German pharmaceutical firm Bayer and NGS-based solutions provider ArcherDX, have collaborated for the development and commercialisation of a NGS-based companion diagnostic (CDx) for Vitrakvi (larotrectinib).
The collaboration is aimed at widening patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions.
The main objective of the collaboration is also to help improve identification of appropriate treatment options for patients with TRK fusion cancer, which affects both children and adults.
Bayer’s oncology strategic business unit head Robert LaCaze said: “In order to help more patients to benefit from Vitrakvi, broader access to high quality testing via next-generation sequencing is of key importance.
“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.”
Vitrakvi is an advanced TRK inhibitor intended for TRK fusion cancer across solid tumors
Vitrakvi is an advanced TRK inhibitor for TRK fusion cancer across solid tumors and is indicated for the treatment of adult and pediatric patients with solid tumors.
It is approved in several markets, including the US, EU, Canada and Brazil.
NGS-based CDx tests are aimed at unlocking molecular information from the tumor genome of patients to help physicians in treatment decisions for cancer therapies.
ArcherDX is developing an in vitro diagnostic (IVD), a NGS-based therapy selection product that leverages Anchored Multiplex PCR (AMP) technology to measure clinically relevant genomic mutations for tumor profiling and CDx from both tissue and blood.
Under the collaboration, ArcherDX and Bayer will develop a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3 for Vitrakvi and intend to seek regulatory approvals the European Union (EU), the US and Japan.
ArcherDX chief executive officer and co-founder Jason Myers said: “Barriers currently exist that inhibit the broad adoption of genomic testing to inform treatment decisions. 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.
“For these patients, our technology provides RNA-based profiling for the detection of actionable fusions across known and novel NTRK fusion partners. We are pleased to collaborate with Bayer to address their medical need and accelerate access to therapy.”
