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A real world study of osimertinib: ASTRIS 2nd DCO Korean subgroup analysis

Date

24 Nov 2018

Session

Poster display - Cocktail

Presenters

Jong-Seok Lee

Citation

Annals of Oncology (2018) 29 (suppl_9): ix150-ix169. 10.1093/annonc/mdy425

Authors

J. Lee1, B.C. Cho2, D. Kim3, K. Park4, J.H. Kang5, S.S. Yoo6, S.Y. Lee7, C.H. Kim8, S.H. Jang9, Y.C. Kim10, H. Yoon11, S. Kim12

Author affiliations

  • 1 Oncology/hematology, Seoul National University Bundang Hospital, 463-707 - Seongnam/KR
  • 2 Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 3 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 4 Div. Of Heamatology/oncology, Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 5 Internal Medicine, The Catholic University of Korea, Seoul/KR
  • 6 Internal Medicine, Kyungpook National University, Daegu/KR
  • 7 Internal Medicine, Korea University Guro Hospital, Seoul/KR
  • 8 Internal Medicine, Koea Cancer Center Hospital, Ilsan/KR
  • 9 Internal Medicine, Hallym University Sacred Heart Hospital, Anyang/KR
  • 10 Internal Medicine, Chonnan National University Hwasun Hospital, Hwasun/KR
  • 11 Internal Medicine, The Catholic University of Korea, Yeouido St. Mary's hospital, Seoul/KR
  • 12 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
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Background

ASTRIS (NCT02474355) is a phase III, open-label, single-arm, multinational, real world study, investigating safety and efficacy of osimertinib in patients (pts) with T790M-positive advanced non-small cell lung cancer (NSCLC), who have previously received EGFR-TKI. As the largest real world study of osimertinib, ASTRIS has globally enrolled 3,014 pts; 466 were from Korea. We report the interim analysis (data cut-off (DCO): 20 Oct 2017) of Korean subset.

Methods

Eligible pts had advanced NSCLC with confirmed T790M mutation with no history of interstitial lung disease (ILD) or QTc prolongation. Pts with asymptomatic, stable CNS metastases were enrolled. Pts received osimertinib 80 mg once daily. The primary efficacy outcome was overall survival; other outcomes included investigator-assessed response rate (RR), progression-free survival (PFS), time to treatment discontinuation (TTD) and safety.

Results

A total of 466 pts received at least one dose of osimertinib from 31 Korean sites. Baseline pts’ characteristics were median age 61.2 (27–85) years, 47.4% had prior chemotherapy and 46.8% had prior radiotherapy. At DCO, 236 pts (50.6%) were ongoing and median follow-up time was 11.6 (0–18) months. 49.4% had treatment discontinuation; median duration of exposure 11.2 (0–19) months, 35.2% had disease progression and 19.7% died. In pts evaluable for response, defined as at least one dose of osimertinib and one response assessment, the investigator-assessed RR was 71.0% (320/451; 95% CI 66.5 – 75.1). Median PFS and TTD were 12.4 months (10.6-13.6 months) and 15months (12.7-16.5). Due to limited follow-up period, OS was immature to analyze. Adverse events (AEs) leading to dose modification including treatment discontinuation was reported in 12.0%. Serious AEs were reported in 24.9% and AEs leading to death were reported in 2.8%. ILD/pneumonitis-like events were reported in 1.7%, and QTc prolongation (>470ms) in 1.5%.

Conclusions

With additional follow-up, ASTRIS Korean subgroup continues to demonstrate similar clinical activities (RR) and safety to that observed in the other osimertinib clinical trials.

Editorial acknowledgement

Clinical trial identification

NCT02474355.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

All authors have declared no conflicts of interest.

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