Kite : Yescarta Quadruples Median Event-Free Survival Duration In Refractory Large B-Cell Lymphoma


2021-12-12 00:00:12 RTTNews


Kite, a Gilead Company , said that yescarta CAR T-Cell Therapy Quadruples Median Event-Free Survival Duration Over Standard of Care in Second-Line Relapsed or Refractory Large B-Cell Lymphoma. The primary analysis of ZUMA-7, a global Phase 3 study evaluating Yescarta (axicabtagene ciloleucel) as a one-time infusion, in a head-to-head study against standard of care (SOC) for adults with large B-cell lymphoma (LBCL) who relapsed or were refractory to first-line treatment. Yescarta was evaluated against the current SOC which is a multi-step process intended to culminate in a stem cell transplant. ZUMA-7 was initiated in 2017 and is the first and largest Phase 3 randomized study of any CAR T-cell therapy in the second-line setting, enrolling 359 patients in 77 centers around the world. ZUMA-7 is considered a landmark trial for being the only study to reach the clinically meaningful two-year follow-up milestone. The company said that, with a median follow-up of over two years, the study met the primary endpoint of event-free survival. Yescarta demonstrated a 2.5 fold increase in patients who were alive at two years and did not require the need for additional cancer treatment or experienced cancer progression and a four-fold greater median Event-Free Survival compared to Standard of Care. These statistically significant and clinically meaningful results were not confounded by any bridging chemotherapy. Global regulatory filings to expand the indication for Yescarta to include second-line relapsed or refractory LBCL based on the ZUMA-7 data are currently underway. The U.S. Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation to Yescarta for this patient population with a target action date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2022. Regulatory submissions have also been filed with other global health authorities, including the European Medicines Agency. For comments and feedback contact: Business News
Gilead公司Kite表示,yescarta汽车T细胞疗法将二线复发或难治性大B细胞淋巴瘤的中位无事件生存期提高了四倍。 ZUMA-7的初步分析,这是一项评估Yescarta(axicabtagene ciloleucel)作为一次性输注的全球3期研究,在一项针对复发或一线治疗难治的成人大B细胞淋巴瘤(LBCL)的标准护理(SOC)的头部对头部研究中。对Yescarta的评价与目前的SOC是一个多步骤的过程,旨在达到干细胞移植的高潮。 ZUMA-7启动于2017年,是第二线环境中第一个也是最大的任何CAR T细胞治疗的3期随机研究,在世界各地77个中心招募了359名患者。ZUMA-7被认为是一项里程碑式的试验,因为它是唯一一项达到有临床意义的两年随访里程碑的研究。 该公司表示,在超过两年的中位随访中,该研究满足了无事件生存的主要终点。Yescarta显示,与标准护理相比,活两年、不需要额外癌症治疗或经历癌症进展的患者增加了2.5倍,中位无事件生存期增加了4倍。这些具有统计学意义和临床意义的结果没有被任何桥接化疗所混淆。 根据ZUMA-7数据,全球监管机构正在提交文件,以扩大Yescarta的适应症,包括二线复发或难治性LBCL。 美国食品药品监督管理局已经接受了补充生物制品许可申请(sBLA),并根据2022年4月1日的《处方药使用者费用法》(PDUFA)批准了Yescarta对该患者群体的优先审查指定。 还向包括欧洲药品管理局在内的其他全球卫生当局提交了监管文件。 如需评论和反馈,请联系 商业新闻