Women in the European Union with BRCA-mutated advanced ovarian cancer can now receive Lynparza (olaparib) as a first-line maintenance treatment, AstraZeneca and Merck (known as MSD outside the U.S. and Canada) announced.
The European Commission’s decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) issued last May. It will make Lynparza available for women who are responding, partially or completely, to their initial platinum-based chemotherapy.
The treatment had already been approved in the U.S. for a similar indication.
“The goals of front-line therapy have always been long-term remission and even cure, yet currently 70% of patients relapse within three years of initial treatment,” Dave Fredrickson, executive vice president of oncology business at AstraZeneca, said in a press release. “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation.”
Both U.S. and European approvals were based on clinical data from the ongoing SOLO-1 Phase 3 trial (NCT01844986), where Lynparza cut by 70% the risk of disease progression or death compared to a placebo.
SOLO-1 enrolled 391 patients with high-grade serous or endometrioid ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer and a BRCA mutation who were responding to their first-line platinum-based chemotherapy.
It aimed to determine whether Lynparza was better than a placebo at extending the time patients lived without their disease worsening. Overall survival, changes in quality of life, and safety were examined as secondary measures.
After a median follow-up of 41 months, 61% of patients on Lynparza remained alive and progression-free, compared to 27% of those receiving placebo. In other words, the risk of death or disease worsening was cut by 70% with Lynparza.
“The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes,” Fredrickson said.
The treatment’s safety profile in SOLO-1 was similar to that seen in prior Lynparza clinical trials, with the most common adverse events being nausea, fatigue, vomiting, anemia, and diarrhea. At the time of the analysis, 88% of patients were still receiving Lynparza.
“Merck and AstraZeneca are committed to improving outcomes for people with cancer and we will work to bring this new option to women in the EU, many of whom have historically poor outcomes, as quickly as possible,” said Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at MSD Research Laboratories.
The companies are also studying a combination of Lynparza and Avastin (bevacizumab) as maintenance therapy for patients with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Top-line results of the PAOLA-1 Phase 3 trial (NCT02477644) are expected this year.