# Association Between Patient-Reported Outcomes and Overall Survival in Patients with Advanced NSCLC Treated with First-Line Cemiplimab-Based Therapy

## TL;DR

Improvements in patient-reported outcomes after treatment with cemiplimab for advanced lung cancer are linked to longer survival.

## Contribution

This study is the first to show that changes in patient-reported outcomes after treatment with cemiplimab correlate with survival in advanced NSCLC.

## Key findings

- A 56% reduction in risk of death was observed for improved global health status at 3 months.
- Every 10-point improvement in quality of life was linked to a 31% lower risk of death.
- Results were consistent across 3, 6, 9, and 12-month time points.

## Abstract

Patient-reported outcomes (PROs) are emerging as an important endpoint in clinical trials, facilitating interpretation and clinical application. Previous studies have examined the association between baseline PROs and overall survival, providing evidence for the potential prognostic value. However, limited research has investigated these associations in the context of immune checkpoint inhibitor treatment for advanced non-small-cell lung cancer, particularly regarding the relationship between changes from baseline in PROs and overall survival. To explore this relationship and its potential clinical relevance, the current study evaluated the association between sequential post-baseline PROs and overall survival in patients with advanced non-small-cell lung cancer who received first-line cemiplimab-based therapy.

Background/Objectives: Research on the association between change from baseline in patient-reported outcomes (PROs) and overall survival (OS) in patients with advanced non-small-cell lung cancer (NSCLC) exists. This study evaluated the association between post-baseline PROs and OS in patients with advanced NSCLC who received first-line cemiplimab-based therapy. Methods: We evaluated PRO data from two phase III studies (EMPOWER-Lung 1 [NCT03088540] and EMPOWER-Lung 3 [NCT03409614]) using a Cox proportional hazards model. Twelve pre-specified PRO scales from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Quality of Life Questionnaire Lung Cancer 13 module were evaluated. Landmark analyses were conducted at 3, 6, 9, and 12 months. Time-dependent analyses using change from baseline PROs as a time-dependent covariate were conducted to evaluate the association of post-baseline PRO improvement with OS. Results: At the 3-month landmark, we observed a 56% reduction in the risk of death (HR = 0.44; 95% CI: 0.32–0.62; nominal p < 0.0001) among stable/improved vs. worsened/unobserved PROs for global health status (GHS)/quality of life (QoL). Results at the 6-, 9-, and 12-month landmarks of GHS/QoL were consistent with those at the 3-month landmark. Time-dependent analyses showed that every 10-point improvement in GHS/QoL was associated with a 31% reduction in the risk of death (HR = 0.69; 95% CI: 0.64–0.75; nominal p < 0.0001). Conclusions: In patients with advanced NSCLC who received first-line cemiplimab-based therapy, improvements in post-baseline PROs are associated with improved OS. These results may inform endpoint selection and interpretation of future clinical trials.