Bayer, Foundation Medicine to Develop NGS-Based Pan-Cancer CDx

Bayer, Foundation Medicine to Develop NGS-Based Pan-Cancer CDx

Bayer AG and Foundation Medicine announced a global collaboration for the development and commercialization of NGS-based companion diagnostics, that will cut across multiple oncology drug candidates and approved therapies developed by Bayer. The deal covers Foundation Medicine’s full portfolio of tests, including its flagship offering FoundationOne CDx. Financial terms of the agreement were not disclosed.

The first project under this broad collaboration focus on the development of a companion diagnostic for larotrectinib (brand name Viktravi), the first and only TRK inhibitor approved November 2018 in the U.S. for patients with TRK fusion cancer across all solid tumors.

“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.”

In the U.S., 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.

NGS-based companion diagnostics hold the promise of unlocking specific information from each patient’s tumor genome to guide treatment decisions for cancer therapies based on the cancer’s molecular profile not its tissue of origin. FoundationOne CDx gained FDA approval in late 2017 as a pan-cancer companion diagnostic is the first FDA-approved broad companion diagnostic for all solid tumors.

“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 CEO. “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.”