Olaparib Plus Durvalumab Treatment of BRCA-Mutant Ovarian Cancer: MEDIOLA Trial
Posted: Tuesday, November 26, 2019
Combination treatment using the PARP inhibitor olaparib and the anti–PD-L1 antibody durvalumab appears to be well tolerated and active in terms of progression-free survival and duration of response in patients with BRCA1- or BRCA2-mutated platinum-sensitive relapsed ovarian cancer. Yvette Drew, MBBS, PhD, of the Northern Institute for Cancer Research, Newcastle upon Tyne, presented the findings of the phase II MEDIOLA trial at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract 1190PD) and published them in the Annals of Oncology.
The study recruited patients with BRCA1- or BRCA2-mutated platinum-sensitive relapsed ovarian cancer who had received at least one prior line of platinum-based therapy. Patients received 300 mg of olaparib twice a day for a 4-week run-in, then received 300 mg of olaparib twice daily plus 1.5 g of durvalumab intravenously every 4 weeks until disease progression.
At the data cutoff of November 1, 2018, 28% of the 32 enrolled patients were still on treatment. The 28-week disease control rate was 65.6%, and the overall response rate was 71.9%, with seven patients achieving a complete response. The median progression-free survival was 11.1 months, and the median duration of response was 10.2 months. At 24 months, 87% of the patients enrolled were alive, and the overall survival for all patients was not yet reached. A total of 13 patients in the trial were receiving the drug as a second-line therapy, and these patients had not yet reached the medians for progression-free survival or duration of response. The authors suggested this may mean that those with fewer prior lines of chemotherapy may benefit more from this regimen.
The most common grade 3 or higher adverse events included anemia, elevated lipase levels, neutropenia, and lymphopenia. Five patients discontinued olaparib treatment, and three discontinued durvalumab because of an adverse event.
Disclosure: For full disclosures of the study authors, visit academic.oup.com.