Biopharmaceutical firm AstraZeneca has announced positive results from its Phase III clinical trial (OlympiAD) of Lynparza (olaparib) to treat patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations.
Lynparza is an oral poly ADP-ribose polymerase (PARP) inhibitor expected to utilise tumour DNA damage response (DDR) pathway deficiencies to potentially destroy cancer cells.
Conducted in 19 countries across Europe, Asia, North America and South America, the randomised, multi-centre Phase III study compared the efficacy and safety of the drug in tablet form to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients.
The trial's primary endpoint was progression-free survival (PFS), while the secondary outcomes include overall survival (OS), time to second progression or death (PFS2), objective response rate (ORR) and effect on health-related quality of life (HRQoL).
AstraZeneca 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."
It was found that patients administered with the drug showed a statistically significant and clinically meaningful improvement in PFS compared with those who were treated with chemotherapy.
The results from the trial also indicated that Lynparza's safety profile was consistent with previous studies.
The drug is currently being evaluated in another Phase III trial for non-metastatic breast cancer.
Lynparza tablets are also being studied in monotherapy and in combinations in a range of tumour types such as ovarian, prostate and pancreatic cancer.