Dr. Richards on Secondary Endpoints of the POLO Trial in Pancreatic Cancer

Donald A. Richards, MD, PhD, medical oncologist, Texas Oncology, discusses the secondary endpoints of the randomized, double-blind, phase III POLO trial, which evaluated maintenance therapy with olaparib (Lynparza) in patients with germline BRCA-mutated, metastatic pancreatic cancer.

Secondary endpoints include overall survival, time to second progression or death,objective response rate, disease control rate, safety, and tolerability.

After 24-months, 33.7% of patients treated with olaparib showed no signs of disease progression compared with 14.5% of patients in the placebo arm. The risk of disease progression with olaparib was reduced by 47% (HR, 0.53) versus placebo.

Olaparib was generally well tolerated and quality of life was not compromised as a result of treatment. Grade ≥3 adverse events (AEs) were reported in 40% of patients on olaparib compared with 23% of those in the placebo arm. Notably, 5.5% and 1.7% of patients discontinued treatment due to an AE in the olaparib and placebo arms, respectively.

Results from the POLO trial have had a significant impact on the treatment paradigm. Olaparib induced a significant response rate and demonstrated durable responses in this space, Richards concludes. This highlights the need for genetic testing to identify patients with BCRA1/2-mutated pancreatic cancer.