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The combination of Poly (ADP-UC) polymerase inhibitors and immunotherapy has shown anti-tumor activity in preclinical studies.
MEDIOLA trial is a multi-center, open-label Phase 1/2 trial that evaluates the efficacy of olaparib's joint durvalumab therapy for solid tumors.
patients were recruited to 4 initial cohorts (embryo BRCA mutation, metastatic breast cancer; embryo BRCA mutation, metastatic ovarian cancer; metastatic gastric cancer and metastatic small cell lung cancer).
this paper reports on the efficacy and safety of the breast cancer cohort, the Olapali combined PD-L1 inhibitor durvalumab, in patients with metastatic breast cancer carrying the BRCA1 mutation or BRCA2 mutation.
the queue recruited 34 patients with metastatic breast cancer with BRCA1/2 embryo mutations, 300 mg Olapali (oral, 2/day) and 1.5 g durvalumab (static drop, 1/4 week) until the disease progressed.
end points are safety and tolerance, as well as disease control rates at 12 weeks.
11 (32%) patients had 3/4 levels of adverse reactions, the most common of which were anemia (4 cases (12%)), reduction of neutral granulocytes (3 s 9%)) and pancreatitis (2 s 6%).
patients were treated for side effects, and four (12%) experienced six severe adverse reactions.
no treatment-related deaths.
24 (80%) of the 30 patients who could be analyzed for efficacy were disease control at 12 weeks.
summary: Olapali combined durvalumab showed similar anti-tumor activity and safety observed in previous single-drug treatments.
it is worth further randomized controlled studies to verify the efficacy of the joint program.
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