These results were published in The New England Journal of Medicine in 2019. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. The addition of LYNPARZA to bevacizumab improved PFS to a median of 37.2 months vs.
#Hrd positive ovarian cancer trial#
The PAOLA-1 trial showed that LYNPARZA in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (HR 0.33 ). The EU approval reinforces that HRD-positive tumors represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.” Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this devastating disease. HRD status can help physicians select a personalized first-line treatment regimen for patients to substantially delay relapse in this devastating disease.”ĭr.
#Hrd positive ovarian cancer free#
Women treated with LYNPARZA in combination with bevacizumab in the PAOLA-1 Phase 3 trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.ĭave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors. The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 Phase 3 trial showing LYNPARZA in combination with bevacizumab maintenance treatment demonstrated progression-free survival (PFS) benefit versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. KENILWORTH, N.J.-( BUSINESS WIRE)-AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that LYNPARZA in combination with bevacizumab has been approved in the European Union (EU) 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 homologous recombination deficiency (HRD)-positive status defined by either a breast cancer susceptibility gene 1/2 ( BRCA1/2) mutation and/or genomic instability.
0 kommentar(er)
