Lynparza® (olaparib) phase III SOLO-2 trial shows significant progression-free survival benefit for women with ovarian cancer

Access for Canadian women remains in jeopardy despite mounting evidence of significant clinical benefits of Lynparza

MISSISSAUGA, ON, Nov. 1, 2016 /CNW/ - AstraZeneca has announced positive results from the Phase III SOLO-2 trial, designed to determine the efficacy of Lynparza^® (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer. Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo and provide additional evidence to support the potential use of Lynparza in this patient population.

Importantly, the median PFS in the Lynparza arm of SOLO-2 substantially exceeded that observed in the Phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19).¹ Initial findings demonstrate that the safety profile with Lynparza tablets was consistent with previous studies. Full results of SOLO-2 will be presented at a forthcoming medical meeting.

"These results support earlier studies that demonstrate Lynparza's significant and clinically meaningful benefits, including potentially prolonging life in this small and well-defined patient population," said Mark Findlay, Vice President, Patient Access & Established Brands, AstraZeneca Canada. "Canadian women living with BRCA-mutated relapsed ovarian cancer deserve access to this meaningful advancement in treatment."

Health Canada issued a Notice of Compliance with Condition for Lynparza capsules earlier this year based on safety and efficacy data from Study 19, for monotherapy maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. Since 2014, more than 45 countries have approved Lynparza, several of which have provided accelerated approval, including the United States.²

Recently, the pan-Canadian Oncology Drug Review (pCODR) announced its decision not to recommend Lynparza for provincial reimbursement, due to uncertainty with the medicine's clinical benefits despite its wide regulatory approval, the critical need for access to new ovarian cancer treatment options, and the fact that similar agencies in many countries around the world have enabled access to this medication.

"Given the positive results of the SOLO-2 study, and the treatment gap in Canada for women with ovarian cancer, we urge pCODR to collaborate with AstraZeneca to re-evaluate Lynparza on an urgent basis," says Findlay. "Ovarian cancer is deadly and impacts women in the prime of their lives. Extending time for these women is of critical importance. Provincial governments must act swiftly to ensure Canadian women with ovarian cancer are not left behind when it comes to accessing this innovative, targeted treatment."

About Lynparza^® (olaparib)
Lynparza is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer. Health Canada's Notice of Compliance with Conditions for Lynparza follows the announcement of the approval of Lynparza by the FDA on December 19, 2014 and in the European Union on December 18, 2014. AstraZeneca is conducting multiple Phase III studies across a variety of indications and tumour types for Lynparza.

Lynparza is a trademark of the AstraZeneca group of companies.

About SOLO-2
SOLO-2 was a Phase III, multicentre trial designed to determine the efficacy of Lynparza tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed or recurrent BRCA-mutated (BRCAm) ovarian cancer. In SOLO-2, patients with either germline or somatic BRCAm status were eligible for enrolment, although due to the lack of widespread availability of tumour BRCA testing, most patients were enrolled on blood-based germline testing. Those few patients who were enrolled based on a tumour test were also found to have a germline BRCA mutation. Patients were randomized to receive either Lynparza tablets (300mg twice daily) or placebo until disease progression.¹

The trial, conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d'Investigateurs National pour l'Etude des Cancers de l'Ovaire et du sein (GINECO), randomized 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least 2 prior lines of platinum-based chemotherapy.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our AstraZeneca Canada headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

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¹ National Institutes of Health. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. Available at: http://clinicaltrials.gov/show/NCT01874353. Last accessed October 2016.
² AstraZeneca Feedback on pERC Initial Recommendation. Lynparza (olaparib) for PSR BRCAm Ovarian Cancer, on file.

SOURCE AstraZeneca Canada Inc.

Michelle Marchione, Senior Manager, Corporate Communications, AstraZeneca Canada, Tel: [phone], Email: [email protected]