Chemotherapy Plus Cemiplimab Improves QOL vs Chemotherapy Alone in NSCLC

The addition of cemiplimab to platinum chemotherapy for non­–small cell lung cancer (NSCLC) was associated with improved patient quality of life (QOL) vs chemotherapy alone in an analysis of the EMPOWER‐Lung 3 trial. The findings were published in Cancer.¹

In the phase 3 EMPOWER-Lung 3 trial, cemiplimab demonstrated a survival benefit vs a placebo when added to platinum-based chemotherapy for NSCLC. These findings led to cemiplimab’s FDA approval for patients with advanced NSCLC with no EGFR, ALK, or ROS1 aberrations.² Considering the importance of QOL for patients undergoing treatment, the new analysis assessed patient‐reported outcomes (PROs) from the EMPOWER-Lung 3 population.

PROs were assessed at baseline and at the start of each 3-week treatment cycle during the study using 2 validated questionnaires: the European Organization for Research and Treatment of Cancer Quality of Life‐Core 30 (EORTC QLQ‐C30) and Quality of Life‐Lung Cancer Module. Researchers assessed changes in global health status and QOL subscales in the EORTC QLQ-C30.

A total of 312 patients received cemiplimab plus platinum doublet chemotherapy, while 154 received a placebo plus chemotherapy. Most patients were male (83.9%), and the median age in the overall cohort was 63 years.

A statistically significant improvement in pain symptoms was seen from baseline in patients in the cemiplimab-plus-chemotherapy cohort, with a score change of −4.98 (95% CI, −8.36 to −1.60; P = .004). There were significant delays in time to definitive clinically meaningful deterioration (TTD) in symptoms such as pain, dyspnea, constipation, nausea, and vomiting in the cemiplimab cohort compared with the placebo group.

There was an observed trend toward a delay in TTD of global health status in the cemiplimab group compared with the placebo group (HR, 0.78; 95% CI, 0.51-1.19; P = .248). Significant delays in TTD in functioning and symptom scales were also seen in the cemiplimab cohort vs the placebo group. This included symptoms such as cough, hemoptysis, and dysphagia.

“Despite 84.3% and 14.8% of patients in EMPOWER‐Lung 3 having ECOG [Eastern Cooperative Oncology Group] performance status of 1 and 0, respectively, the significant delay in TTD in these symptoms observed in EMPOWER‐Lung 3 further supports a clinically meaningful QOL benefit with cemiplimab plus chemotherapy,” the authors wrote.

Statistically significant overall global health status and QOL improvements from baseline were seen in the cemiplimab-plus-chemotherapy cohort, whereas there was a nonsignificant overall change in the placebo cohort.

None of the analyses demonstrated statistically significant improvements in PROs in the group receiving a placebo plus chemotherapy.

“The findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer,” study author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a statement.³

References

1. Makharadze T, Quek RGW, Melkadze T, et al. Quality of life with cemiplimab plus chemotherapy for first‐line treatment of advanced non–small cell lung cancer: Patient‐reported outcomes from phase 3 EMPOWER‐Lung 3. Cancer. Published online May 8, 2023. doi:10.1002/cncr.34687

2. FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer. News release. FDA. November 8, 2022. Accessed May 8, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-combination-platinum-based-chemotherapy-non-small-cell-lung-cancer

3. Immunotherapy plus chemotherapy combination for advanced lung cancer not only prolongs life but also improves its quality. News release. Wiley. May 8, 2023. Accessed May 8, 2023. https://newsroom.wiley.com/press-releases/press-release-details/2023/Immunotherapy-plus-chemotherapy-combination-for-advanced-lung-cancer-not-only-prolongs-life-but-also-improves-its-quality/default.aspx