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Poster Display session 1

5751 - Phase 3 ALTA-3 study of brigatinib (BRG) vs alectinib (ALC) in patients (pts) with advanced anaplastic lymphoma kinase (ALK)−positive non–small cell lung cancer (NSCLC) that progressed on crizotinib (CRZ)

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Sanjay Popat

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

S. Popat1, G. Liu2, S. Lu3, G. Song4, V. Samnotra5, J.C. Yang6

Author affiliations

  • 1 Medicine, Royal Marsden Hospital Fulham Road, SW3 6JJ - London/GB
  • 2 Ontario Cancer Institute, Princess Margaret Cancer Centre, Toronto/CA
  • 3 Medical Oncology, Shanghai Chest Hospital, Shanghai/CN
  • 4 Biostatistics, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge/US
  • 5 Clinical Research, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge/US
  • 6 Department Of Oncology, National Taiwan University Hospital, Taipei/TW

Resources

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Abstract 5751

Background

The second-generation ALK tyrosine kinase inhibitor (TKI) ALC has demonstrated efficacy and acceptable safety in ALK+ NSCLC pts who have progressed on CRZ. However, resistance to ALC eventually develops, with secondary resistance mutations detected in approximately 50% of pts and a median progression-free survival (PFS) <1 year. BRG is a next-generation ALK TKI designed to have potent and broad activity against ALK mutants. Post-CRZ, BRG demonstrated high systemic and central nervous system (CNS) objective response rates (ORRs) and the longest reported median PFS of any ALK inhibitor in this setting (16.3–16.7 mo) (Huber. J Clin Oncol 2018;36; Bazhenova. Ann Oncol 2017;28). The current trial was designed to compare efficacy and safety of BRG vs ALC in pts with ALK+ NSCLC that has progressed on CRZ.

Trial design

The second-generation ALK tyrosine kinase inhibitor (TKI) ALC has demonstrated efficacy and acceptable safety in ALK+ NSCLC pts who have progressed on CRZ. However, resistance to ALC eventually develops, with secondary resistance mutations detected in approximately 50% of pts and a median progression-free survival (PFS) <1 year. BRG is a next-generation ALK TKI designed to have potent and broad activity against ALK mutants. Post-CRZ, BRG demonstrated high systemic and central nervous system (CNS) objective response rates (ORRs) and the longest reported median PFS of any ALK inhibitor in this setting (16.3–16.7 mo) (Huber. J Clin Oncol 2018;36; Bazhenova. Ann Oncol 2017;28). The current trial was designed to compare efficacy and safety of BRG vs ALC in pts with ALK+ NSCLC that has progressed on CRZ.Table:

1586TiP

Primary Endpoint
Blinded independent review committee (BIRC)−assessed PFS per RECIST v1.1
Secondary Endpoints
BIRC-assessed intracranial PFS Overall survival Investigator- and BIRC-assessed ORR, time to response, and duration of response (DOR) BIRC-assessed intracranial ORR and DOR Safety/tolerability Health-related quality of life
Selected Exploratory Endpoints
BIRC-assessed CNS efficacy per Response Assessment in Neuro-Oncology Brain Metastases criteria (intracranial ORR, DOR, and PFS) Molecular determinants of efficacy and safety with BRG and ALC

Clinical trial identification

NCT03596866.

Editorial acknowledgement

Peloton Advantage, LLC, an OPEN Health Company; funded by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Legal entity responsible for the study

ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Funding

ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Disclosure

S. Popat: Research grant / Funding (institution): Boehringer Ingelheim, Epizyme, BMS, Clovis Oncology, Roche, Lilly, Takeda; Honoraria (self): Boehringer Ingelheim, AstraZeneca, Roche, Takeda, Chugai Pharma; Advisory / Consultancy: Boehringer Ingelheim, Roche, Novartis, Pfizer, AstraZeneca, BMS, MSD, Guardant Health, AbbVie; Travel / Accommodation / Expenses: Boehringer Ingelheim, BMS, Merck Sharp & Dohme. G. Liu: Research grant / Funding (institution): Takeda, AstraZeneca, Roche, Bayer, Boehringer Ingerheim; Honoraria (self): Roche, Takeda, AstraZeneca, Bristol-Myers Squibb, AbbVie, Pfizer, Merck,Novartis, EMD Serano, Bayer; Advisory / Consultancy: Roche, Novartis, Pfizer. S. Lu: Advisory / Consultancy: AstraZeneca, Boehringer Ingelheim, Hutchison MediPharma, Simcere, Roche, JS InnoPharm; Speaker Bureau / Expert testimony: AstraZeneca, Roche; Research grant / Funding (self): AstraZeneca, Hutchison MediPharma. G. Song: Full / Part-time employment: Takeda. V. Samnotra: Full / Part-time employment: Takeda. J.C. Yang: Advisory / Consultancy: Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Celgene, Merrimack, Yuhan Pharmaceuticals, BMS, Ono Pharmaceutical, Daiichi Sankyo, Takeda, AstraZeneca, Hansoh Pharmaceuticals.

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