Results from the Phase III POLO trial have been announced. The trial demonstrated a statistically significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza® (olaparib) vs. placebo. The safety and tolerability profile of Lynparza was consistent with previous trials.
POLO is a randomized, double-blinded, placebo-controlled trial exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on platinum-based chemotherapy.
“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 tumor types. We will discuss these results with global health authorities as soon as possible,” commented José Baselga (AstraZeneca).
The clinical trial randomized 154 patients with germline BRCA-mutated metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy. Patients were randomized (3:2) to receive Lynparza or placebo until disease progression. The primary endpoint was PFS and key secondary endpoints included overall survival, time to second disease progression, overall response rate, disease control rate and health-related quality of life.
“Trials like POLO demonstrate the shared commitment of MSD and AstraZeneca to assess treatments for difficult-to-treat cancers. The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer,” added Roy Baynes from MSD Research Laboratories.