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Proffered Paper 2 - NSCLC, metastatic

5026 - Phase II/III Blood First Assay Screening Trial (BFAST) in patients (pts) with treatment-naïve NSCLC: initial results from the ALK+ cohort

Date

30 Sep 2019

Session

Proffered Paper 2 - NSCLC, metastatic

Presenters

Shirish Gadgeel

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

S.M. Gadgeel1, T.S.K. Mok2, S. Peters3, J.A.A. Alexander4, N.B. Leighl5, V. Sriuranpong6, M. Perol7, G. De Castro Jr.8, E. Nadal9, F. De Marinis10, J. Han11, M. Yan12, T. Riehl13, E. Schleifman13, S.M. Paul13, S. Mocci13, D. Shames13, M.S. Mathisen13, R. Dziadziuszko14

Author affiliations

  • 1 Department Of Internal Medicine, Rogel Cancer Center, University of Michigan, 48104-3209 - Ann Arbor/US
  • 2 State Key Laboratory Of Translational Oncology, The Chinese University of Hong Kong, Shatin/HK
  • 3 Multidisciplinary Oncology Center, University Hospital of Vaudois (CHUV), 1011 - Lausanne/CH
  • 4 Clínica De Oncología Torácica, Health Pharma Professional Research, New Mexico/MX
  • 5 Cancer Clinical Research Unit (ccru), Princess Margaret Cancer Centre, M5G 2C1 - Toronto/CA
  • 6 Medical Oncology Unit, King Chulalongkorn Memorial Hospital, 10330 - Bangkok/TH
  • 7 Department Of Medical Oncology, Léon Bérard Cancer Center, 69008 - Lyon/FR
  • 8 Clinical Oncology, Cancer Institute of Sao Paulo, 01246-000 - Sao Paulo/BR
  • 9 Catalan Institute Of Oncology, L'Hospitalet, 08907 - Barcelona/ES
  • 10 Irccs, European Institute of Oncology, Milan/IT
  • 11 Medical Oncology, National Cancer Center, Goyang/KR
  • 12 Medical Oncology, F. Hoffmann-La Roche, Mississauga/CA
  • 13 Product Development Oncology, Genentech Inc.,, South San Francisco/US
  • 14 Department Of Oncology And Radiotherapy, Medical University of Gdansk, Gdansk/PL
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Resources

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Abstract 5026

Background

Tissue-based assessment of actionable mutations in pts with NSCLC is limited by invasive biopsies and adequacy of biopsied tumour material. Blood-based testing may overcome such limitations, allowing multiplex profiling in a single test. BFAST (NCT03178552) is an ongoing multicentre, open-label, multi-cohort study evaluating the relationship between blood-based next-generation sequencing (NGS) detection of actionable genetic alterations in cell-free DNA, and the activity of targeted therapies and immunotherapy in pts with treatment-naïve advanced NSCLC. We present first results from the ALK+ cohort.

Methods

Pts ≥18 years with stage IIIB/IV ALK+ NSCLC (detected by blood-based NGS) received oral alectinib 600mg twice daily. Asymptomatic/treated central nervous system (CNS) metastases were permitted. All pts (with/without CNS disease) had 8-weekly restaging and brain scans. Primary endpoint: confirmed investigator (INV)-assessed objective response rate (ORR; RECIST v1.1). Key secondary endpoints: independent review facility (IRF)-assessed ORR; INV- and IRF-assessed duration of response (DoR), progression-free survival (PFS), overall survival; and safety.

Results

Of 2,219 pts screened, blood-based NGS yielded results in 2,188 pts. Overall, 119 pts (5.4%) had ALK+ disease; 87 pts were enrolled and received alectinib. EML4 was the fusion partner in 73 (84%) pts, with TP53 mutations detected in 38 (44%) pts. Median blood-based tumour mutational burden was 2 (range, 0–21). Median follow-up: 12.6 months (range, 2.6–18.7). Confirmed ORR: 87.4% (95% CI 78.5–93.5) by INV and 92.0% (95% CI 84.1–96.7) by IRF. The 12-month INV-confirmed DoR was 75.9% (95% CI 63.6–88.2). In 35 (40%) pts with asymptomatic baseline CNS disease, ORR by INV was 91.4% (95% CI 76.9–98.2). Median PFS: not reached; 12-month PFS by INV was 78.4% (95% CI 69.1–87.7). Safety data were consistent with the known safety profile of alectinib.

