BioPharma, Diagnostics

Foundation Medicine appoints new CEO; exec provides forecasts for precision medicine in 2019

With the approval of Loxo’s Vitrakvi, pan-cancer drugs and an emphasis on real-world data are likely to become important trends trends this year.

genomics

A next-generation sequencing firm that last year became wholly owned by Swiss drugmaker Roche has appointed a new leader.

Cambridge, Massachusetts-based Foundation Medicine said Monday that it had appointed Cindy Perettie as CEO, effective Feb. 4. Succeeding Troy Cox, Perettie was most recently senior vice president for global oncology product strategy at Roche’s oncology unit. She previously had begun working for Genentech in 2004 and continued working there through that company’s 2009 acquisition by Roche, before moving to the Sarah Cannon Research Institute as president for global development innovations.

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Foundation Medicine markets genomic sequencing products for use in oncology, including in next-generation sequencing for solid and hematological cancers and liquid biopsy. Roche, which was already a majority shareholder in the company, bought the rest of it in June for $2.4 billion.

The Roche acquisition and new executive appointment have come at a time when genomic sequencing has become a crucial component of precision medicine.

In an interview at the J.P. Morgan Healthcare Conference in San Francisco, Chief Business Officer Melanie Nallicheri did not comment on Perettie’s appointment, but discussed some of her expectations for what 2019 has in store for precision medicine.

In particular, she said the November approval of Loxo Oncology and Bayer’s Vitrakvi (larotrectinib) is a taste of things to come. “This is the second pan-cancer approval,” she said. “So the notion of really moving away from cancer as a tissue disease to cancer as a genomic disease, we’re starting to see that take hold.

Loxo has a partnership with Illumina to develop a companion diagnostic for Vitrakvi, though Nallicheri noted that Foundation Medicine works with the company as well. Eli Lilly & Co. said Monday it would acquire Loxo for $8 billion.

When there was only one such approval, namely for Merck & Co.’s Keytruda (pembrolizumab) in microsatellite instability-high and mismatch repair-deficiency cancers in 2017, it may have been possible to say that was a one-off, she said. But Vitrakvi’s approval changes that. Yet, even the Keytruda approval may be predictive. Quantitative biomarkers like MSI-H and tumor mutational burden can support approval, so that’s probably an important trend of which more will be seen.

Another area in which Nallicheri said Foundation Medicine can have a role is in providing real-world clinical data, which she said is also likely to become an important trend in 2019, particularly given the guidance from the Food and Drug Administration. A guidance released last month outlined a new framework for advancing real-world evidence to support drug and biologic development. In addition, in a breakout session at JPM Tuesday, executives from Roche emphasized the potential for historical data to serve as a synthetic control arm, pointing to the Swiss drugmaker’s $1.9 billion acquisition of Flatiron Health in February 2018. “The idea that you can replace control arms with historical data is tangible,” Roche CEO Severin Schwan said in the session. “This is not just a hypothesis – it’s real life.”

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