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Clinical Trials

Date: 2017-02-17

Type of information: Results

phase: 3

Announcement: results

Company: AstraZeneca (UK)

Product: Lynparza™ (olaparib)

Action mechanism:

poly ADP-ribose polymerase (PARP) inhibitor/enzyme inhibitor. Lynparza™ (olaparib) is an oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. Lynparza™ is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the U.S. and Europe. In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.

 

Disease: HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations

Therapeutic area: Cancer - Oncology

Country: Bulgaria, China, Czech Republic, France, Hungary, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Switzerland, Taiwan, Turkey, UK, USA

Trial details:

OLYMPIAD is a randomised, multi-center Phase III trial assessing the efficacy and safety of Lynparza® (300 mg twice daily) to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international study was conducted in 19 countries from across Europe, Asia, North America and South America. The primary endpoint of the trial was progression-free survival (PFS) as measured by a Blinded Independent Central Review (BICR). Secondary endpoints include overall survival (OS), time to second progression or death (PFS2), objective response rate (ORR), and effect on health-related quality of life (HRQoL).  (NCT02000622)

Latest news:

* On February 17, 2017, AstraZeneca announced positive results from its Phase III OLYMPIAD trial comparing Lynparza® (olaparib) tablets (300mg twice daily) 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). Initial findings from the OLYMPIAD study indicate that the safety profile of Lynparza® was consistent with previous studies. A full evaluation of the OLYMPIAD 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.

 

 

Is general: Yes