AstraZeneca has entered into a definitive agreement with Foundation Medicine, Inc. (Foundation Medicine) to develop a novel companion diagnostic assay for Lynparza (olaparib) to support its global development programme.
The companion diagnostic will enable physicians to identify those patients most likely to benefit from AstraZeneca’s first-in-class poly ADP-ribose polymerase (PARP) inhibitor.
Lynparza is an innovative, oral PARP inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives Lynparza the potential for activity in a range of tumour types with DNA repair deficiencies. It is approved in the US for the treatment of patients with germline BRCA-mutated advanced ovarian cancer and in the EU for patients with platinum-sensitive relapsed BRCA-mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
Nina Mojas, Global Medicine Lead for Lynparza at AstraZeneca said: “This agreement supports the broad development programme for our first-in-class PARP inhibitor, Lynparza. Utilising 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.”
Under the terms of the agreement, Foundation Medicine will develop and make available a regulatory approved product utilising the Quality Systems Regulations (QSR) compliant version of its FoundationOne comprehensive genomic profiling platform. This assay will detect multiple classes of genomic alterations across a range of genes involved in Homologous Recombination Repair (HRR). The assay, based on a scientifically selected panel of genes known to be involved in driving the HRR process, will be developed alongside the clinical programme for Lynparza, as part of a coordinated drug-diagnostic regulatory strategy.
Steven J. Kafka, Ph.D., President and chief operating officer for Foundation Medicine said: “Following our new master collaboration agreement with AstraZeneca, we are pleased to launch this first strategic initiative to support and advance the development of Lynparza in a number of cancers. The work we’ve undertaken with AstraZeneca underscores the importance and potential of utilising our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines.”
Lynparza is the first approved medicine in a comprehensive pipeline of compounds AstraZeneca is developing targeted at the DNA Damage Repair (DDR) system. DDR is a term describing the network of cellular pathways that minimise the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially kill cancer cells, while minimising the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.