Results of first prospective trial using blood-based next-generation sequencing to identify candidates for treatment

Efficacy of Alecensa^® (alectinib) in people identified to have ALK-positive non-small cell lung cancer using liquid biopsy is consistent with efficacy in those identified by tissue analysis in the pivotal Phase III ALEX study.

Roche have announced positive results from a single-arm cohort of the Phase II/III Blood First Assay Screening Trial (BFAST), using only blood-based next generation sequencing (NGS) to detect specific fusions with the aim of selecting treatment for people with advanced non-small cell lung cancer (NSCLC), without the need for tissue biopsy. Results from the anaplastic lymphoma kinase (ALK) cohort was presented at the European Society for Medical Oncology (ESMO) 2019 Congress on Monday 30 September 2019.

“Obtaining tumour 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,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “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 is pleased to partner with Roche on this study, a first-of-its-kind, pivotal trial that directly demonstrates the clinical utility of using our comprehensive blood-based assay, FoundationOne Liquid, to detect specific fusions and match NSCLC patients with first-line treatment,” said Brian Alexander, MD, chief medical officer of Foundation Medicine. “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. 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 comprehensive liquid biopsy test, which detects the four main classes of genomic alterations, microsatellite instability (MSI) and select fusions including ALK in circulating tumour DNA (ctDNA) from a blood draw. These data demonstrate that the FoundationOne Liquid assay can help to test and identify a broader population of people with advanced NSCLC who may benefit from Alecensa® (alectinib), for whom current diagnostic tests are not suitable, such as for those who cannot provide tissue samples due to insufficient or absent tumour 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% 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 Response Evaluation Criteria in Solid Tumours (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%. Median progression free-survival (PFS) and duration of response (DoR) 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.

About the BFAST Study
BFAST (Blood First Assay Screening Trial; NCT03178552) is a Phase II/III global, multi-centre, open label, multi-cohort study evaluating the safety and efficacy of targeted therapies or immunotherapies as single agents or in combination in people with unresectable, advanced or metastatic NSCLC determined to harbour oncogenic somatic mutations or be tumour mutational burden (TMB) positive as identified by blood-based NGS ctDNA assays. The Alecensa ALK-positive cohort is the first to readout, with other cohorts due to follow. The primary endpoint for the Alecensa ALK-positive cohort of the BFAST study is confirmed investigator (INV)-assessed ORR. Secondary endpoints include: independent review facility (IRF)-assessed ORR, DoR (INV and IRF), PFS (INV and IRF), overall survival (OS) and safety.

About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history. It is almost always found in people with a specific type of NSCLC called adenocarcinoma. Alecensa is now approved in 83 countries as an initial (first-line) treatment for ALK-positive, metastatic NSCLC, including in the US, Europe, Japan and China.

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