Real-world ALK Testing Trends in Patients With Advanced Non-Small-Cell Lung Cancer in the United States

Area of Science:

• Oncology
• Biomarker Discovery
• Clinical Trials

Background:

• Anaplastic lymphoma kinase (ALK) rearrangements are key targets in non-small-cell lung cancer (NSCLC).
• ALK tyrosine kinase inhibitors offer effective treatment for patients with ALK-positive NSCLC.
• Understanding real-world biomarker testing and treatment patterns is crucial for optimizing patient care.

Purpose of the Study:

• To assess real-world anaplastic lymphoma kinase (ALK) biomarker testing patterns in US patients with non-small-cell lung cancer (NSCLC).
• To evaluate treatment strategies employed for NSCLC patients based on ALK rearrangement status.
• To identify trends in ALK testing methods and sample types over time.

Main Methods:

• Retrospective analysis of deidentified electronic health records from the Flatiron Health database (2011-2019).
• Inclusion criteria: patients aged ≥18 years with stage IIIB or IV NSCLC and ≥2 clinic visits.
• Extracted data on ALK testing rates, methods (FISH, NGS), sample types (tissue, blood), and treatment initiation relative to test results.

Main Results:

• Of 60,025 eligible NSCLC patients, 61.1% underwent ALK testing, with 2.8% testing positive (ALK+).
• ALK testing rates rose from 33.1% to 73.0% between 2011 and 2019, with a shift from FISH to next-generation sequencing (NGS).
• Blood sample testing increased significantly, and median time to ALK+ test results was 23 days; 24.7% of ALK+ patients started treatment before receiving results.

Conclusions:

• While ALK testing in NSCLC increased significantly, it remained suboptimal, falling short of 100% coverage.
• Treatment decisions for a notable proportion of NSCLC patients were made without essential biomarker information.
• There is a continued need to improve guideline-recommended biomarker testing rates to ensure appropriate, targeted therapy selection.