Predicting Benefit From Olaparib Maintenance in Metastatic Pancreatic Cancer: The POLO Trial
Based on results from the POLO trial,1,2 the BRACAnalysis CDx assay (Myriad Genetics) became capable of becoming aware of patients with metastatic pancreatic most cancers who benefitted from upkeep therapy with the poly [ADP ribose] polymerase (PARP) inhibitor olaparib, in step with press announcements released on February 26, 2019.1,3
The POLO have a look at is a phase 3, randomized, managed trial of olaparib monotherapy in 154 patients with metastatic pancreatic adenocarcinoma (with an ailment that had no longer progressed following first-line platinum-primarily based chemotherapy) who had been randomly assigned (three:2) to acquire two times-each day administration of 300 mg of olaparib or placebo.1,2
All patients who had been enrolled within the examination had a deleterious or suspected deleterious germline BRCA1/2 mutation recognized with the aid of the BRACAnalysis CDx assay. Thus, the number one stop factor of the POLO trial turned into development-free survival, with ordinary survival, ordinary response charge, protection, and fitness-associated first-class of life included as secondary give-up points.
Results from the POLO trial confirmed that it met its primary end factor of statistically drastic development in PFS whilst the olaparib arm became in comparison with the placebo arm. In addition, the safety and tolerability profiles of olaparib were just like results determined in previous trials of this agent in other cancers.1
“This is the primary high-quality section 3 trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic most cancers, a devastating ailment with crucial unmet need. The outcomes of POLO offer further proof of the scientific gain of [olaparib] across a spread of BRCA-mutated tumor kinds. We will talk about these outcomes with the international fitness government as quickly as possible,” said José Baselga, executive VP, research and improvement, Oncology at AstraZeneca.
The BRACAnalysis CDx test has previously received approval from the US Food and Drug Administration (FDA) as a companion diagnostic assay for figuring outpatients with superior breast and ovarian cancers who are candidates for the PARP inhibitor olaparib.3
AstraZeneca. Lynparza appreciably not on time ailment development as 1st-line preservation treatment in germline BRCA-mutated metastatic pancreatic cancer [press release]. Published February 26, 2019. Accessed February 28, 2019.
ClinicalTrials.Gov Identifier: NCT02184195. Olaparib in gBRCA mutated pancreatic cancer whose disease has no longer improved on first-line platinum-based totally chemotherapy (POLO). Updated January 29, 2019. Accessed February 28, 2019.
Myriad. Myriad’s BRACAnalysis CDx® test effectively-recognized sufferers with metastatic pancreatic cancer who benefitted from remedy with olaparib [press release]. Published on February 26, 2019. Accessed February 28, 2019.