A late-stage study of AstraZeneca's PARP inhibitor Lynparza in patients with HER2-negative metastatic breast cancer who also carry BRCA1 or BRCA2 mutations has its primary target in boosting progression-free survival (PFS).
In the international Phase III OLYMPIAD trial, 302 patients were randomised to receive either Lynparza (olaparib) or a physician's choice of chemotherapy. According to top-line data, AstraZeneca's drug showed a significant and clinically-meaningful improvement in PFS versus chemotherapy, meeting the study's main endpoint.
"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," said Sean Bohen, AZ' executive vice president, Global Medicines Development and chief medical officer. "This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways."
A full evaluation of the OLYMPIAD data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting, AZ said, also noting that it will be working with regulatory authorities to make Lynparza available to patients with this type of breast cancer.
Lynparza is currently approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of 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. It is also approved in the US as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
The drug is currently being assessed in a separate non-metastatic breast cancer Phase III study called OLYMPIA, which is still recruiting patients internationally.
Elsewhere, AZ also announced results of Study 1108, the data underpinning the regulatory submission for durvalumab in locally advanced or metastatic urothelial carcinoma, presented at ASCO Genitourinary Cancers Symposium over the weekend.
Updated results from the Phase I/II trial showed an objective response rate of 20.4 percent in all evaluable patients and 31.1 percent in patients whose tumours express PD-L1. At the time of data cut-off, median overall survival was 14.1 months.
"The clinical efficacy of durvalumab in patients with advanced UC is particularly encouraging," noted Professor Thomas Powles, director of Barts Cancer Centre. "For the past three decades we've seen limited progress in therapy for bladder cancer patients, and there remains significant unmet need for new treatment options."
Meanwhile, AZ also announced that it has entered into an agreement with TerSera Therapeutics for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada.
Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders, generating annual sales of $69 million in those territories (and $816 million globally).
TerSera will pay AstraZeneca $250 million upon completion of the deal, as well as sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of product sales.
"This agreement allows us to retain a significant share of the value of Zoladex in the US and Canada, while concentrating our resources on our innovative New Oncology medicines," said Mark Mallon, executive vice president, Global Product & Portfolio Strategy at AZ, commenting on the deal. "It also ensures patients have continued access to Zoladex, with TerSera's dedicated focus helping to expand the potential of this important medicine."
The transaction is expected to complete in the first quarter of 2017, subject to customary closing conditions.