Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer (MYSTIC)

Abstract Background The phase 3 MYSTIC study of durvalumab ± tremelimumab versus chemotherapy in metastatic NSCLC patients with tumor cell (TC) PD-L1 expression ≥25% did not meet its primary endpoints. We report patient-reported outcomes (PROs). Patients and Methods Treatment-naive patients were randomized (1:1:1) to durvalumab, durvalumab + tremelimumab, or chemotherapy. PROs were assessed in patients with PD-L1 TC ≥25% using EORTC QLQ-C30/LC13. Changes-from-baseline (12 months) for pre-specified PRO endpoints of interest were analyzed by mixed-model-for-repeated-measures (MMRM) and time-to-deterioration (TTD) by stratified log-rank test. Results There were no between-arm differences in baseline PROs (N=488). Between-arm differences (99% CI) in MMRM-adjusted mean changes from baseline favored at least one of the durvalumab-containing arms versus chemotherapy (nominal P Conclusions Durvalumab ± tremelimumab versus chemotherapy reduced symptom burden and improved TTD of PROs, suggesting it had no detrimental effects on quality-of-life in metastatic NSCLC patients. Micro Abstract We investigated the impact of durvalumab ± tremelimumab, versus chemotherapy, on patient-reported symptoms, functioning, and global health status/QoL in the phase 3 MYSTIC trial of metastatic NSCLC in patients with tumor cell PD-L1 expression ≥25%. Durvalumab ± tremelimumab reduced symptom burden and improved times to deterioration, suggesting there were no detrimental effects with treatment.