Abstract：
Parsaclisib, a potent and highly selective phosphoinositide 3-kinase δ inhibitor, has shown clinical activity in relapsed/refractory (R/R) B-cell lymphoma. The phase 1 CITADEL-112 (NCT03424122) study assessed safety and efficacy of parsaclisib in combination with investigator choice standard of care (SOC; rituximab [Treatment A], rituximab plus bendamustine [Treatment B], or ibrutinib [Treatment C]) in 50 patients with R/R B-cell lymphoma. The most common treatment-emergent adverse events included neutropenia (62.5%, 50.0%, and 50.0% of patients in Treatments A, B, and C, respectively); diarrhea (37.5%) and anemia (31.3%) in Treatment A; abdominal pain, asthenia, diarrhea, and nausea (each 33.3%) in Treatment B; and increased alanine and aspartate aminotransferase (each 37.5%) in Treatment C. Objective responses were observed in 13 patients (81.3%) in Treatment A, 10 (55.6%) in Treatment B, and 8 (50.0%) in Treatment C. Parsaclisib combined with SOC therapies had an expected safety profile and promising efficacy in patients with R/R B-cell lymphomas.
摘要：
Parsaclisib,一种有效和高度选择性的磷酸肌醇3-激酶δ抑制剂，已在复发性/难治性（R/R）B细胞淋巴瘤中显示出临床活性。1CITADEL-112期（NCT03424122）研究评估了parsaclisib与研究者选择的护理标准（SOC；利妥昔单抗[治疗A]，利妥昔单抗加苯达莫司汀[治疗B]，或依鲁替尼[治疗C]）治疗50例R/RB细胞淋巴瘤患者。最常见的治疗引起的不良事件包括中性粒细胞减少症（62.5%，50.0%,治疗A的50.0%的患者，B,C,分别）；治疗A中的腹泻（37.5％）和贫血（31.3％）；腹痛，虚弱,腹泻,治疗B中的恶心（各33.3％）；治疗C中的丙氨酸和天冬氨酸转氨酶增加（各37.5％）。治疗A中的13例患者（81.3％）观察到客观反应，治疗B中10例（55.6%），和8(50.0%)在治疗C.Parsaclisb联合SOC疗法在R/RB细胞淋巴瘤患者中具有预期的安全性和有希望的疗效。
