Bayer has teamed up with Foundation Medicine to develop genetic diagnostic tests for several of its cancer therapies—starting with the tissue-agnostic Vitrakvi in solid tumors with TRK fusion mutations.
Acquired from Loxo Oncology, Bayer’s Vitrakvi (larotrectinib) was the first targeted cancer drug to be developed and approved specifically for a pan-cancer indication, based not on a tumor’s organ site but on its genetic makeup.
So it seems like an easy match for Foundation Medicine, whose FoundationOne CDx test was the first broad companion diagnostic approved by the FDA to work across all solid tumors. The kit analyzes guideline-recommended genes—as well as the immunotherapy biomarkers of microsatellite instability, tumor mutational burden and PD-L1—to help guide at least 17 targeted therapies.
But an interesting dynamic of the collaboration lies with Foundation’s Big Pharma benefactor, Roche, which is developing a potential rival to Bayer’s drug. The Swiss drugmaker’s entrectinib was recently granted FDA priority review in NTRK fusion-positive cancers regardless of organ site as well as in non-small cell lung cancer with ROS1 mutations.
However, following its $2.4 billion buyout last year, Roche granted Foundation the autonomy to continue its work with other biopharma companies, including companion diagnostic partnerships with Merck, Pfizer and others.
Vitrakvi, meanwhile, was granted accelerated approval in November 2018 and is currently under review in other global markets, according to Bayer. One of the main issues the company faces is the identification of eligible patients, because the genetic testing required for its use isn’t yet considered routine—which could be changed by its inclusion in a broad diagnostic like the FoundationOne test.
The financial details of Bayer’s collaboration with Foundation Medicine have not been disclosed. Analysts have projected a range of peak sales for Vitrakvi over the next decade from $700 million to at least $1 billion.