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

Authors
 Marina Chiara Garassino  ;  Byoung-Chul Cho  ;  Joo-Hang Kim  ;  Julien Mazières  ;  Johan Vansteenkiste  ;  Hervé Lena  ;  Jesus Corral Jaime  ;  Jhanelle E Gray  ;  John Powderly  ;  Christos Chouaid  ;  Paolo Bidoli  ;  Paul Wheatley-Price  ;  Keunchil Park  ;  Ross A Soo  ;  Lynne Poole  ;  Catherine Wadsworth  ;  Phillip A Dennis  ;  Naiyer A Rizvi 
Citation
 LUNG CANCER, Vol.147 : 137-142, 2020-09 
Journal Title
 LUNG CANCER 
ISSN
 0169-5002 
Issue Date
2020-09
Keywords
ATLANTIC ; Durvalumab ; NSCLC ; Overall survival ; Safety
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. Trial registration: ClinicalTrials.gov NCT02087423.
Files in This Item:
T202003827.pdf Download
DOI
10.1016/j.lungcan.2020.06.032
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/180047
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