468P - Osimertinib in patients with T790M mutation positive advanced non-small cell lung cancer (NSCLC): Korean subgroup analysis from pooled phase II data

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Cytotoxic agents
Biomarkers
Non-Small-Cell Lung Cancer, Metastatic
Presenter Myung-Ju Ahn
Citation Annals of Oncology (2016) 27 (suppl_9): ix139-ix156. 10.1093/annonc/mdw594
Authors M. Ahn1, J. Lee2, J. Han3, D. Kim4, B.C. Cho5, J.H. Kang6, S. Kim7
  • 1Section Of Hematology-oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 2Division Of Hematology-oncology, Seoul National University Bundang Hospital, 13620 - Gyeonggi-do/KR
  • 3Lung Cancer Branch, Research Institute And Hospital, National Cancer Center, 10408 - Gyeonggi-do/KR
  • 4Department Of Internal Medicine, Seoul National University Hospital, 03080 - Seoul/KR
  • 5Division Of Medical Oncology, Yonsei Cancer Center, 13722 - Seoul/KR
  • 6Department Of Medical Oncology, Seoul St. Mary's Hospital, 137-701 - Seoul/KR
  • 7Department Of Oncology, Asan Medical Center, 05505 - Seoul/KR

Abstract

Background

Osimertinib is a potent, selective, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), selective for both EGFR-sensitizing and T790M resistance mutations. This is the results of a Korean subgroup analysis from a pooled analysis of two global phase II studies in pre-treated patients: AURA extension (NCT01802632) and AURA2 (NCT02094261).

Methods

Both studies enrolled patients with EGFR/T790M mutation-positive NSCLC who had progressed on or after EGFR TKI therapy. Patients were treated with osimertinib 80 mg orally QD until disease progression. Objective response rate (ORR) was the primary endpoint; duration of response (DoR) and progression-free survival (PFS) were the secondary endpoints. Data cut-off (DCO) was 1 November 2015; results from 411 patients in the global study have been presented previously.

Results

A total of 66 Korean patients were dosed; median age 60.5 years; 69.7% female; 72.7% never smokers. The median duration of exposure to osimertinib was 13.3 months. Confirmed ORR in the evaluable-for-response population (N = 62) by blinded independent central review was 76% (47/62; 95% confidence interval [CI]: 63, 86). Median DoR was 11.0 months (95% CI: 8.3, not calculable [NC]) and median PFS was 11.0 months (95% CI: 8.3, NC). The results are comparable to the global study population; ORR 66% (262/397, 95% CI: 61, 71), median DoR 12.5 months (95% CI: 11.1, NC), median PFS 11.0 months (95% CI: 9.6, 12.4). The most common causality-related adverse events (AEs) were rash (grouped term) (44%, 0% Grade ≥3), pruritus (27%; 0% Grade ≥3), and paronychia (grouped term) (26%; 0% Grade ≥3); 5 (7.6%) patients experienced Grade ≥3 AEs.

Conclusions

Overall efficacy and tolerability with osimertinib in this Korean subset was consistent with results from the global study. Osimertinib provides a high ORR, with encouraging DoR and PFS, and a manageable tolerability profile.

Clinical trial indentification

Clinical trial registration number: NCT01802632, NCT02094261

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

M-J. Ahn, D-W. Kim: All authors participated in either AURA extension (NCT01802632) or AURA2 (NCT02094261) study as investigators. This author is one of the investigators of AURA extension (NCT01802632) study and other company-sponsored clinical trials. J-S. Lee, J-Y. Han: All authors participated in either AURA extension (NCT01802632) or AURA2 (NCT02094261) study as investigators. This author is one of the investigators of AURA2 (NCT02094261) study and other company-sponsored clinical trials. B.C. Cho, S-W. Kim: All authors participated in either AURA extension (NCT01802632) or AURA2 (NCT02094261) study as investigators. This author is one of the investigators of AURA extension (NCT01802632) study and other company-sponsored clinical trials. J.H. Kang: All authors participated in either AURA extension (NCT01802632) or AURA2 (NCT02094261) study as investigators. This author is one of the investigators of AURA2 (NCT02094261) study and other company-sponsored clinical trials.