Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study

Abstract

Introduction: In the phase II ATLANTIC study, durvalumab provided durable responses with acceptable tolerability in heavily pretreated patients with advanced NSCLC, across three independent patient cohorts defined by EGFR/ALK status and tumour PD-Ll expression. Preliminary overall survival (OS) data were encouraging. We now report final OS and updated safety data. Methods: Patients with advanced NSCLC with disease progression following >= 2 previous systemic regimens received durvalumab 10 mg/kg every 2 weeks. The primary endpoint was objective response rate among patients with increased PD-L1 expression (defined as >= 25 % or >= 90 % of tumour cells [TCs], cohort-dependent). Secondary endpoints included OS and safety. Results: 444 patients received durvalumab: 111 in Cohort 1 (EGFR + /ALK +), 265 in Cohort 2 (EGFR - /ALK -), and 68 in Cohort 3 (EGFR - /ALK - ; TC >= 90 %). Median (95 % CI) OS was 13.3 months (6.3-24.5) in patients with EGFR + /ALK + NSCLC with TC >= 25 %, 10.9 months (8.6-13.6) in patients with EGFR-/ALK- NSCLC with TC >= 25 %, and 13.2 months (5.9-not reached) in patients with EGFR-/ALK- NSCLC with TC >= 90 %. Median (95 % CI) OS was slightly shorter in patients with TC < 25 % (9.9 months [4.2-13.3] in patients with EGFR+/ALK + NSCLC and 9.3 months [5.9-10.8] in those with EGFR-/ALK- NSCLC). Treatment-related adverse events of special interest occurred with similar incidences as reported previously. Conclusions: After additional follow-up, final OS data remain encouraging across all cohorts, further supporting the clinical activity of durvalumab in patients with heavily pretreated advanced NSCLC, including those with EGFR + /ALK + tumours. There were no new safety signals.