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Olaparib extends PFS in pancreatic cancer subset
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A randomized phase 3 trial designed to evaluate olaparib as first-line maintenance therapy for patients with germline BRCA-mutated metastatic pancreatic cancer met its primary endpoint of PFS.
Olaparib (Lynparza; AstraZeneca, Merck) is a PARP inhibitor approved in the United States for treatment of certain patients with ovarian cancer and HER2-negative metastatic breast cancer.
The double-blind, placebo-controlled POLO evaluated the efficacy of olaparib tablets as first-line maintenance monotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer whose disease had not progressed on platinum-based chemotherapy.
Results showed patients assigned olaparib demonstrated significantly reduced risk for progression or death than those assigned placebo. Olaparib’s safety profile appeared consistent with that observed in prior studies.
“This is the first positive phase 3 trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need,” José Baselga, MD, PhD, executive vice president of research and development for oncology at AstraZeneca, said in a press release. “Most patients are diagnosed late, leaving them with a poor prognosis and very limited treatment options. Based on POLO, Lynparza becomes the first PARP inhibitor to demonstrate positive phase 3 results beyond ovarian cancer and breast cancer.”
Full data from POLO will be presented at an upcoming medical meeting.
“The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer,” Roy Baynes, MD, PhD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in the release. “We will discuss these results with global health authorities as soon as possible.”