AstraZeneca and Merck announced that the combination treatment of olaparib with bevacizumab to treat adult patients with advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer was approved in the European Union.
Olaparib (Lynparza) in combination with bevacizumab (Avastin) has been approved in the European Union as a first-line maintenance treatment for adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, according to a press release from AstraZeneca and Merck.
The patients included are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
“Half of all newly diagnosed patients with advanced ovarian cancer have HRD-positive tumors,” Dave Fredrickson, executive vice president of AstraZeneca, said in a press release. “Women treated with Lynparza in combination with bevacizumab in the PAOLA-1 Phase 3 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 personalized first-line treatment regimen for patients to substantially delay relapse in this devastating disease.”
The combination’s approval was based on data from a biomarker subgroup analysis of the PAOLA-1 phase 3 trial. The data showed that the combination of olaparib with bevacizumab demonstrated a progression-free survival (PFS) benefit compared to bevacizumab alone for patients with HRD-positive advanced ovarian cancer.
The trial’s data, published in The New England Journal of Medicine, revealed that the combination maintenance treatment reduced the risk of disease progression or death by 67% (HR, 0.33; 95% CI, 0.25-0.45), while the addition of olaparib to bevacizumab improved PFS to a median of 37.2 months compared to 17.7 months for bevacizumab alone.
Adverse events (AEs) occurring in more than 10% of patients in PAOLA-1’s population treated with olaparib combined with bevacizumab included fatigue (53%), nausea (53%), anemia (41%), lymphopenia (24%), vomiting (22%), and leukopenia (18%). More, grade 3 or higher AEs included anemia (17%), lymphopenia (7%), fatigue (5%), nausea (2%), leukopenia (2%), and vomiting (2%).
The research also found that serious AEs occurred in 31% of patients receiving the olaparib combination, while fatal AEs occurred in 1 patient due to concurrent pneumonia and aplastic anemia.
“Biomarker testing has rapidly enhanced our understanding of how PARP inhibition can help target this devastating disease,” Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, said in a press release. “The EU approval reinforces that HRD-positive tumors represent a distinct subset of advanced ovarian cancer and HRD testing is critical for women in this setting.”
LYNPARZA® (olaparib) in Combination with Bevacizumab Approved in the EU as First-Line Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer [news release]. Kenilworth, New Jersey. Published November 5, 2020. http://www.digitaljournal.com/pr/4867462. Accessed November 6, 2020.