Lynparza (olaparib) has been approved in Japan as a first-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer that is responding, partially or completely, to their initial chemotherapy, AstraZeneca and Merck (known as MSD outside the U.S. and Canada) announced.
Similar approvals have previously been granted in the U.S., Europe, Canada, and Brazil. This approval, by the Japanese Ministry of Health, Labour and Welfare, was based on clinical data from the ongoing SOLO-1 Phase 3 trial (NCT01844986), in which Lynparza cut by 70% the risk of disease progression or death compared with a placebo.
“Advances in understanding the role of BRCA mutations and PARP inhibition have fundamentally changed how physicians can treat this aggressive type of cancer. With the approval of this new indication, patients in Japan with BRCA-mutated advanced ovarian cancer who respond to chemotherapy will have the opportunity to benefit from Lynparza in the first-line maintenance setting,” Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a press release.
SOLO-1 enrolled 391 ovarian cancer 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.
Participants were randomly selected to receive either Lynparza or a placebo twice daily, for two years or until their disease progressed. Those with a partial response to the therapy at two years could potentially continue treatment.
SOLO-1 aimed to determine whether Lynparza was better than a placebo at extending the time women 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, researchers found that 60% of women taking Lynparza were alive, without signs of cancer recurrence or progression, compared with 27% of those receiving a placebo. The findings represented a 70% reduction in the risk of death or disease progression in these patients.
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 women were still receiving Lynparza.
“This approval in Japan is a critical advance for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy are long-term remission or a cure, yet currently 70% of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to transform patient outcomes,” said Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca.
AstraZeneca and Merck are currently enrolling participants for the PAOLA-1 Phase 3 trial (NCT02477644), which is testing 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 are expected this year.