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95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. Median progression free survival (mPFS) was 12.9 months as of the July 17, 2023 data cut-off90% overall response rate observed in relapsed/refractory multiple myeloma at the therapeutic dose including patients with, and without prior BCMA-targeted therapyClass-Leading Response Rate in BCMA-exposed patients (frequently excluded from BCMA CAR-T clinical trials) has the potential to meet an important market needNexcella plans to submit a BLA for FDA approval in multiple myeloma once 100 patients are treated with NXC-201The expected primary endpoints for NXC-201 in relapsed/refractory multiple myeloma are overall response rate and duration of response LOS ANGELES, Oct.
在未接受BCMA靶向治疗的复发/难治性多发性骨髓瘤患者中观察到95%的总有效率。截至2023年7月17日,中位无进展生存期(mPFS)为12.9个月,数据截止到治疗剂量时复发/难治性多发性骨髓瘤的总有效率为90%,并且在没有BCMA靶向治疗周期的情况下,BCMA暴露患者(经常被排除在BCMA CAR-T临床试验之外)的领先反应率有可能满足重要的市场需求NexCella计划在100名患者中提交BLA以获得FDA批准用于多发性骨髓瘤用NXC-201治疗复发/难治性多发性骨髓瘤中NXC-201的预期主要终点是整体回应率和回应持续时间洛杉矶,10月。
02, 2023 (GLOBE NEWSWIRE) -- Nexcella Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the presentation of updated data from the ongoing Phase 1b/2 NEXICART-1 (NCT04720313) study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. The updated dataset consists of 63 multiple myeloma patients (including data on 13 new patients and continued follow-up data on 50 previously enrolled patients), at a poster presentation at the 20th International Myeloma Society Annual Meeting in Athens, Greece on September 27-30, 2023 (72 patient count includes 9 AL Amyloidosis patients which will be announced separately).
022023(GLOBE NEWSWIRE)-Nexcella Inc.(“Nexcella”,“Company”,“We”或“Us”)今天宣布提供正在进行的1b/2期NEXICART-1的更新数据。(NCT04720313)研究其新型,自体,BCMA靶向嵌合抗原受体T(CAR-T)细胞疗法NXC-201。更新后的数据集由63名多发性骨髓瘤患者组成(包括13名新患者的数据和50名先前入选患者的持续随访数据),于9月27日至2023年9月在希腊雅典举行的第20届国际骨髓瘤学会年会上的海报介绍(72名患者包括9名AL淀粉样变性患者,将单独宣布)。
'We continue to be very encouraged by NXC-201 clinical results,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. “We feel these overall response rate data are compelling as 72% .
Hadassah医学组织成人和儿童骨髓移植和免疫治疗系主任Polina Stepensky博士和首席研究研究员说:“我们继续受到NXC-201临床结果的鼓舞。”。“我们认为这些总体回应率数据令人信服,为72%。
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Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma
Nexcella在IMS第20届年会上宣布72位患者NXC-201临床数据,多发性骨髓瘤的总体反应率为95%