Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy

Kite制药CAR-T疗法KTE-X19向FDA提交上市申请

2019-12-12 14:16:59 BioSpace

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-- Investigational KTE-X19 To Be First Chimeric Antigen Receptor T Cell Therapy for Mantle Cell Lymphoma if Approved -- -- Filing for Kite’s Second CAR T Therapy Marks Potential Expansion of Company’s Cell Therapy Portfolio -- SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, a Gilead Sciences Company (Nasdaq: GILD), today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The BLA submission is based on data from the Phase 2 ZUMA-2 trial, which demonstrated an overall response rate of 93 percent, including 67 percent with complete response, as assessed by an Independent Radiologic Review Committee (IRRC) following a single infusion of KTE-X19. In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando. “There remains a significant need for new treatments for patients with relapsed/refractory MCL despite recent advances, so this regulatory filing is an especially important milestone for the MCL community,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “We look forward to working with the FDA to bring KTE-X19 to appropriate patients as quickly as possible and continuing to deliver on the promise of our industry-leading cell therapy development program with a second CAR T therapy.” Kite plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) by the European Medicines Agency (EMA) for relapsed or refractory MCL. KTE-X19 is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov. About MCL MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and typically affects men over the age of 60. About ZUMA-2 ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an IRRC. Secondary endpoints include duration of response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing. About KTE-X19 KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP™ manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies with evidence of circulating lymphoblasts. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). About Kite Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com. About Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com. Forward-Looking Statement This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that FDA and other regulatory agencies may not approve KTE-X19 for the treatment of adult patients with relapsed or refractory MCL, and any marketing approvals, if granted, may have significant limitations on its use. In addition, Kite may not be able to submit the Marketing Authorization Application for KTE-X19 to the European Union in the currently anticipated timeline, or at all. There is also the possibility of unfavorable results from other ongoing and additional clinical trials involving KTE-X19. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements. XLP is a trademark of Gilead Sciences, Inc., or its related companies. For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20191211005861/en/ Greg Mann, Investors (424) 322-1795 Nathan Kaiser, Media (650) 522-1853 Source: Kite, a Gilead Company View this news release online at: http://www.businesswire.com/news/home/20191211005861/en
