AstraZeneca and Merck have reported positive data from the Phase III POLO clinical trial of Lynparza (olaparib) as a first-line maintenance monotherapy in pancreatic cancer patients.
The trial met its primary endpoint of demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) when treated with Lynparza, compared to placebo.
In addition, the safety and tolerability profile of the drug was found to be consistent with previous data.
Lynparza is a PARP inhibitor designed as a targeted treatment to block DNA damage response in cells / tumours harbouring a deficiency in homologous recombination repair (HRR), including BRCA1 and/or BRCA2 mutations.
The randomised, double-blinded, placebo-controlled POLO trial assessed Lynparza tablets in 154 germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma patients whose disease has not progressed on first-line platinum-based chemotherapy.
While the trial’s primary endpoint was PFS, its secondary endpoints included overall survival, time to second disease progression, disease control rate, overall response rate and health-related quality of life.
AstraZeneca Oncology Research and Development executive vice-president José Baselga said: “This is the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need.
“The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these results with global health authorities as soon as possible.”
The company has also reported that its Phase III THEMIS trial assessing Brilinta (ticagrelor) in conjunction with aspirin met the primary endpoint with a statistically significant decrease in a composite of major adverse cardiovascular events (MACE), compared to aspirin alone.
Brilinta is an oral, reversible P2Y12 receptor antagonist that inhibits platelet activation.
The multinational, randomised, double‑blinded THEMIS trial was intended to evaluate the use of the drug along with aspirin in more than 19,000 patients with coronary artery disease (CAD) and type-2 diabetes (T2D) without any previous heart attack or stroke.