The EMPOWER-Lung 1 trial is a phase 2 randomized study comparing cemiplimab monotherapy vs investigator’s choice of chemotherapy in patients with treatment-naive, advanced NSCLC with PD-L1 expression in 50% or more of tumor cells and no [EGFR gene mutations, ALK gene translocations, or ROS1 fusions]. And the primary end points of this study were overall survival [OS] and progression-free survival [PFS].

An innovative feature of this study was to allow patients to continue optional change of treatment. After disease progression, patients randomized to chemotherapy were allowed to cross over to optional cemiplimab monotherapy, and this crossover occurred in 75% of patients and those randomized to cemiplimab monotherapy were allowed optional continuation of the cemiplimab monotherapy with addition of histology-specific chemotherapy cycles.

Pharmacy Times: What were the key efficacy findings from the phase 2 EMPOWER-Lung 1 trial?

Baramidze: So today, earlier at WCLC, I presented 5-year follow-up results of EMPOWER-Lung 1. And it's interesting that both initial and follow up results showed and demonstrated that cemiplimab has high effectiveness, and so it continues to have durable OS and PFS in patients with NSCLC. And also an exploratory analysis assessed outcomes by 3 different PD-L1 expression levels, like 50% to 60%, 60% to 90%, and 90% and above, and cemiplimab showed to have the longer OS in all PD-L1 expression levels compared to chemotherapy.

It should be emphasized that the patients who had highest PD-L1 expression level of 90% or more [had] median OS reached in 39 months with a 5-year OS probability of 40%. In contrast with chemotherapy group, there were no differences between the different subgroups.

Pharmacy Times:What were the safety findings of the phase 2 EMPOWER-Lung 1 trial?

Baramidze: So, we reported safety for all patients who had at least 1 cycle of chemotherapy or 1 cycle of cemiplimab, and the safety results were consistent [with what] we have already reported previously. Treatment-emergent adverse events, regardless of attribution, grade 3 and above, occurred in 45% and 52% of patients treated with cemiplimab or chemotherapy, respectively. After addition of chemotherapy to the cemiplimab monotherapy in this treatment period, no new safety signals were detected, and grade 3 to 5 adverse events were detected in 36% of patients.

Pharmacy Times: What are some future directions for this research?

Baramidze: So, cemiplimab is already approved in US, Europe, and some other countries for the treatment of NSCLC with PD-L1 expression of 50% or more based on EMPOWER-Lung 1 results. But of course, we still continue analysis of the pivotal phase 3 study, and just to have the additional insights to help doctors to better understand how to treat the patients with high PD-L1 expression levels.

"The [WCLC] meeting was really filled with fascinating studies and data presentations." Image Credit: © Jon Benjamin Photography

Pharmacy Times: What were some notable presentations at the 2024 World Conference on Lung Cancer?

Baramidze: So, I can say that the meeting was really filled with fascinating studies and data presentations, and it's really hard to pick, but I think the most interesting part of this was, for me, the diversity of approaches. And I think that this diversity and the quality of presentations make the meeting a very enriching experience.