NEW YORK (GenomeWeb) – Foundation Medicine and AstraZeneca announced today that they will develop a novel companion diagnostic assay for AstraZeneca's Lynparza (olaparib), an oral prescription medicine for women with BRCA-mutated advanced ovarian cancer who have received three or more prior chemotherapy medicines.
Under the terms of the agreement, Foundation Medicine will develop and make available an assay that will detect multiple classes of genomic alterations across a range of genes involved in homologous recombination repair. The assay is based on a scientifically selected panel of genes involved in driving the HRR process, and will be developed alongside the clinical program for Lynparza as part of a coordinated drug-diagnostic regulatory strategy.
The companion diagnostic will enable physicians to identify those patients most likely to benefit from AstraZeneca’s poly ADP-ribose polymerase inhibitor, which exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives Lynparza the potential for activity in a range of tumor types with DNA repair deficiencies.
Lynparza is approved in the US for the treatment of patients with germline BRCA-mutated advanced ovarian cancer and in the European Union for patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
"This agreement supports the broad development program for our first-in-class PARP inhibitor, Lynparza," said Nina Mojas, global medicine lead for Lynparza at AstraZeneca. "Utilizing Foundation Medicine’s leading capabilities in molecular information will help our work to assess the potential of the medicine to address unmet patient need across a number of cancers driven by DNA repair deficiencies, including and – significantly – beyond the BRCA mutations.”
In December 2014, the US Food and Drug Administration approved AstraZeneca's Lynparza as the first PARP inhibitor.
Alongside the drug, the agency approved Myriad Genetics' BRACAnalysis test as a companion diagnostic to identify germline BRCA mutations in ovarian cancer patients considering treatment with Lynparza.
Though before deciding on the BRACAnalysis CDx, AstraZeneca was initially thinking about using an HRD test to identify best responders to Lynparza, but this didn't pan out.
"The work we’ve undertaken with AstraZeneca underscores the importance and potential of utilizing our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines," said Steven Kafka, president and COO of Foundation Medicine.