The maintenance treatment using the drug regimen reduced the risk of disease progression or death by 67%, and improving PFS2 to a median of 50.3 months, compared to 35.3 with bevacizumab alone
EC approves Lynparza plus bevacizumab to treat ovarian cancer. (Credit: Sébastien Bertrand/Wikipedia.)
The European Commission (EC) has approved AstraZeneca and MSD’s Lynparza (olaparib) in combination with bevacizumab as the first-line maintenance treatment for homologous recombination deficient (HRD)-positive advanced ovarian cancer.
The EC approval indicated Lynparza plus bevacizumab for the maintenance treatment of adults with HRD positive advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, responding to platinum-based chemotherapy.
Lynparza is a PARP inhibitor, jointly developed by AstraZeneca and MSD under an oncology collaboration, while bevacizumab is a cancer treatment co-developed and marketed under brand name Avastin, by Novartis and Roche.
AstraZeneca is expected to receive a regulatory milestone payment of $25m from MSD following the regulatory approval for Lynparza in the EU, under the terms of their partnership agreement.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumours.
“Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase III trial lived progression free for a median of more than three years, showing that HRD testing should be an essential component of clinical diagnosis.
“HRD status can help physicians select a personalised 1st-line treatment regimen for patients to substantially delay relapse in this devastating disease.”
Phase 3 PAOLA-1 trial supported EC approval for Lynparza plus bevacizumab
The European regulatory approval was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1, a double-blinded Phase 3 trial, which evaluated the efficacy and safety of Lynparza in combination with bevacizumab, compared with bevacizumab alone.
In the study, treatment using Lynparza plus bevacizumab has met the primary endpoint of significant improvement in progression-free survival (PFS) in patients with HRD-positive advanced ovarian cancer, compared to bevacizumab alone.
Also, the EC approval follows the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CMPH) recommendation, granted in September 2020.
The maintenance treatment using the drug regimen reduced the risk of disease progression or death by 67%, and improving PFS2 to a median of 50.3 months, compared to 35.3 with bevacizumab alone.
Lynparza plus bevacizumab was approved in the US and other countries as a first-line maintenance treatment for HRD-positive advanced ovarian cancer patients and is currently being reviewed in other countries worldwide.
Phase 3 PAOLA-1 trial principal investigator Isabelle Ray-Coquard said: “For women with advanced ovarian cancer, the goal of 1st-line treatment is to delay disease progression for as long as possible with the intent of achieving long-term remission. Unfortunately, once a patient’s cancer recurs, it historically has been incurable.
“Lynparza together with bevacizumab has demonstrated an impressive median progression-free survival benefit of more than three years and is poised to become the standard of care for eligible patients with HRD-positive tumours in the EU.”