Lynparza (olaparib) has been approved in the European Union for the first-line maintenance treatment with bevacizumab of patients with homologous recombination deficient-positive advanced ovarian cancer.
Lynparza is sponsored by AstraZeneca and MSD.
The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 phase III trial, which showed that Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.
The PAOLA-1 Phase III trial showed that Lynparza, in combination with bevacizumab maintenance treatment, reduced the risk of disease progression or death by 67% (based on a hazard ratio of 0.33; 95% confidence interval 0.25-0.45). The addition of Lynparza improved PFS to a median of 37.2 months versus 17.7 with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. The data from the PAOLA-1 trial was published in The New England Journal of Medicine in 2019.
Further results recently presented at the European Society for Medical Oncology Virtual Congress 2020 showed a statistically significant improvement in the key secondary endpoint of the time to second disease progression. Lynparza with bevacizumab provided benefit beyond first disease progression, improving PFS2 to a median of 50.3 months versus 35.3 with bevacizumab alone.
The full EU indication is for Lynparza in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with HRD positive status defined by either a breast cancer susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic instability.
Lynparza in combination with bevacizumab is approved in the U.S. and other countries as first-line maintenance treatment for HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries.
