AstraZeneca announced Friday that a Phase III study of Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations met its primary endpoint. The company said that it will work with regulatory authorities to make the PARP inhibitor available to patients with this type of breast cancer.
The OLYMPIAD trial randomised 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations to receive Lynparza or physician's choice of chemotherapy. Results indicated that patients treated with Lynparza showed a significant and clinically-meaningful improvement in progression-free survival compared with those who received chemotherapy, hitting the study's main goal.
AstraZeneca noted that secondary endpoints of the trial include overall survival, time to second progression or death, objective response rate and effect on health-related quality of life. The company added that a full evaluation of the data is ongoing and the results will be submitted for presentation at an upcoming medical meeting.
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Sean Bohen, chief medical officer at AstraZeneca, remarked "these results are positive news for patients with BRCA-mutated metastatic breast cancer...and are the first positive Phase III data for a PARP inhibitor beyond ovarian cancer." Lynparza gained approval in 2014 in Europe and the US for the treatment of patients with advanced BRCA-mutated ovarian cancer.
Last year, Lynparza generated sales of $218 million, with analysts at Berenberg predicting that the drug's annual revenue will go on to exceed $1 billion. "As a reminder the AstraZeneca turnaround story largely hinges on what happens to its oncology portfolio and progress with Lynparza is an important element of that turnaround," added Berenberg analyst Alistair Campbell.
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