Thursday, May 30, 2019
Bayer AG and Foundation Medicine, Inc. today announced a global collaboration for the development and commercialization of NGS-based companion diagnostics. This agreement allows for collaboration across multiple oncology drug candidates and approved therapies developed by Bayer and covers Foundation Medicine's full portfolio of tests, including FoundationOne®CDx. The first project will be to develop a companion diagnostic for Vitrakvi® (larotrectinib), the first and only TRK inhibitor approved in the U.S. for patients with TRK fusion cancer across all solid tumors.
In the United States, Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.1 This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
NGS based companion diagnostic tests aim to unlock molecular information from each patient's tumor genome to guide treatment decisions for cancer therapies. FoundationOne®CDx is the first FDA-approved broad companion diagnostic for all solid tumors2.
"We are excited to collaborate with Foundation Medicine to develop new companion diagnostics and provide tools to move to a more personalized treatment approach," said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "The development of a companion diagnostic for Vitrakvi, and our broader collaboration with Foundation Medicine, is an important step forward toward expanding access to testing and identifying the right treatment options for patients with cancer."
"Foundation Medicine is proud to collaborate with Bayer to develop multiple companion diagnostics including a companion diagnostic for Vitrakvi," stated Cindy Perettie, Foundation Medicine's Chief Executive Officer. "It is imperative that patients receive broad comprehensive genomic profiling at initial diagnosis of late stage cancer to determine if they are eligible for these medicines."
Financial terms of the agreement were not disclosed.