AstraZeneca and Foundation Medicine recently announced a collaboration aimed at developing a companion diagnostic for cancer therapeutic Lynparza, AZ’s first-in-class poly ADP-ribose polymerase (PARP) inhibitor that exploits the DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells.
Lynparza is currently approved by the FDA for 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.
Under the terms of the agreement, Foundation Medicine will leverage its Quality Systems Reporting (QSR)-compliant FoundationOne genomic profiling platform to detect multiple classes of genomic alterations involved in homologous recombination repair (HRR). The assay will identify and create a panel of genes known to be involved in driving HRR and will be developed in conjunction with the clinical development program for Lynparza, as part of a coordinated drug-diagnostic regulatory approval strategy.
“This agreement supports the broad development program for our first-in-class PARP inhibitor, Lynparza,” said Nina Mojas, AstraZeneca’s global medicine lead for Lynparza, in a prepared statement. “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.”
The Lynparza agreement comes on the heels of the two companies entering a master companion diagnostic agreement announced in early May for Foundation Medicine to develop a range of companion diagnostic assays across a broad cross section of AZ’s oncology pipeline. The developed diagnostics will be designed to help predict those patients likely to respond to specific therapy based on a cancer’s mutational profile. The Lynparza CDx deal is the first initiative under the broader agreement.
In addition to its existing approvals, AZ is actively pursuing approval Lynparza for other cancers driven by BRCA1 and BRCA2 mutations. For example, in January, the company received Breakthrough Therapy designation from the FDA for the treatment of BRCA1/2 or ATM mutated metastatic castration-resistant prostate cancer.
With the deepening of its relationship with AZ, Foundation Medicine is further strengthening its market position as a partner to oncology companies for the development of companion diagnostics. In 2015, the company inked similar agreements with, Roche, H3 Biomedicine, and Mirati Therapeutics.