Conclusions

Blood-based detection of ALK fusions results in high ORR and clinical benefit in pts receiving alectinib. These data validate the clinical utility of blood-based NGS as an additional method to inform clinical decision-making in ALK+ NSCLC.

Clinical trial identification

NCT03178552.

Editorial acknowledgement

Medical Writing support was provided by Nicola Griffin of Gardiner-Caldwell Communications and funded by F. Hoffmann-La Roche.

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffman-La Roche Ltd.

Disclosure

S.M. Gadgeel: Honoraria (self), Advisory / Consultancy: Ariad, AstraZeneca, Bristol-Myers Squibb, Pfizer and F. Hoffmann-La Roche Ltd/Genentech. T.S.K. Mok: Leadership role: Sanonics Ltd; Honoraria (self), Advisory / Consultancy: ACEA Biosciences, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chimed, Cirina, Fishawack Facilitate, Ignyta, Janssen, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, OncoGenex, Pfizer, F. Hoffmann-La Roche Ltd/Genentech, SFJ Pharm; Research grant / Funding (self): AstraZeneca, Bristol-Myers Squibb, Clovis Oncology, Merck Sharp & Dohme, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, SFJ Pharmaceutical and XCovery. S. Peters: Honoraria (self), Advisory / Consultancy: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Eli Lilly, F. Hoffmann-La Roche Ltd, Janssen, Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Regeneron and Takeda; Speaker Bureau / Expert testimony: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme, Novartis and Pfizer. J.A.A. Alexander: Honoraria (self), Advisory / Consultancy: AstraZeneca, Boehringer Ingelheim Bristol-Myers Squibb, Pfizer and F. Hoffmann-La Roche Ltd/Genentech, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Takeda. N.B. Leighl: Research grant / Funding (self): F. Hoffmann-La Roche, Array, Guardant and AstraZeneca; Honoraria (self): AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, F. Hoffmann-Lar Roche, Pfizer ; Advisory / Consultancy: Excovery. V. Sriuranpong: Honoraria (self), Advisory / Consultancy: AstraZeneca, Novartis, F. Hoffmann-La Roche Ltd, Pfizer, Sanofi, Eisai, Boehringer, Taiho, Merck Sharp & Dohme, Bristol-Myers Squibb ; Research grant / Funding (institution): AstraZeneca, Novartis, F. Hoffmann-La Roche Ltd, Pfizer, Boehringer, Eisai, Taiho, Lilly and Merck Sharp & Dohme. M. Perol: Honoraria (self): F. Hoffmann-La Roche Ltd, AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Takeda, Chugai, Boehringer Ingelheim, Eli Lilly, Amgen and AbbVie. G. De Castro Jr.: Advisory / Consultancy: AstraZeneca, Merck Sharp & Dohme, Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd, Novartis, Boehringer Ingelheim, Pfizer, Bayer; Speaker Bureau / Expert testimony: Merck Sharp & Dohme, Bristol-Myers Squibb, Novartis, AstraZeneca, Pfizer, F. Hoffmann-La Roche Ltd, Bayer, TEVA ; Travel / Accommodation / Expenses: Merck Sharp & Dohme, Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd, Bayer, Novartis, Boehringer Ingelheim, AstraZeneca, Pfizer and Bayer.. E. Nadal: Honoraria (self), Advisory / Consultancy: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd, Janssen, Merck Sharp & Dohme, Pfizer and Takeda. F. De Marinis: Honoraria (self): F. Hoffmann La Roche Ltd, Bristol-Myers Squibb, AstraZeneca and Merck. J. Han: Honoraria (self): Roche, AstraZeneca, BMS, MSD, Takeda; Advisory / Consultancy: AstraZeneca, BMS, MSD, Lilly, Novartis, Pfizer, Takeda; Research grant / Funding (self): Roche, Pfizer, ONO . M. Yan: Full / Part-time employment: F. Hoffmann-La Roche Ltd.. T. Riehl: Full / Part-time employment: Genentech, Inc. E. Schleifman: Full / Part-time employment: Genentech, Inc. S.M. Paul: Full / Part-time employment: Genentech, Inc. S. Mocci: Full / Part-time employment: Genentech, Inc. D. Shames: Full / Part-time employment: Genentech, Inc. M.S. Mathisen: Full / Part-time employment: Genentech, Inc. R. Dziadziuszko: Honoraria (self), Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Pfizer, Boehringer Ingelheim, Clovis Oncology, Novartis, AstraZeneca and Tesaro..

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