AstraZeneca Phase III breast cancer trial met primary endpoint

AstraZeneca announced positive results from its Phase III trial comparing Lynparza (olaparib) tablets to physician’s choice of a standard of care chemotherapy, in the treatment of patients with HER2-negative metastatic breast cancer, harbouring germline BRCA1 or BRCA2 mutations.

Patients treated with Lynparza showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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."

Safety and Efficacy

Initial findings from the study indicate that the safety profile of Lynparza was consistent with previous studies.  

A full evaluation of the data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting. AstraZeneca will be working with regulatory authorities to make Lynparza available to patients with this type of breast cancer.