AbbVie Announces US FDA Lifts Partial Clinical Hold on Phase 3 Study of Venetoclax in Patients with Multiple Myeloma Positive for the t Genetic Abnormality

美国FDA解除对艾伯维Venetoclax治疗多发性骨髓瘤III期试验的部分临床限制

2019-06-25 12:05:00 PR Newswire

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AbbVie (ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on CANOVA (M13-494), a Phase 3 trial evaluating venetoclax (VENCLEXTA® OR VENCLYXTO®) for the investigational treatment of relapsed/refractory multiple myeloma. The CANOVA trial evaluates venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma positive for the translocation (11;14) abnormality. The t(11;14) genetic biomarker is among the most common and routinely tested genetic abnormalities in patients with multiple myeloma.1 The FDA removed the partial clinical hold based upon agreement on revisions to the CANOVA study protocol, including new risk mitigation measures, protocol-specified guidelines and updated futility criteria. Enrollment in the CANOVA trial may resume as determined by each participant site based on the approved protocol. All other clinical trials evaluating venetoclax in patients with multiple myeloma remain on partial clinical hold while next steps continue to be evaluated with the agency. The partial clinical hold does not impact any of the approved indications for venetoclax, such as chronic lymphocytic leukemia (CLL) or acute myeloid leukemia (AML). AbbVie remains confident in the benefit/risk profile of venetoclax in those approved indications. "We are pleased to move forward with the CANOVA study which, with the t(11;14) biomarker test, can help identify patients who may respond better to treatment and add clarity for physicians when choosing a therapy, if approved," said Mohamed Zaki, M.D., Ph.D., global head of hematology development, AbbVie. "We are working closely with regulatory authorities worldwide to continue our efforts to understand the potential of venetoclax for patients with multiple myeloma while continuing to advance research in patients with the t(11;14) genetic abnormality." Results from the Phase 3 BELLINI trial evaluating patients with relapsed/refractory multiple myeloma were presented at the 24th European Hematology Association (EHA) Annual Congress during the late-breaking oral presentation session on Sunday, June 16. Additional data will be presented at a future congress or published in a medical journal.2 In March 2019, AbbVie announced the FDA placed a partial clinical hold on all trials evaluating venetoclax for the investigational treatment of multiple myeloma, following a review of data from the Phase 3 BELLINI trial of venetoclax with bortezomib and dexamethasone (Ven + Vd) versus placebo (placebo + Vd) in patients with relapsed/refractory multiple myeloma, in which a higher proportion of deaths (41/194 (21%)) was observed in the venetoclax arm compared to the control arm of the trial (11/97 (11%) — overall survival hazard ratio (HR) 2.027, 95% confidence interval (CI): [1.042, 3.945]). Progressive disease was the most common cause (45%) of death. The rates of serious adverse events (AEs) (48% vs 50%) and serious infections (28% vs 27%) were comparable between arms.2  Venetoclax is not approved by any regulatory authority, in any country for the treatment of multiple myeloma. Despite the availability of multiple myeloma therapies, there is no optimal treatment sequence.3 Nearly all multiple myeloma patients eventually relapse, which is associated with poor outcomes, and each remission is typically shorter than the previous one.4 Patients with multiple myeloma have an average life expectancy of approximately five to six years after diagnosis.5 It is the second most common blood cancer with nearly 140,000 cases expected to be diagnosed worldwide this year.6,7 Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie ( ABBV ),一家以研究为基础的全球生物制药公司,今天宣布美国食品药品监督管理局(Food and Drug Administration)( FDA )解除了对 CANOVA ( M13-494)的部分临床持有。评估用于研究复发性/难治性多发性骨髓瘤的性病原体( VENTCLEXTA ®或 VENTCLYXTO ®)的第3阶段试验。CANOVA 试验评估在复发/难治性多发性骨髓瘤患者中与地塞米松联合应用地塞米松与泊马利度胺治疗转移(11;14)异常所致的单侧卵巢功能障碍。t (11;14)基因生物标记物是多发性骨髓瘤患者最常见的、常规检测的基因异常之一。1 FDA 根据对 CANOVA 研究方案的修订,包括新的风险缓解措施、协议规定的指南和更新的无效标准,取消了部分临床试验。在 CANOVA 试验中的注册可以恢复,由每个参与网站根据批准的协议确定。 所有其他评估多发性骨髓瘤患者单侧卵巢切除术的临床试验仍在部分临床上进行,下一步仍将由该机构进行评估。部分临床持有不影响任何批准的迹象,如慢性淋巴细胞白血病( CLL )或急性髓细胞性白血病( AML )。艾伯维(AbbVie)对已批准的适应症内的黄体酮的益处/风险状况仍有信心。 AbbVie 血液学发展全球负责人 Mohamed Zaki 博士说:“我们很高兴能继续进行 CANOVA 研究,该研究通过 t (11;14)生物标志物测试,可以帮助确定对治疗有更好反应的患者,并在选择治疗时为医生增加清晰度。“我们正与世界各地的监管机构密切合作,继续努力了解多发性骨髓瘤患者的促性腺激素的潜力,同时继续推进 t (11;14)基因异常患者的研究。” 第三阶段 BELLINI 试验的结果评价复发/难治性多发性骨髓瘤患者提出了在第24届欧洲血液学协会( EHA )年会期间,在周日,6月16日的晚期口头陈述会议。额外的数据将在未来的大会上提出或发表在医学杂志上。2 2019年3月,艾伯维(AbbVie)宣布 FDA 对所有评价单孢他啶用于研究治疗多发性骨髓瘤的试验进行部分临床试验。在回顾了第三阶段 BELLINI 试验的数据后,在复发/难治性多发性骨髓瘤患者中,与对照组相比,性病原体臂的死亡率(41/194(21%)更高(11/97(11%)—总体生存危险比( HR )2.027,95%置信区间( CI ):[1.042,3.945])相比,复发性/难治性多发性骨髓瘤患者的贴膏剂( Ven + Vd )与安慰剂(安慰剂+ Vd ):。进行性疾病是最常见的死亡原因(45%)。严重不良事件( AE )(48%对50%)和严重感染(28%对27%)的发生率在武器之间是可比的。 在任何国家,对于多发性骨髓瘤的治疗, Venetplax 都没有得到任何监管机构的批准。 尽管有多种骨髓瘤治疗方法,但没有最佳的治疗顺序。3几乎所有多发性骨髓瘤患者最终都会复发,这与不良结果有关,而且每次缓解通常比前一次要短。4例多发性骨髓瘤患者在确诊后平均预期寿命约为5至6年。这是第二大最常见的血癌,预计今年全世界将诊断出近14万例。6,7 Venetplax 正在由艾伯维(AbbVie)和罗氏(Roche)开发。它由罗氏(Roche)集团成员 AbbVie 和基因泰克(Genentech)在美国联合商业化,并由美国以外的艾伯维(AbbVie)联合商业化。

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