Olaparib in Combination with Bevacizumab Receives FDA Priority Review for First-Line Maintenance Treatment of Advanced Ovarian Cancer

Today,AstraZeneca(AstraZeneca) and MSD announced that the United StatesFDAThe supplemental New Drug Application (sNDA) for olaparib (brand name: Lynparza), in combination with bevacizumab, has been accepted and granted Priority Review designation for first-line maintenance treatment of patients with advanced ovarian cancer who have responded completely or partially to platinum-based chemotherapy. If approved, this will mark the fourth indication for Lynparza in the treatment of ovarian cancer in the United States.

Ovarian cancer is the eighth most common cause of cancer-related deaths among women worldwide. In 2018, there were nearly 300,000 new cases and approximately 185,000 deaths. Most women are diagnosed with advanced-stage ovarian cancer, with a five-year survival rate of about 30%. For newDiagnosisIn advanced ovarian cancer, the primary goal of treatment is to delay disease progression for as long as possible and maintain the patient's quality of life, with the aim of achieving complete remission or cure.

Olaparib is the first approved PARP inhibitor and the first targeted therapy directed at defects in the DNA damage repair (DDR) pathway, such as BRCA gene mutations. As two critical DNA repair proteins in cells, PARP primarily repairs single-strand DNA damage, whereas BRCA primarily repairs double-strand DNA damage. In cancer patients harboring BRCA1 or BRCA2 mutations, the inactivation of BRCA proteins renders DNA damage repair highly dependent on PARP. If PARP activity is further inhibited, thenTumorExtensive DNA damage occurs during cell division, ultimately leading to cell death. PARP inhibitors can not only in patients with BRCA mutationsBreast CancerIt has also demonstrated significant efficacy in patients with ovarian cancer, as well as in prostate cancer patients harboring BRCA mutations.

FDAThe granting of priority review status is based on the pivotal Phase 3Clinical TrialThe results of PAOLA-1, published in The New England Journal of Medicine. This trial compared the efficacy of Lynparza combined with bevacizumab versus bevacizumab alone as first-line maintenance therapy in patients with advanced ovarian cancer.

Investigator-assessed results demonstrated that Lynparza in combination with bevacizumab reduced the risk of disease progression or death by 41% (HR=0.59, p<0.0001) and extended median progression-free survival (PFS) from 16.6 months to 22.1 months. Two years after trial initiation, 46% of patients receiving Lynparza plus bevacizumab remained free of disease progression, compared with 28% in the bevacizumab monotherapy group.

United StatesFDAA response to this application is expected in the second quarter of this year. (BioValleyBioon.com）