Real-world use of osimertinib in non–small cell lung cancer: ASTRIS study Korean subgroup analysis

Abstract

Objective: ASTRIS is a large real-world, open-label, multinational clinical study of osimertinib in patients with epidermal growth factor receptor (EGFR) T790M mutation-positive advanced non-small cell lung cancer (NSCLC) who have previously received a tyrosine kinase inhibitor (TKI). We report data from the Korean ASTRIS subgroup.

Methods: Adult patients with locally advanced or metastatic NSCLC with a confirmed T790M mutation, WHO performance status of 0–2 and prior EGFR-TKI therapy, received osimertinib 80 mg once daily. Efficacy outcomes were overall survival (OS), investigator-assessed response rate (RR) and progression-free survival (PFS), and time to treatment discontinuation (TTD).

Results: At data cut-off (20 October 2017), 466 Korean patients were enrolled. Baseline EGFR molecular testing was mainly performed on biopsied tissue (75.1%). Baseline mutations co-occurring with T790M included exon 19 deletions (60.7%) and L858R (32.8%). 1-year OS was 82.7% (OS data not matured at data cut-off). Overall, RR was 71.0%, median PFS was 12.4 months and median TTD was 15.0 months. In patients with/without CNS metastases, RR was 68.0% and 79.6%, respectively; median PFS, 10.8 and 11.0 months, respectively; and median TTD, 11.2 and 14.7 months, respectively. Overall, 31.1% of patients experienced ≥1 adverse event (AE), leading to dose modification (12.0%), discontinuation (5.2%) or death (2.8%). Serious AEs (24.9%) included pulmonary embolism (1.7%), pleural effusion (1.7%), and pneumonia (1.5%).

Conclusion: In this real-world subgroup analysis of Korean patients in the ASTRIS study, osimertinib demonstrated comparable clinical efficacy to that attained in the global ASTRIS study and other clinical trials, with no new safety concerns.

Keywords:

• Osimertinib
• non–small cell lung cancer
• NSCLC
• EGFR T790M mutation
• EGFR-TKI therapy

Transparency

Declaration of funding

This work was supported by AstraZeneca Korea.

Declaration of financial/other relationships

BCC has received research funding from Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, and MSD; has acted in consulting roles for Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, and MSD; and has stock ownership in TheraCanVac Inc. SHJ is an advisory board member for AstraZeneca Korea. YCK has received research funding/honoraria from AstraZeneca. JYH has received honoraria from Roche, AstraZeneca, BMS, MSD, and Takeda; has acted in an advisory role for AstraZeneca, BMS, MSD, Lilly, Novartis, Pfizer, and Takeda; and has received research grants from Roche, Pfizer, and Ono. All other authors declare no conflicts of interest. CMRO peer reviewers on this manuscript have no conflicts of interest to disclose.

Acknowledgements

Medical writing and editorial support, under the direction of the authors, was provided by Robert A. Furlong, Ph.D. and David P. Figgitt, Ph.D., ISMPP CMPP, Content Ed Net, with funding from AstraZeneca Korea.