Olaparib + bevacizumab to treat advanced ovarian cancer

June 10, 2020 0 By FM

AstraZeneca and MSD Inc announced that olaparib (Lynparza) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with an advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-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. Patients will be selected for therapy based on an US FDA-approved companion diagnostic test.

The approval by the US FDA was based on a biomarker subgroup analysis of phase III PAOLA-1 trial which showed that olaparib in combination with bevacizumab maintenance treatment reduced the risk of disease progression or death by 67% (equal to a hazard ratio of 0.33). 

The addition of olaparib improved progression-free survival (PFS) to a median of 37.2 months versus 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer. 

PAOLA-1 is a double-blind phase III trial testing the efficacy and safety of olaparib in combination with bevacizumab vs. bevacizumab alone, as a 1st-line maintenance treatment for newly diagnosed advanced FIGO Stage III-IV high-grade serous or endometroid ovarian, fallopian tube, or peritoneal cancer patients who had a complete or partial response to 1st-line treatment with platinum-based chemotherapy and bevacizumab. AstraZeneca and MSD announced in August 2019 that the trial met its primary endpoint of PFS.