Dr. Richards on the Phase III POLO Trial in BRCA-Mutated Pancreatic Cancer

Donald A. Richards, MD, PhD
Published: Friday, Sep 20, 2019



Donald A. Richards, MD, PhD, medical oncologist, Texas Oncology, discusses the design and findings of the phase III POLO trial in patients with pancreatic cancer.

In the trial, investigators evaluated the use of olaparib (Lynparza) as maintenance therapy in patients with advanced pancreatic cancer who harbored a BRCA1/2 mutation. After screening 3315 patients with pancreatic cancer, investigators identified 247 patients with germline mutations, says Richards. In order to be eligible for enrollment, patients had to have received 4 months of platinum-based chemotherapy, and have stable disease or be in partial remission.

Patients were randomized 3:2 to receive oral olaparib tablets at 300 mg twice daily (n = 92) versus placebo (n = 62). The primary endpoint of the study was progression-free survival (PFS). The results, which were presented at the 2019 ASCO Annual Meeting, showed a median PFS of 7.4 months and 3.8 months with olaparib and placebo, respectively, which translated to a 47% reduction in the risk of progression or death. Overall survival (OS) was a key secondary endpoint. At the time of analysis, there did not appear to be a difference between arms in terms of OS. However, these data are immature and require further follow-up, says Richards.
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Donald A. Richards, MD, PhD, medical oncologist, Texas Oncology, discusses the design and findings of the phase III POLO trial in patients with pancreatic cancer.

In the trial, investigators evaluated the use of olaparib (Lynparza) as maintenance therapy in patients with advanced pancreatic cancer who harbored a BRCA1/2 mutation. After screening 3315 patients with pancreatic cancer, investigators identified 247 patients with germline mutations, says Richards. In order to be eligible for enrollment, patients had to have received 4 months of platinum-based chemotherapy, and have stable disease or be in partial remission.

Patients were randomized 3:2 to receive oral olaparib tablets at 300 mg twice daily (n = 92) versus placebo (n = 62). The primary endpoint of the study was progression-free survival (PFS). The results, which were presented at the 2019 ASCO Annual Meeting, showed a median PFS of 7.4 months and 3.8 months with olaparib and placebo, respectively, which translated to a 47% reduction in the risk of progression or death. Overall survival (OS) was a key secondary endpoint. At the time of analysis, there did not appear to be a difference between arms in terms of OS. However, these data are immature and require further follow-up, says Richards.

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