China’s National Medical Products Administration (NMPA) has approved AstraZeneca and Merck’s (known as MSD outside of the US and Canada) Lynparza (olaparib) as maintenance therapy for a type of ovarian cancer.
A PARP inhibitor, Lynparza is the first targeted treatment, which is designed to inhibit DNA damage response (DDR) in cells/tumours which harbour deficiency in homologous recombination repair (HRR), including mutations in BRCA1 and/or BRCA2.
It is indicated as the maintenance treatment for advanced epithelial ovarian, fallopian tube or primary peritoneal cancer adult patients who are in complete or partial response to the first-line platinum-based chemotherapy and bevacizumab combination.
Lynparza is also approved to treat patients whose cancer is related to homologous recombination deficiency (HRD)-positive status.
The regulatory approval was based on data obtained from the PAOLA-1 Phase III trial.
The double-blinded study was designed for evaluating the safety and efficacy of Lynparza along with standard of care bevacizumab compared to bevacizumab alone for HRD-positive advanced ovarian cancer patients.
In the trial, Lynparza and bevacizumab combination showed improvement in substantial progression-free survival (PFS) compared to bevacizumab alone in HRD-positive advanced ovarian cancer patients.
The final overall survival (OS) results showed that the combination of Lynparza and bevacizumab offered a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer.
AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The maintenance treatment of Lynparza in combination with bevacizumab has shown to both improve progression-free survival and provide a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer following response to platinum-based chemotherapy.”
The trial’s initial findings demonstrated that the combination treatment reduced the risk of disease progression or mortality by 67%.