BFAST Trial Approved

Disease Target Area: Lung Cancer

About BFAST:

Assessment of actionable mutations in tissue from patients (pts) with advanced NSCLC is limited by invasive biopsies and the quality/quantity of tumor material. The Blood First Assay Screening Trial is Roche’s first blood-based screening trial and is an ongoing registrational, umbrella study evaluating the relationship between blood-based next-generation sequencing (NGS) detection of actionable genetic alterations in cell-free DNA, and the activity of targeted therapies and immunotherapy in treatment- naïve advanced/metastatic NSCLC.

About the Program & What we learned:

This innovative trial enrolling strictly based on blood-based testing addresses two main issues: low molecular testing rates and difficulty in running trials for rare mutations. The blood-based assay expands testing beyond those patients who have tissue biopsies, which can increase the overall testing rate and identification of patients who would likely benefit from targeted therapies. The umbrella trial can also enroll patients across different rare mutation types in one trial, reducing costs and inefficiencies of stand-alone trials. Positive topline results for Cohort A (ALK) were announced in August 2019, which demonstrate the utility of blood-based testing to identify patients and team’s approach in the study.

Reverse Translation:

In addition to the positive data readout, the genetic profiles of over 5000 patients have been collected via screening using the blood-based NGS assay, with over 500 patients enrolled on trial spread across four cohorts (as of August 2019). To our knowledge, this is also the first example of a collection of the genetic mutation profile of such a large sample size of patients, and the analysis of these may lead to further insight on treatment outcomes and mechanisms of resistance.