Results from the study showed antitumor activity and safety to be similar to olaparib and durvalumab monotherapy study findings.
Results from a study published in The Lancet found promising antitumor activity and safety for the combination of olaparib and durvalumab in treating germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.
According to the findings, the MEDIOLA trial demonstrated that the antitumor and safety results of the combination therapy were comparable to those previously observed in olaparib and durvalumab monotherapy studies, according to the study’s authors.
The multi-center, open-label, phase 1/2, basket trial that included 34 patients between June 14, 2016 and May 2, 2017. Patient profiles were directed to 4 cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer. Patients with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centers in the United Kingdom, the United States, Israel, France, Switzerland, and South Korea.
Participants received 300 mg olaparib in oral tablet form 2 times daily for 4 weeks; after 4 weeks, patients received a combination of olaparib 300 mg twice daily and intravenous (IV) infusion of durvalumab 15 g every 4 weeks until disease progression.
Thirty-two percent of participants experienced grade 3 or worse adverse events (AEs); the most common AEs included anemia (12%), neutropenia (9%), and pacreatitis (6%). There were no treatment-related deaths. 24 of 30 patients who were eligible for activity analysis showed disease control at 12 weeks.
Investigators wrote that further research in a randomized controlled trial (RCT) is necessary to determine therapeutic benefit and long-term clinical outcomes compared to olaparib monotherapy.