AstraZeneca and Merck Sharp & Dohme (MSD) have secured the US Food and Drug Administration (FDA) approval for Lynparza (olaparib) in combination with bevacizumab to treat a type of ovarian cancer.
The regimen has been indicated for treating advanced epithelial ovarian, fallopian tube or primary peritoneal cancer adult patients, who are responding to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status.
The HRD positive status of the patients is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability. An FDA-approved companion diagnostic test will be deployed to select patients for therapy.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease.
“These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”
The FDA approval for Lynparza plus bevacizumab was based on analysis of Phase 3 PAOLA-1 clinical trial
Lynparza is an advanced PARP inhibitor and the targeted treatment to block DNA damage response (DDR) in cells or tumours with a deficiency in homologous recombination repair, including mutations in BRCA1 or BRCA2.
MSD Research Laboratories chief medical officer, senior vice president and global clinical development head Roy Baynes said: “Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer.
“Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a 1st-line maintenance treatment.”
The FDA approval was based on a biomarker subgroup analysis of Phase 3 PAOLA-1 trial which demonstrated that Lynparza plus bevacizumab would reduce the risk of disease progression or death.
In addition, the clinical trial showed that the addition of Lynparza would improve progression-free survival (PFS) compared to bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
Lynparza is currently being reviewed in the EU, Japan and other countries based on results from the PAOLA-1 clinical trial. The drug is being tested as a monotherapy to treat patients with germline BRCA-mutated high-risk HER2-negative primary breast cancer in the Phase 3 OlympiA trial.
PAOLA-1 trial principal investigator Isabelle Ray-Coquard said: “Ovarian cancer is a devastating disease. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful.
“The combination of Lynparza and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice.”