--研究 KTE-X19是否为首位 Chimeric 抗原受体 T 细胞治疗 Manll 细胞淋巴瘤(如获批准)- -- Kite 的第二个 CAR T 治疗标志着公司细胞治疗产品组合的潜在扩展-- 基特制药,吉利德科学(Gilead Sciences)公司(纳斯达克代码: GILD )今天宣布,它已提交了一份生物技术许可申请( BLA )给美国食品药品监督管理局(Food and Drug Administration)( FDA ),用于研究嵌合抗原受体( CAR ) T 细胞治疗, KTE-X19,用于治疗成人复发或难治性地幔细胞淋巴瘤( MCL )。 BLA 的提交是基于第二阶段 ZUMA-2试验的数据,该试验显示了93%的总体反应速率,包括67%的完全反应速率,这是由一个独立的放射审查委员会( IRRC )在单次注入 KTE-X19后评估的。在安全性分析中,15%和31%的患者出现3级或更高级别的细胞因子释放综合征( CRS )和神经事件。未发生5级 CRS 或神经事件。最近,在奥兰多举行的第61届美国血液学会年会上公布了这项试验的详细结果。 Kite 全球临床开发总监 Ken Takeshita 医学博士表示:“尽管最近取得了一些进展,但对于复发/难治性 MCL 患者仍然需要新的治疗方法,因此这份监管申报对于 MCL 社区来说是一个特别重要的里程碑。”“我们期待着与 FDA 合作,尽快将 KTE-X19带给合适的患者,并继续履行我们行业领先的细胞治疗开发计划的承诺,提供第二种 CAR T 疗法。” Kite 计划于2020年初在欧盟提交 KTE-X19上市许可申请。KTE-X19已被 FDA 和欧洲药品管理局( EMA )授予复发或难治性 MCL 的优先药物( PRIME )突破性治疗指定( BTD )。 KTE-X19是一项调查,并未在全球任何地方获得批准。其有效性和安全性尚未确定。有关 KTE-X19临床试验的更多信息,请访问 www.clinicalrials.gov 。 关于 MCL MCL 是一种罕见的非霍奇金淋巴瘤( NHL ),起源于淋巴结“地幔区域”的细胞,通常影响60岁以上的男性。 关于 ZUMA-2 ZUMA-2是一项单臂、多中心、开放标签的第2期研究,涉及74名成年患者(≥18岁)的 MCL 患者,其疾病难以治愈或已经复发,包括蒽环类或含有苯达莫司汀的化疗前五个疗程,抗 CD20单克隆抗体治疗及 BTK 抑制剂 ibrutinib 或 acablutinib 。本研究的目的是评价 KTE-X19单次输注后的疗效(60例)和安全性(68例)。研究的主要终点是客观反应率( ORR )。本试验的 ORR 定义为 IRRC 评估的完整反应和部分反应的综合比率。 次要终点包括反应持续时间、无进展生存、整体生存、不良事件发生率、抗 CD19 CAR 抗体发生率、血液中抗 CD19 CAR T 细胞水平、血清细胞因子水平以及随时间推移 EQ-5D 评分和视觉模拟评分的变化。这项研究正在进行中。 关于 KTE-X19 KTE-X19是一种研究、自体、抗 CD19 CAR T 细胞疗法。KTE-X19采用了 XLP ™制造工艺,包括 T 细胞选择和淋巴细胞富集。淋巴细胞富集是某些 B 细胞恶性肿瘤的必要步骤,有循环淋巴母细胞的证据。KTE-X19目前正处于急性淋巴细胞白血病( ALL )、地幔细胞淋巴瘤( MCL )和慢性淋巴细胞白血病( CLL )的1/2期试验中。 关于风筝 Kite 是吉利德(Gilead)公司,是一家位于加州圣莫尼卡的生物制药公司。Kite 从事开发创新的癌症免疫疗法。公司专注于嵌合抗原受体和 T 细胞受体工程细胞治疗。有关 Kite 的更多信息,请访问 www.kitemparma.com 。 关于吉利德科学(Gilead Sciences) 吉利德科学(Gilead Sciences), Inc .是一家以研究为基础的生物制药公司,在未满足医疗需求的领域发现、开发和商业化创新药物。该公司致力于改造和简化世界各地患有危及生命的疾病的人的护理。吉利德(Gilead)的业务遍及全球35个国家,总部位于加利福尼亚州的福斯特。有关吉利德科学(Gilead Sciences)的更多信息,请访问公司网站 www.giead.com 。 前瞻性陈述 本新闻稿包括前瞻性声明,在1995年《私人证券诉讼改革法案》的含义范围内,这些声明受到风险、不确定性和其他因素的影响,包括 FDA 和其他监管机构可能不批准 KTE-X19用于治疗复发或难治性 MCL 成人患者的风险。任何营销批准,如果被批准,可能对其使用有重大限制。此外, Kite 可能无法在当前预期的时间表中向欧盟提交 KTE-X19的营销授权申请,或者根本无法提交。此外,还可能出现其他正在进行的和涉及 KTE-X19的额外临床试验的不利结果。除历史事实陈述以外的所有陈述均可视为前瞻性陈述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性陈述中提及的结果存在重大差异。读者应注意不要依赖这些前瞻性陈述。这些风险和其他风险在吉利德(Gilead)提交给美国证券交易委员会的截至2019年9月30日的季度10-Q 季报中详细描述。所有前瞻性陈述均基于 Gilead 和 Kite 目前可获得的信息,吉利德(Gilead)和 Kite 不承担更新任何此类前瞻性陈述的义务。 XLP 是吉利德科学(Gilead Sciences), Inc .或其关联公司的商标。 有关 Kite 的更多信息,请访问该公司网站 www.kitemparma.com 或致电吉利德(Gilead) Public Affairs 1-800-GILEAD-5或1-650-574-3000。关注 Kite 在 Twitter (@ KitePharma )和 LinkedIn 上的社交媒体。 查看 businesswire 上的源代码。com : https://www.businesswire.com/news/home/2019121005861/en/ Greg Mann ,投资者 (424)322-1795 Nathan Kaiser , Media (650)522-1853 资料来源: Kite ,吉利德(Gilead)公司 在线查看本新闻稿,网址为: http://www.businesswire.com/news/home/2019121005861/en

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