A companion for Lynparza

More precisely, on June 6, Foundation Medicine and AstraZeneca announced that they had entered into a definitive agreement to develop a novel companion diagnostic assay for Lynparza to support AstraZeneca’s global development program and enable physicians to identify patients most likely to benefit from receiving olaparib.

Lynparza is already approved in the European Union for the treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, and it has approval in the United States for the treatment of patients with germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Because the PARP inhibitor exploits tumor DNA repair pathway deficiencies to preferentially kill cancer cells, Lynparza’s mode of action means it has potential for activity in a range of tumor types with DNA repair deficiencies, potentially giving it greater therapeutic reach than the cancers noted above.

Under the terms of the agreement, Foundation Medicine will develop and make available a regulatory approved product utilizing 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 program for Lynparza, as part of a coordinated drug-diagnostic regulatory strategy.

Nina Mojas, global medicine lead for Lynparza at AstraZeneca said, “This agreement supports the broad development program for our first-in-class PARP inhibitor, Lynparza. 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.”

“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,” stated Dr. Steven J. Kafka, president and chief operating officer for Foundation Medicine. “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.”

Earlier this year, in January, Zacks Investment Research noted with regard to AstraZeneca’s Lynparza efforts that it was encouraged by the granting Breakthrough Therapy designation from the U.S. Food and Drug Administration for the drug in treating prostate cancer.

“We note that Lynparza was approved in 2014 for the maintenance treatment of women with BRCA-mutated ovarian cancer. The drug has registered sales of $58 million in the first nine months of 2015. Label expansion would boost the drug’s sales further,” wrote Zacks at the time. “AstraZeneca is evaluating the potential of Lynparza in other PARP-dependent tumors. Currently, Phase 3 studies on Lynparza are ongoing for several indications like gastric cancer and pancreatic cancer, among others, with additional studies being planned. The company is aiming to bring six new cancer medicines to the market by 2020.”