The Journal of Clinical Pathways spoke with Ticiana Leal, MD, Winship Cancer Institute at Emory University, about the findings from her study entitled “ALK testing patterns in early-stage non-small cell lung cancer: A real-world evidence study,” which was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Please introduce yourself by stating your name, title, organization, and relevant professional experience.

I'm Dr Ticiana Leal. I'm an associate professor and director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University in Atlanta, Georgia.

Can you give some background about your study and what prompted you to undertake it?

We presented this study as a poster at the 2024 ASCO Annual Meeting. We performed a real-world evidence study to look at anaplastic lymphoma kinase (ALK) testing patterns in patients with early-stage non–small cell lung cancer (NSCLC).

What prompted this investigation were recent developments in the importance of biomarker testing. Although this is standard of care in advanced NSCLC, testing is not done consistently, including for patients with advanced disease. With approvals of targeted therapy in patients with early-stage NSCLC it’s important to identify the current rate of ALK testing for patients.

Alectinib is approved for patients with resected early-stage NSCLC that have an ALK fusion or rearrangement detected by a US Food and Drug Administration-approved test. Our study was designed to evaluate the rate of ALK testing in patients with early-stage NSCLC and to identify factors associated with timely receipt of ALK testing prior to the approval of alectinib for this indication.

Can you briefly describe how the study was conducted?

Our study was a retrospective analysis of the deidentified Flatiron Health electronic health record (EHR)-derived database. We performed an analysis of patients with resected stage I to IIIA NSCLC who were diagnosed between 2018 and 2023 and did not have ALK testing results before initial diagnosis. We looked at the primary outcome of ALK testing by any modality within 90 days of initial diagnosis. We performed a multivariable logistic regression and used that to assess the association between patient characteristics and the likelihood of ALK testing within 90 days of initial diagnosis.

What were the main findings of your study?

The main finding of our study is that the majority of patients did not have ALK testing done in a timely fashion. We had a total of 24 076 patients with resected stage I to IIIA NSCLC that met all the eligibility criteria for inclusion in the study. Of the patients included 31% were tested within 90 days of initial diagnosis and 69% were not. Fourteen percent were tested before their lung cancer surgery and 9% were tested more than 90 days after diagnosis.

We also looked at testing patterns. Patients were more likely to be tested within 90 days if they had a more recent diagnosis (between 2021 and 2023 vs 2018), more advanced disease (stages II and IIIA), no history of smoking, Medicaid vs commercial insurance, higher socioeconomic status, and treatment in a community setting. In our database, we didn't see any significant differences between Black and White patients, but patients of other races—including Hispanic/Latino—were more likely to be tested.

Patients who were less likely to receive ALK testing within 90 days of initial diagnosis included those with squamous histology, those with Medicare vs commercial insurance, and residents of the Northeast or West vs the Midwest.

One important finding that we also identified was that in general, the rate of ALK testing within 90 days of initial diagnosis increased over time across all of the stages, with a more noticeable increase in patients with stage II and IIIA NSCLC.

Looking ahead, what potential impact do you hope your findings will have on ALK testing in the standard of care for patients with eNSCLC?

It's important to note that our study was conducted in a retrospective fashion looking at rates and patterns of ALK testing prior to the approval of ALK-targeted therapy in patients with early-stage NSCLC. It's encouraging that we saw an increase in rates of testing over time in more recent data.

However, our study is relevant because we're identifying potential gaps in testing. And it's important that we address these gaps right away so that we can identify patients that have less likelihood of receiving ALK testing  up front and educate patients, providers, and payers to help prevent or minimize these disparities in ALK testing. That way patients can have access to optimal targeted therapy and improved outcomes.