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Roche to Use Foundation Medicine's Test in Phase III Anti-PD-L1 Drug Trials

NEW YORK (GenomeWeb) – Following the successful closing of its tender offer for a majority stake in Foundation Medicine, Roche today provided an update on how it intends to collaborate with the firm for its clinical drug development. Roche also provided an update on its other next-generation sequencing-based investments.

Since the transaction closed this month, Roche holds about 57 percent of Foundation Medicine's common stock. Earlier this year, the companies said they would collaborate in four areas of R&D: integrating Foundation's tumor profiling platform into Roche's clinical development, developing new diagnostics in the areas of cancer immunotherapy and circulating tumor DNA analysis, co-developing companion diagnostics, and developing in vitro diagnostic kits for Foundation's tests.

During Roche's first-quarter earnings call today, Daniel O'Day, COO of Roche Pharmaceutical, said that as an "immediate start" to its collaboration with Foundation Medicine, Roche will employ the FoundationOne assay across phase III clinical trials for its PD-L1 inhibitor, MPDL3280A, Roche's main cancer immunotherapy drug candidate.

Roche currently has seven phase III anti-PD-L1 trials that are either ongoing or about to start, five of them for non small cell lung cancer, one for triple-negative breast cancer, and one for renal cell carcinoma. Primary completion of the NSCLC trials is expected in 2017 and 2018. The firm's drug candidate is a monoclonal antibody that inhibits PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, resulting in the activation of T cells that restores their ability to detect and attack tumor cells.

In addition, Roche and Foundation Medicine will be working on RNA signatures, with the goal of developing a specific immunotherapy panel that can predict patient benefit, O'Day said.

Apart from Foundation Medicine, Roche has made a number of other recent investments in the area of next-generation sequencing and related technologies for diagnostics. For example, the company acquired non-invasive prenatal diagnostics firm Ariosa Diagnostics last December, and is seeing "very good uptake in sales of the Harmony prenatal test," Roland Diggelmann, COO of Roche Diagnostics, said during the call, adding that the recently published NEXT study "supports the use of NIPT as a first-line screening option."

Roche also recently acquired Signature Diagnostics, which he said offers both a biobank and technology to advance translational research for NGS diagnostics, and CAPP Medical, which has a technology for isolating circulating tumor DNA from blood for sequencing. These technologies, together with Roche's previous and ongoing investments in NGS instrumentation, will require further investments, he said.