Abstract
High-dose alectinib for RET fusion-positive non-small cell lung cancer in the Blood First Assay Screening Trial
- 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
- F. Hoffmann-La Roche, Ltd., Welwyn Garden City, UK
- Genentech, Inc., South San Francisco, CA, USA
- F. Hoffmann-La Roche, Ltd., Basel, Switzerland
- Department of Internal Medicine, Henry Ford Cancer Institute/Henry Ford Health System, Detroit, MI, USA
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
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