Amgen Announces BLINCYTO® Five-Year Overall Survival Data At EHA 2019

安进公司Blincyto治疗MRD阳性急性淋巴细胞白血病总体生存期为36.5个月

2019-06-17 17:07:00 PR Newswire

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Amgen (AMGN) today announced the five-year overall survival (OS) analysis from the single-arm, Phase 2 BLAST study that evaluated BLINCYTO® (blinatumomab) in patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). The study found that with a median follow-up of 59.8 months, the median OS for BLINCYTO-treated patients was 36.5 months (95 percent CI: 22 months - not estimable [NE]). More than half of patients who achieved a complete MRD response following the first cycle of BLINCYTO treatment were alive at five years. These results from the largest prospective trial ever conducted in MRD-positive ALL were presented today during an oral presentation at the 24th Annual Congress of the European Hematology Association (EHA) in Amsterdam. "As the only CD19-targeted immuno-oncology therapy with five-year survival data, BLINCYTO continues to demonstrate compelling results for ALL patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are proud of the science behind our BiTE® technology. These data in an MRD-positive ALL patient population give us increased confidence in the clinical benefit of BLINCYTO, especially when these patients are treated earlier." The Phase 2 open-label BLAST study enrolled 116 patients with MRD-positive Philadelphia chromosome-negative (Ph-) B-cell precursor ALL in first or subsequent complete hematologic remission after at least three intensive chemotherapy blocks of treatment. Of the 116 enrolled patients, OS was evaluated for 110 patients with less than five percent leukemic blasts, including 74 patients who received hematopoietic stem cell transplantation (HSCT) in continuous complete remission (CCR) after BLINCYTO treatment. Results presented at EHA showed that in 84 patients who achieved a complete MRD response (had no measurable MRD), median OS was not reached (95 percent CI: 29.5 months - NE) compared to 14.4 months for those who had measurable MRD (n=23; 95 percent CI: 3.8 - 32.3 months). Among patients with MRD in first complete remission (CR1), median OS was not reached for those who achieved a complete MRD response (95 percent CI: 29.5 months - NE) versus 10.6 months (95 percent CI: 2.7 - 39.7 months) for those who did not achieve complete MRD response (n=13; p=0.008). "The presence of MRD is a strong predictor of relapse in patients with B-cell precursor ALL," said Nicola Gökbuget, M.D., principal investigator for the BLAST study and head of the German Multicenter Study Group for Adult ALL in Frankfurt, Germany. "Results from the final follow-up of the BLAST trial at five years demonstrate that early achievement of complete molecular remission with BLINCYTO is associated with prolonged survival." Safety results among MRD-positive patients were consistent with the known safety profile of BLINCYTO.   MRD refers to the presence of cancer cells that remain detectable, despite a patient having achieved complete remission by conventional assessment.1 The presence of MRD is broadly considered the most important independent prognostic factor in ALL.2-8 MRD is only measurable through the use of highly sensitive testing methods that detect cancer cells in the bone marrow with a sensitivity of at least one cancer cell in 10,000 cells – versus about one in 20 with a conventional microscope-based evaluation.1,9,10 BLINCYTO, a bispecific CD19-directed CD3 T cell BiTE® (bispecific T cell engager) molecule, is the first approved molecule from Amgen's BiTE immuno-oncology platform, and the first and only therapy to receive regulatory approval globally for the treatment of MRD. 
安进(Amgen)( AMGN )今天宣布从单臂第二期 BLAST 研究中进行五年总体生存( OS )分析,该研究评估了 BLINCYTO ®( blindatummaab )患者的最低残留疾病( MRD )-阳性急性淋巴细胞白血病( ALL )。研究发现,在平均随访59.8个月的情况下, BLINCOYTO 治疗的患者的平均 OS 为36.5个月(95% CI :22个月——不可估计[ NE ])。在第一个周期 BLINCYTO 治疗后获得完全 MRD 反应的患者中,有一半以上在五年内存活。今天,在阿姆斯特丹举行的第24届欧洲血液学协会年会上,在一次口头报告中介绍了有史以来最大的 MRD 阳性 ALL 前瞻性试验的结果。 “作为唯一的 CD19靶向免疫肿瘤治疗与五年生存数据, BLINCYTO 继续显示出令人信服的结果,为所有患者,”大卫 M.Reese ,医学博士(M.D.)博士,执行副总裁研究和发展在安进(Amgen)。“我们对 BiTE ®技术背后的科学感到自豪。在 MRD 阳性的 ALL 患者群体中,这些数据使我们对 BLINCOYTO 的临床益处有了更大的信心,尤其是在这些患者接受更早治疗的情况下。” 第二期开放标签 BLAST 研究对116例 MRD 阳性的费城染色体阴性( Ph-) B 细胞前体 ALL 患者进行了首次或随后的完全血液学缓解后,至少进行了三次强化化疗。在116例患者中,对110例白血病细胞低于5%的患者进行 OS 评估,其中74例接受 BLINYTO 治疗后持续完全缓解( CCR )的造血干细胞移植( HSCT )。 在 EHA 公布的结果显示,在84例达到完全 MRD 反应(没有可测量的 MRD )的患者中,没有达到平均 OS (95% CI :29.5个月-NE ),而那些有可测量 MRD ( n =23;95% CI :3.8-32.3个月)的患者则为14.4个月。在首次完全缓解的 MRD 患者( CR1)中,未完全缓解的 MRD 患者(95% CI :29.5个月-NE )与10.6个月(95% CI :2.7-39.7个月)相比,未完全缓解的 MRD 患者(13; p =0.008)。 “ MRD 的存在是 B 细胞前体 ALL 患者复发的一个强有力的预测因素,” BLAST 研究首席研究员、德国法兰克福成人 ALL 多中心研究小组负责人 Nicola G ö kbuget 医学博士(M.D.)博士说。五年来 BLAST 试验的最后随访结果表明, BLINCYTO 早期完全分子缓解与延长生存期有关。 MRD 阳性患者的安全结果与 BLINCYTO 已知的安全状况一致。 MRD 指的是癌细胞的存在,尽管患者通过常规评估已经完全缓解。1 MRD 的存在被广泛认为是 ALL 最重要的独立预后因素。2-8 MRD 只能通过使用高度敏感的检测方法来测量,这种检测方法可以检测10000个细胞中至少有一个癌细胞敏感的骨髓中的癌细胞,而传统的基于显微镜的评估则是每20个癌细胞中就有一个。1,9,10 BLINCOYTO ,一种双特异性 CD19导向 CD3 T 细胞 BiTE ®(双特异性 T 细胞接合器)分子,是安进(Amgen) BiTE 免疫肿瘤平台首个获批准的分子,也是全球首个获得治疗 MRD 的法规批准的治疗药物。

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