Dr. Gadgeel on the Results of the BFAST Trial in ALK+ Lung Cancer

Shirish M. Gadgeel, MD, MBBS, Mary Lou Kennedy Research Professor in Thoracic Oncology, professor, Department of Internal Medicine, Division of Hematology/Oncology, co-leader, Thoracic Oncology Research Program, and associate director, Networking and Affiliated Centers, University of Michigan Medicine, discusses the results of the phase II/III BFAST trial in patients with ALK-positive lung cancer.

At the 2019 ESMO Congress, Gadgeel presented the results from the ALK-positive cohort of the BFAST trial. A total of 2,219 patients were screened; 87 were enrolled into the ALK cohort. The objective of the cohort was to compare the effectiveness of alectinib (Alecensa) in patients with ALK-positive disease identified by using blood-based next-generation sequencing (NGS) as opposed to tissue-based NGS.

According to the interim analysis, the investigator-assessed objective response rate with blood-based NGS was 87.4% (95% CI, 78.5%-93.5%), which compared favorably with the ORR observed with tissue-based NGS, which was 82.9% (71.7% confirmed) in the phase III ALEX trial. These data suggest that blood-based sequencing could be as effective as tissue-based sequencing in identifying effective targeted therapy for patients with targetable alterations. Additional cohorts of the trial are using the same design to evaluate targeted therapies based on the identification of RET positivity, ROS1 positivity, and high tumor mutational burden.