Lynparza 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.

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). 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.

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."