(Breast Cancer) Is Imfinzi + Lynparza Effective?
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On August 6, 2020, Susan M. Domchek published in The Lancet the efficacy and safety results of the MEDIOLA Phase 1/2 clinical trial evaluating anti-PD-L1 antibody Imfinzi (durvalumab) + PARP inhibitor Lynparza (olaparib) in BRCA1/BRCA2 mutation-positive breast cancer patients.
The MEDIOLA trial was an open-label multicenter trial. BRCA1/BRCA2 mutation-positive breast cancer, ovarian cancer, gastric cancer, and recurrent small cell lung cancer patients received Imfinzi (1500mg) + Lynparza (300mg twice daily) combination therapy in 4-week cycles. Primary endpoints were safety, tolerability, and 12-week disease control rate. Breast cancer patients were required to have received at least 2 previous chemotherapy regimens to participate.
Previous clinical trials had confirmed that PARP inhibitors combined with VEGFR inhibitors showed higher anti-tumor efficacy. This trial evaluated the efficacy and safety of Imfinzi + Lynparza specifically in BRCA1/BRCA2 mutation-positive breast cancer patients.
In the analyzed 34 patients, the primary endpoint safety showed Grade 3+ adverse events in 32% (N=11 patients). The most common symptoms were anemia 12% (N=4), neutropenia 9% (N=3), and pancreatitis 6% (N=2). Treatment discontinuation rate due to adverse events was 12% (N=4), with no treatment-related deaths. Among 30 analyzed patients, the disease control rate at 12 weeks of treatment was 80%.
Based on MEDIOLA clinical trial results, Alice T. Shaw concluded that BRCA1/BRCA2 mutation-positive breast cancer patients showed good tolerability with anti-PD-L1 antibody Imfinzi + PARP inhibitor Lynparza combination, with promising anti-tumor efficacy. However, further research is needed to determine if Imfinzi combination therapy provides better long-term clinical outcomes than Lynparza monotherapy.
Source: Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study (Lancet Oncol. 2020 Aug 6;S1470-2045(20)30324-7. doi: 10.1016/S1470-2045(20)30324-7)
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