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ADC Therapeutics宣布LOTIS-7临床试验的最新进展,该试验评估ZYNLONTA®联合吉非他单抗或莫舒妥珠单抗治疗复发/难治性B细胞非霍奇金淋巴瘤

ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

GlobeNewswire 等信源发布 2024-04-04 19:00

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Dose escalation in Phase 1b trial completed with no dose-limiting toxicities, no or low-grade cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome across all patients and early signs of anti-tumor activity Enrollment in Part 2 dose expansion has been initiated LAUSANNE, Switzerland, April 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).

1b期试验的剂量递增已于2024年4月4日在瑞士洛桑启动,所有患者均无剂量限制性毒性,无或低度细胞因子释放综合征,无免疫效应细胞相关神经毒性综合征,第2部分剂量扩展的抗肿瘤活性登记的早期迹象(GLOBE NEWSWIRE)——ADC Therapeutics SA(NYSE:ADCT)今天宣布完成LOTIS-7的剂量递增,LOTIS-7是一项1b期开放标签临床试验,评估ZYNLONTA®(loncastuximab tesirine lpyl)联合双特异性抗体glofitamab或mosunetuzumab治疗重度复发/难治性B患者-细胞非霍奇金淋巴瘤(r/r B-NHL)。

In the dose escalation portion (Part 1) of LOTIS-7, no dose-limiting toxicities (DLTs), no or low-grade cytokine release syndrome (CRS) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed across all patients when ZYNLONTA was administered in combination with glofitamab or mosunetuzumab.

在LOTIS-7的剂量递增部分(第1部分)中,当ZYNLONTA与glofitamab或mosunetuzumab联合给药时,所有患者均未观察到剂量限制性毒性(DLT),无或低度细胞因子释放综合征(CRS)和免疫效应细胞相关神经毒性综合征(ICANS)。

Additionally, after the first investigator assessment, evidence of anti-tumor activity was observed among the majority of patients, with mixed histologies including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). Based on the data from Part 1, all three dose levels (90, 120 and 150 µg/kg) have now been cleared and enrollment in Part 2 dose expansion has been initiated with ZYNLONTA administered in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in 2L+ DLBCL.

此外,在第一次研究者评估后,在大多数患者中观察到抗肿瘤活性的证据,其混合组织学包括弥漫性大B细胞淋巴瘤(DLBCL),滤泡性淋巴瘤(FL)和边缘区淋巴瘤(MZL)。根据第1部分的数据,所有三个剂量水平(90120和150µg/kg)现在都已被清除,第2部分剂量扩展的登记已经开始,ZYNLONTA与glofitamab联合使用120µg/kg和150µg/kg剂量水平的2L+DLBCL。

“The early data from Part 1 of our LOTIS-7 trial highlight the potential combinability of ZYNLONTA with bispecifics in lymphoma patients,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. “We look forward to the con.

ADC Therapeutics首席医学官Mohamed Zaki博士说:“我们LOTIS-7试验第一部分的早期数据突出了ZYNLONTA与淋巴瘤患者双特异性药物的潜在结合性。”。“我们期待着胜利。