AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the European Medicines Agency (EMA) has approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status.
Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca, said: “With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile.”
Roy Baynes, senior vice president and head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women.”
The EU approval was based on two randomised trials, SOLO-2 and Study 19, which showed that Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.
In SOLO-2, the investigator-assessed analysis of PFS was supported with a blinded, independent, central radiological review of PFS, which showed a two-year difference in median PFS between Lynparza and placebo (HR 0.25 [95% CI, 0.18-0.35], p<0.0001; median 30.2 months vs 5.5 months). Overall survival (OS) data from SOLO-2 is currently immature.
In the final analysis of Study 19, with greater than five years of follow-up, the significant improvement in PFS translated into improvements in other key efficacy endpoints, regardless of BRCA status (Table 2). Additionally, the analysis showed 13% of patients treated with Lynparza remained progression-free and on therapy for five years or more years.
Filed Under: Drug Discovery