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AstraZeneca's Lynparza meets primary endpoint in breast cancer study

PBR Staff Writer Published 20 February 2017

A phase 3 study of AstraZeneca’s Lynparza (olaparib) met primary endpoint in a phase III trial in BRCA-mutated metastatic breast cancer.

The study, dubbed Olympiad, was carried out in HER2-negative metastatic breast cancer patients having germline BRCA1 or BRCA2 mutations with the drug candidate trialed against physician’s choice of a standard of care chemotherapy.

Patients subjected to Lynparza had both statistically and clinically improved progression-free survival (PFS), the primary endpoint, in comparison with those who were administered chemotherapy either through capecitabine, vinorelbine or eribulin.

AstraZeneca executive vice president, global medicines development and chief medical officer Sean Bohen said: “These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive Phase III data for a PARP inhibitor beyond ovarian cancer.

“This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways.”

Preliminary findings from the phase 3 study demonstrated that Lynparza’s safety profile was on par with previous studies.

Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor intended to exploit pathway deficiencies in tumour DNA damage response (DDR) to kill cancer cells preferentially.

It had earlier secured approval in the EU as monotherapy for the maintenance treatment of certain types of cancer, including adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

In the US, the drug is approved as monotherapy in ovarian cancer patients with certain conditions.


Image: Laboratory testing at AstraZeneca. Photo: courtesy of AstraZeneca.