Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: the phase II ATLANTIC study
Mené sur 444 patients atteints d’un cancer du poumon non à petites cellules de stade avancé, cet essai de phase II évalue l’efficacité, du point de vue de la survie globale, et la toxicité du durvalumab en traitement de troisième ligne ou au-delà
Résumé en anglais
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-L1 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.
