Marina Chiara Garassino1, Byoung-Chul Cho2, Joo-Hang Kim3, Julien Mazières4, Johan Vansteenkiste5, Hervé Lena6, Jesus Corral Jaime7, Jhanelle E Gray8, John Powderly9, Christos Chouaid10, Paolo Bidoli11, Paul Wheatley-Price12, Keunchil Park13, Ross A Soo14, Lynne Poole15, Catherine Wadsworth16, Phillip A Dennis17, Naiyer A Rizvi18. 1. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: marina.garassino@istitutotumori.mi.it. 2. Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea. 3. CHA Bundang Medical Center, CHA University, Gyeonggi-do, South Korea. 4. Toulouse University Hospital, Université Paul Sabatier, Toulouse, France. 5. University Hospitals KU Leuven, Leuven, Belgium. 6. CHU Rennes-Hôpital Pontchaillou, Rennes University, Rennes, France. 7. Hospital Universitario Virgen del Rocio, Seville, Spain. 8. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. 9. Carolina BioOncology Institute, Huntersville, NC, USA. 10. Centre Hospitalier Intercommunal de Créteil, Créteil, France. 11. Azienda Ospedaliera San Gerardo, Monza, Italy. 12. The Ottawa Hospital Research Institute/University of Ottawa, Ottawa, ON, Canada. 13. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 14. National University Hospital and National University Cancer Institute, Singapore. 15. AstraZeneca, Cambridge, UK. 16. AstraZeneca, Alderley Park, UK. 17. AstraZeneca, Gaithersburg, MD, USA. 18. Columbia University Medical Center, New York, NY, USA.
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-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.
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 tumourPD-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.