Pharma giant Bayer today tapped genomic analysis company ArcherDX to develop and commercialize a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi (larotrectinib). Terms of the deal were not disclosed.
Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors with the NTRK gene fusions without a known acquired resistance mutation; are either metastatic or where surgical resection will likely result in severe morbidity; and have no alternative treatments or whose disease has progressed following treatment. Bayer previously received accelerate approval for the drug based on overall response rate the duration of response. The company said continued approval for this indication may be based on further verification of clinical benefit via confirmatory trials.
The primary objective of the collaboration is to broaden patient access to genomic testing inclusive of NTRK1, NTRK2, and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options.
“In order to help more patients to benefit from Vitrakvi, broader access to high quality testing via next-generation sequencing is of key importance,” said Robert LaCaze, member of the executive committee of Bayer’s Pharmaceuticals Division and head of the Oncology Strategic Business Unit at Bayer in a press release. “The collaboration with ArcherDX perfectly complements Bayer’s CDx strategy and fits our ambition to provide the right treatment to the right patients with cancer.”
Boulder, CO-based ArcherDX is developing and pursuing regulatory clearances for a comprehensive NGS-based therapy selection product that leverages the company’s Anchored Multiplex PCR (AMP) technology to measure clinically relevant genomic mutations for tumor profiling and CDx from both tissue and blood. For its work on Vitrakvi the two companies will develop a kit-based CDx to detect NTRK gene fusions. Once developed, they will seek regulatory approval for the test in the EU, U.S., and Japan.
“Barriers currently exist that inhibit the broad adoption of genomic testing to inform treatment decisions, said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. “A kit-based CDx that is tumor agnostic and detects all NTRK gene fusions will enable high-quality genomic testing to be deployed in regional and community settings, where 85 percent of cancer patients receive care.6 For these patients, our technology provides RNA-based profiling for the detection of actionable fusions across known and novel NTRK fusion partners.”