KEY TAKEAWAYS
- The phase 3 trial aimed to perform the exploratory analyses to assess PROs specifically in the advanced NSCLC patients.
- The results demonstrated that combining CEMI with CHEMO significantly improves QoL compared to CHEMO alone in advanced NSCLC patients with liver metastases.
In the EMPOWER-lung 3 trial (NCT03409614), a double-blinded, randomized phase 3 study, cemiplimab + chemotherapy demonstrated improved overall survival (OS) compared to placebo + chemotherapy in advanced non-small cell lung cancer NSCLC patients with baseline liver metastases (median OS: 14.4 vs 8.9 months; HR: 0.61 [95% CI: 0.31, 1.20]). Safety outcomes in this subgroup were consistent with the overall study population.”
Ana Baramidze and her team aimed to present the exploratory analyses considering the impact of cemiplimab + chemotherapy (CEMI+CHEMO, n=47) compared to placebo + chemotherapy (CHEMO,n=23) on OS in patients with baseline liver metastases from advanced NSCLC.
In this study, patient-reported outcomes (PROs) were systematically assessed at various time points, including baseline and throughout treatment cycles, utilizing the EORTC-QLQ-C30 and -QLQ-LC13 questionnaires. A comprehensive analysis, employing a mixed-effect model for repeated measures, was conducted to compare CEMI+CHEMO versus CHEMO across all scales. Time to definitive clinically meaningful deterioration (TTD) was meticulously examined through Kaplan-Meier analysis, with between-arm comparisons facilitated by log-rank tests and proportional hazards models.
The study employed rigorous methods to assess PROs in advanced NSCLC patients with baseline liver metastases. PROs were systematically evaluated at day 1 (baseline), the initiation of each 3-week treatment cycle for the initial 6 doses, and subsequently at the commencement of every third cycle.
Utilizing the EORTC-QLQ-C30 and -QLQ-LC13 questionnaires, a mixed-effect model for repeated measures analysis was applied to compare CEMI+CHEMO vs CHEMO across all scales. TTD was meticulously examined through Kaplan-Meier analysis, with between-arm TTD comparisons conducted using a log-rank test and proportional hazards model.
The results demonstrated a statistically significant delay in TTD compared to CHEMO for role functioning (HR: 0.28, 95% CI [0.10, 0.79]; P=0.011), cognitive functioning (HR: 0.18, [0.06, 0.55]; P=0.001), haemoptysis (HR <0.01, [ <0.01, not calculable]; P=0.021), and alopecia (HR: 0.25, [0.09, 0.72]; P=0.007). Between-arm comparisons showed no statistically significant differences in overall change from baseline across all C30 or LC13 scales. No analyses revealed statistically significant PRO results favoring CHEMO vs CEMI+CHEMO for any C30 or LC13 scales.
The reported data supported that CEMI+CHEMO significantly delays TTD in key aspects such as role functioning, cognitive functioning, haemoptysis, and alopecia, when compared to CHEMO in baseline liver metastases patients from advanced NSCLC.
The overall maintenance of favorable changes from baseline across all PROs further solidifies the compelling benefit–risk profile of CEMI+CHEMO over CHEMO in advanced NSCLC with baseline liver metastases. The study is sponsored by Regeneron Pharmaceuticals.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34
Clinical Trial: https://clinicaltrials.gov/study/NCT03409614
Baramidze A, et al. (2023).”Patient-reported outcomes (PROs) of cemiplimab + chemotherapy in advanced non-small cell lung cancer (NSCLC): EMPOWER-lung 3 liver metastases subpopulation”. Presented at ESMO-IO 2023 (Abstract 75P)
