Treatment Characteristics and Real-World Progression-Free Survival in Patients with Unresectable Stage III NSCLC who Received Durvalumab After Chemoradiotherapy: Findings from the PACIFIC-R Study.

The Phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program (EAP). Here, we report treatment characteristics and a pre-planned analysis of real-world progression-free survival (rwPFS). PACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every-2-weeks) within an EAP between September-2017 and December-2018. The primary endpoints are investigator-assessed rwPFS and overall survival (analyzed by Kaplan-Meier method). As of November 30, 2020, the full analysis set comprised 1,399 patients from 11 countries (median follow-up duration, 23.5 months). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% CI: 19.1-24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 vs. 19.3 months) and among patients with programmed cell death-ligand 1 (PD-L1) expression ≥1% versus <1% (22.4 vs. 15.6 months). Overall, 16.5% of patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis/interstitial lung disease. Consolidation durvalumab following definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was higher among patients who received concurrent versus sequential CRT and patients with higher PD-L1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors