#HRD POSITIVE TRIAL#

WASHINGTON, D.C., The United States вЂ“ Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

#HRD POSITIVE TRIAL#

FDA approval was granted due to the biomarker subgroup analysis conducted in the Phase 3 PAOLA-1 trial in which Lynparza with bevacizumab maintenance treatment was shown to reduce the risk of disease progression or death by 67%, and the addition of Lynparza to bevacizumab improved progression-free survival (PFS).To be selected for treatment with Lynparza, patients must take an FDA-approved companion diagnostic test.Lynparza (olaparib) in combination with bevacizumab (branded as Avastin) was approved by the US Food and Drug Administration (FDA) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.This combination treatment has been approved in the US in 2020 for patients with this form of ovarian cancer, and is under review in multiple other countries. This recommendation and the results from the PAOLA-1 trial underscore the importance of HRD testing at diagnosis to determine the best course of treatment for women with advanced ovarian cancer.вЂќ Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at MSD Research Laboratories, said: вЂњHRD is an important biomarker of advanced ovarian cancer that can inform how physicians in the EU treat this aggressive type of cancer. The results also showed statistically significant improvement in the time to second disease progression, with a median improvement of 50.3 months versus 35.3 months with bevacizumab. This recommendation is a vital step toward addressing a significant unmet need and could bring a new treatment option that delays relapse in this devastating disease.вЂќДЇurther results from the trial were also presented at the European Society for Medical Oncology (ESMO) Virtual Congress and showed that the combination treatment demonstrated a significant improvement in the time to second disease progression compared to bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Lynparza together with bevacizumab has demonstrated a median progression-free survival benefit of more than three years, offering new hope for women in this setting. JosГ© Baselga, Executive Vice President of Oncology R&D at AstraZeneca said: вЂњHalf of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours. It also improved progression-free survival by a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. The PAOLA-1 trial showed that the combination of Lynparza with bevacizumab as a maintenance treatment reduced the risk of disease progression or death by 67%. This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine.ДЇirst-line treatments for patients with ovarian cancer are designed to delay the disease's progression for as long as possible to help achieve long-term remission. AstraZeneca and MSDвЂ™s Lynparza (olaparib) has been recommended for marketing authorisation across the European Union for the first-line maintenance treatment with bevacizumab for patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.