190TiP - ELUXA 1: Phase II study of BI 1482694 (HM61713) in patients (pts) with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an ep...

Date 15 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session Poster lunch
Topics Clinical research
Non-small-cell lung cancer
Basic Scientific Principles
Presenter Keunchil Park
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors K. Park1, J. Han2, D. Kim3, L.A. Bazhenova4, S. Ou5, Y. Pang6, H.S. Hin7, O. Juan8, J. Son9, P. Jänne10
  • 1Samsung Medical Center, Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 2Center For Lung Cancer, National Cancer Center, Goyang/KR
  • 3Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 4Department Of Medicine, University of California San Diego Moores Cancer Center, 92093 - La Jolla/US
  • 5Department Of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange/US
  • 6Department Of Medicine, University of Malaya, Kuala Lumpur/MY
  • 7Department Of Internal Medicine, International Islamic University Malaysia, Pahang/MY
  • 8Servicio De Oncología, Hospital Universitari i Politècnic La Fe, Valencia/ES
  • 9R&d, Hanmi Pharmaceutical Co., Seoul/KR
  • 10Department Of Medical Oncology, Dana-Farber Cancer Institute, Boston/US

Abstract

Background

BI 1482694 (HM61713) is an oral EGFR mutant-specific TKI which has shown encouraging clinical activity as well as favourable tolerability in pts with EGFR TKI pre-treated NSCLC harbouring a T790M mutation. A clinical programme has been initiated to evaluate BI 1482694 in various NSCLC treatment settings. This global Phase II trial is designed to further investigate the efficacy and safety of BI 1482694 in pts with NSCLC and acquired T790M-mediated resistance to first-line EGFR TKIs.

Trial design

This is an ongoing, single-arm, open-label, Phase II trial enrolling adult pts (≥20 years) with locally advanced or metastatic EGFR mutated NSCLC, disease progression following EGFR TKI therapy with or without additional lines of chemotherapy, centrally confirmed T790M-positivity in the tumour prior to study entry, and ECOG PS 0/1. Pts should not have received chemotherapy, hormonal therapy, or immunotherapy within 14 days, EGFR TKIs (including erlotinib, gefitinib, afatinib) within 10 days or 5-fold half-life, whichever is the longer, or any investigational agents within 28 days prior to study drug administration. Prior treatment with drugs targeting T790M mutants (e.g., AZD9291, CO-1686) is not allowed. Pts will receive oral BI 1482694 800 mg, with dose modification if required, once daily in 21-day cycles until disease progression, unacceptable toxicity, withdrawal or death. The primary endpoint is objective response rate according to RECIST v1.1 (independent central review). Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, time to progression, tumour shrinkage, pt-reported outcomes, safety, and pharmacokinetics of BI 1482694. This trial was initiated in June 2015 and is currently recruiting pts in Republic of Korea, Malaysia, Philippines, Italy, Spain, Taiwan and the USA. Additional study locations will include Australia, Canada, and Germany, with an estimated total enrolment of 150 pts. Further details are available at ClinicalTrials.gov (NCT02485652).

Clinical trial identification

NCT02485652

Legal entity responsible for the study

Hanmi Pharmaceuticals

Funding

Hanmi Pharmaceuticals in collaboration with Boehring­er Ingelheim

Disclosure

K. Park: Advisory board: AZ, BI, Clovis, Eli Lilly, Hanmi, Novartis, Ono, Roche. S.-H. Ou: Advisory board: BI, AZ, Roche Corporate-sponsored research: BI, AZ, Roche, Clovis Honoraria: BI, Roche. J. Son: Employment: Hanmi Pharmaceutical. P. Jänne: Stock ownership/options: Gatekeeper pharmaceuticals Advisory board: AZ, Pfizer, Roche, Ariad Corporate-sponsored research: AZ, Astellas Other: LabCorp – post marketing royalties on DFCI owned patent on EGFR mutations. All other authors have declared no conflicts of interest.