Foundation Medicine, Inc. (NASDAQ: FMI) and Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the expansion of their ongoing collaboration to incorporate a coordinated regulatory strategy for the development of a novel Premarket Approval (PMA) companion diagnostic test. This test is designed for use by physicians to identify patients most likely to respond to rucaparib, Clovis' poly (ADP-ribose) polymerase (PARP) inhibitor currently the subject of Phase 2 and Phase 3 clinical trials in patients with ovarian cancer.
This companion diagnostic is being developed in parallel with the clinical development of rucaparib to facilitate an FDA submission of the PMA for the companion diagnostic concurrent with the New Drug Application (NDA) for rucaparib. Foundation Medicine's platform, upon which the companion diagnostic will be based, is currently in use in Clovis' ongoing ARIEL2 clinical study of rucaparib in patients with ovarian cancer. The test assesses multiple cancer-related genes as well as all classes of genomic alterations, and it utilizes advanced algorithms based on Foundation Medicine's molecular information platform.
"Patient selection is a key aspect of our development and regulatory strategy for rucaparib. Ovarian cancer patients often present with a molecular signature of DNA repair deficiencies beyond germ-line BRCA that cannot be characterized by the conventional diagnostic tests available today," said Patrick J. Mahaffy, president and CEO of Clovis Oncology. "We are pleased to advance our collaboration with Foundation Medicine and utilize their unique genomic profiling platform and expertise to identify patients most likely to benefit from rucaparib."
Since 2012, Foundation Medicine has been conducting comprehensive genomic profiling to analyze tissue samples from ovarian cancer patients enrolled in rucaparib clinical trials in order to identify biomarkers associated with response. Initial findings identified the molecular signatures of likely responders, and the companies are now working together to incorporate the genomic signature into a companion diagnostic test. Under the terms of the expanded agreement, Foundation Medicine will build a dedicated laboratory to support the development and FDA-approval of the companion diagnostic test and will receive milestone payments for its successful development and registration.
"In addition to helping bring an important new therapy to patients with ovarian cancer, this collaboration marks a paradigm shift in the development of companion diagnostics. The use of Foundation Medicine's platform is an important step in the evolution of cancer care from a static, single-gene companion diagnostic approach toward a universal companion diagnostic standard," said Michael J. Pellini, M.D., president and CEO of Foundation Medicine. "This agreement complements Foundation Medicine's plans to develop an FDA-approved companion diagnostic and supports our overall strategy to work with the FDA to establish the appropriate regulatory framework for novel, comprehensive genomic profiling platforms. We are very pleased to continue our support of Clovis' highly differentiated clinical development program and maintain our efforts with the company to identify the ovarian cancer patients most likely to benefit from rucaparib."
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