The efficacy of Alecensa (alectinib) in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, who were identified using liquid biopsy in the phase II/III BFAST study, is consistent with efficacy in those identified by tissue analysis in the phase III ALEX study.
Genentech, a member of the Roche Group, sponsors the BFAST trial. The BFAST trial was the first prospective study to use only blood-based next generation sequencing to detect specific fusions with the aim of selecting treatment for people with NSCLC, without the need for tissue biopsy. The positive results came from a single-arm cohort.
Results from the ALK cohort were presented at ESMO Sept. 30.
“Obtaining tumor tissue for biomarker testing can be a challenge in many people with cancer and, as a result, some may not receive optimal treatment for their disease,” Sandra Horning, Chief Medical Officer and head of Global Product Development at Roche/Genentech, said in a statement. “BFAST is the first trial to show that by using a blood-based next-generation diagnostic, it is possible to identify the ALK mutation in people with non-small cell lung cancer using a blood draw alone, which means that more people could potentially benefit from Alecensa.”
Foundation Medicine partnered with Roche/Genentech on the study.
“Validated and comprehensive liquid biopsy tests are critical to help physicians find the best possible treatment approach for patients with advanced cancer and for whom tissue testing isn’t feasible,” Chief Medical Officer of Foundation Medicine, Brian Alexander, said in a statement. “Identifying ALK fusions can be particularly challenging and these data demonstrate that FoundationOne Liquid can accurately predict which patients can respond to therapy.”
The BFAST study used FoundationOne Liquid, Foundation Medicine’s liquid biopsy test, which detects the four main classes of genomic alterations, microsatellite instability and select fusions including ALK in circulating tumor DNA from a blood draw.
These data demonstrate that the FoundationOne Liquid assay can help test and identify a broader population of people with advanced NSCLC who may benefit from Alecensa, for whom current diagnostic tests are not suitable, such as for those who cannot provide tissue samples due to insufficient or absent tumor tissue, or where tissue diagnostics are not available, and validate the clinical utility of blood-based NGS as an additional method to inform clinical decision-making in ALK-positive NSCLC.
In the study, 87.4% (95% CI: 78.5-93.5) of people with advanced NSCLC who were identified by the FoundationOne Liquid biopsy assay to have ALK fusions had a confirmed response to treatment with Alecensa (overall response rate; ORR) as measured by the investigator per RECIST v1.1. This is consistent with the ORR for Alecensa observed in the pivotal phase III ALEX trial, which identified people using tissue-based testing.
When measured using an Independent Review Facility per RECIST v1.1, the confirmed ORR was numerically higher at 92.0% (95% CI: 84.1-96.7). Median progression free-survival and duration of response were not reached after a median follow-up of 12.6 months. The safety profile of Alecensa was consistent with prior clinical trials and post-marketing experience, with no new safety signals observed.
