Phase III POLO trial of Lynparza in pancreatic cancer published in NEJM.
AstraZeneca and Merck Inc. announced detailed results from the Phase III POLO trial evaluating Lynparza (olaparib) tablets as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease had not progressed following platinum-based chemotherapy. Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 47% (HR 0.53 [95% CI 0.35-0.82], p=0.004). The median PFS for patients treated with Lynparza was 7.4 months compared to 3.8 months for those on placebo, with more than twice as many patients remaining progression free at both one year (34% on Lynparza vs. 15% on placebo) and two years (22% vs. 10%) respectively.
The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials. The most common adverse events (AEs) at least 20% were fatigue/asthenia (60%), nausea (45%), abdominal pain (29%), diarrhea (29%), anemia (28%), decreased appetite (25%) and constipation (23%). The most common at least grade 3 AEs were anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). Around 84% of patients on Lynparza remained on the recommended starting dose, while 16% had a dose reduction vs. 97% who remained on the recommended dose with placebo, while 3% had a dose reduction. Additionally, 95% of patients on Lynparza continued treatment without an AE-related discontinuation, while 5% had an AE-related discontinuation vs. 98% who continued treatment without an AE-related discontinuation and 2% that had an AE-related discontinuation with placebo. The results of the trial will be featured at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The results will also be published online simultaneously in the New England Journal of Medicine (NEJM).
See: "Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer" Talia Golan et al. NEJM June 2, 2019, DOI: 10.1056/NEJMoa1903387
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.