Loxo and Ventana set sights on CDx

The companies will collaborate to develop and commercialize a pan-TRK IHC test for larotrectinib

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STAMFORD, Conn.—Biopharmaceutical company Loxo Oncology Inc., which is focusing its efforts on developing selective medicines to treat genetically defined cancers, has struck up a collaboration agreement with Ventana Medical Systems Inc., a member of the Roche Group, for the development and commercialization of a pan-TRK immunohistochemistry (IHC) test. The companies will develop this test as a companion diagnostic to help pinpoint patients with different cancers that might benefit from treatment with LOXO-101 (larotrectinib).
“We are excited to partner with Roche, the global leader in developing and commercializing IHC assays for cancer diagnostics. Our initial technology assessment suggests that an IHC pan-TRK assay is feasible, which is exciting since Roche has thousands of Ventana BenchMark instruments installed worldwide,” Dr. Josh Bilenker, CEO of Loxo Oncology, commented in a press release on the deal. “IHC remains a mainstay of the cancer pathology workup, due in part to its speed, limited tissue requirements, low cost and established reimbursement paradigms. Diagnostics are a crucial part of our commercial strategy, and we believe IHC will be an important tool, alongside next-generation sequencing, that pathologists can employ in screening for patients who may benefit from larotrectinib.”
Under the terms of the agreement, Loxo and Roche will use an investigational assay piloted by Loxo Oncology, which will be further developed by Roche via its OptiView DAB detection technology. The companies will work to optimize and validate the assay, and intend to globally commercialize an analytical assay before developing a Class III assay for premarket approval from the U.S. Food and Drug Administration (FDA). Though no financial details were disclosed, the agreement stipulates that Roche will be responsible for developing, obtaining and maintaining regulatory approvals for the companion diagnostic test in the United States, specific countries in the European Union and other countries that recognize the CE/in-vitro diagnostic registration process.
Larotrectinib is a potent, oral, selective investigational new drug being developed to treat cancers with abnormalities involving the tropomyosin receptor kinases (TRKs). Recent research seems to imply that the NTRK genes that encode for TRKs can become fused to other genes, which leads to growth signals that can result in cancer. An ongoing Phase 1 trial has seen larotrectinib show promising preliminary efficacy, and the drug candidate has received Breakthrough Therapy Designation and Rare Pediatric Disease Designation from the FDA.
Loxo Oncology presented proof-of-concept clinical data for larotrectinib for all patients with TRK fusion primary central nervous system cancers at the 2017 American Association for Cancer Research meeting in a poster presentation titled “Potential role of larotrectinib (LOXO-101), a selective pan-TRK inhibitor, in NTRK fusion-positive recurrent glioblastoma.” The studied cases included three glioblastoma patients, one of whom was treated under an expanded access protocol and two who were treated in the company’s ongoing Phase 2 NAVIGATE trial. Larotrectinib demonstrated preliminary evidence of antitumor activity in all described cases, all of which had progressed following previous treatment.
The same week, the company also announced that oral presentations on larotrectinib had been accepted for the American Society of Clinical Oncology meeting being held in June. Loxo Oncology will share interim clinical data across the RECIST-evaluable TRK fusion clinical trial database from all three of its clinical trials currently underway in a presentation titled, “The efficacy of larotrectinib (LOXO-101), a selective tropomyosin receptor kinase (TRK) inhibitor, in adult and pediatric TRK fusion cancers.” At the same meeting, the company will also debut interim pediatric Phase 1 clinical trial data, which is part of the previously mentioned data, in the separate oral presentation “A pediatric phase 1 study of larotrectinib, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family.”

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