High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial

Rafal Dziadziuszko; Nir Peled; Tony Mok; Solange Peters; Santiago Ponce Aix; Jorge Alatorre-Alexander; Brian D. Vicuna; Margaret Maclennan; Vijay Bhagawati-Prasad; Sarah M. Shagan; Erica Schleifman; Thorsten Ruf; Michael S. Mathisen; Shirish M. Gadgeel

doi:10.5114/wo.2023.135246

eISSN: 1897-4309
ISSN: 1428-2526

Contemporary Oncology/Współczesna Onkologia

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4/2023
vol. 27

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abstract:

Clinical research

High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial

Rafal Dziadziuszko

¹

,

Nir Peled

^{2, 3}

,

Tony Mok

⁴

,

Solange Peters

⁵

,

Santiago Ponce Aix

⁶

,

Jorge Alatorre-Alexander

⁷

,

Brian D. Vicuna

⁸

,

Margaret Maclennan

⁹

,

Vijay Bhagawati-Prasad

¹⁰

,

Sarah M. Shagan

¹¹

,

Erica Schleifman

¹¹

,

Thorsten Ruf

¹²

,

Michael S. Mathisen

¹¹

,

Shirish M. Gadgeel

¹³

Department of Oncology and Radiotherapy and Early Clinical Trials Centre, Medical University of Gdańsk, Gdańsk, Poland

Soroka Medical Centre and Ben-Gurion University, Beer-Sheeva, Israel

Helmsley Cancer Centre, Shaare Zedek Medical Centre, Hebrew University, Jerusalem, Israel (currently)

State Key Laboratory of Translational Oncology, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong

Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

Hospital Universitario 12 de Octubre, Madrid, Spain

Health Pharma Professional Research, Mexico City, Mexico

Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA

Syneos Health, Edinburgh, UK

10.

F. Hoffmann-La Roche, Ltd., Welwyn Garden City, UK

11.

Genentech, Inc., South San Francisco, CA, USA

12.

F. Hoffmann-La Roche, Ltd., Basel, Switzerland

13.

Department of Internal Medicine, Henry Ford Cancer Institute/Henry Ford Health System, Detroit, MI, USA

Contemp Oncol (Pozn) 2023; 27 (4): 217–223

DOI: https://doi.org/10.5114/wo.2023.135246

Online publish date: 2024/02/08

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AMA

Dziadziuszko R, Peled N, Mok T, et al. High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial. Contemporary Oncology/Współczesna Onkologia. 2023;27(4):217-223. doi:10.5114/wo.2023.135246.

APA

Dziadziuszko, R., Peled, N., Mok, T., Peters, S., Ponce Aix, S.,  & Alatorre-Alexander, J. et al. (2023). High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial. Contemporary Oncology/Współczesna Onkologia, 27(4), 217-223. https://doi.org/10.5114/wo.2023.135246

Chicago

Dziadziuszko, Rafal, Nir Peled, Tony Mok, Solange Peters, Santiago Ponce Aix, Jorge Alatorre-Alexander,  and Brian D. Vicuna et al. 2023. "High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial". Contemporary Oncology/Współczesna Onkologia 27 (4): 217-223. doi:10.5114/wo.2023.135246.

Harvard

Dziadziuszko, R., Peled, N., Mok, T., Peters, S., Ponce Aix, S., Alatorre-Alexander, J., Vicuna, B., Maclennan, M., Bhagawati-Prasad, V., Shagan, S., Schleifman, E., Ruf, T., Mathisen, M.,  and Gadgeel, S. (2023). High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial. Contemporary Oncology/Współczesna Onkologia, 27(4), pp.217-223. https://doi.org/10.5114/wo.2023.135246

MLA

Dziadziuszko, Rafal et al. "High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial." Contemporary Oncology/Współczesna Onkologia, vol. 27, no. 4, 2023, pp. 217-223. doi:10.5114/wo.2023.135246.

Vancouver

Dziadziuszko R, Peled N, Mok T, Peters S, Ponce Aix S, Alatorre-Alexander J et al. High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial. Contemporary Oncology/Współczesna Onkologia. 2023;27(4):217-223. doi:10.5114/wo.2023.135246.

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Introduction:
This paper presents results from Cohort B (rearranged during transfection [RET], fusion-positive) of the Blood First Assay Screening Trial in patients with advanced non-small cell lung cancer (NSCLC) screened for genetic alterations using blood-based next-generation sequencing.

Material and methods:
Adults with advanced RET fusion-positive NSCLC received alectinib 900 mg twice daily (BID) in Phase I. Enrolment closed prematurely with Phase II uninitiated.

Results:
Among eight treated patients, confirmed best overall responses in evaluable patients were stable disease (4/5) and progressive disease (1/5). One dose-limiting toxicity (death, unknown cause) was considered by the investigator to be related to treatment and underlying disease. Serious adverse events (SAEs) occurred in five patients, and SAEs that may be related to treatment occurred in two patients.

Conclusions:
Alectinib showed limited activity in advanced RET fusion-positive NSCLC, and further investigation was not conducted due to the development of selective RET inhibitors pralsetinib and selpercatinib. No new safety signals were observed, and the safety profile of alectinib was in line with previous reports at the 600 mg BID dose.

keywords:

alectinib, blood-based assay, Blood First Assay Screening Trial (BFAST), non small cell lung cancer, NSCLC, RET fusion, ctDNA, circulating tumour DNA, liquid biopsy, NGS