Amgen's blinatumomab has been grained a MHRA licence as the first immunotherapy for adult patients with Philadelphia chromosome negative CD19 positive B Cell precursor acute Lymphoblastic Leukemia in the consolidation phase

Amgen的blinatumomab已获得MHRA许可证，作为费城染色体阴性CD19阳性B细胞前体急性淋巴细胞白血病巩固期成年患者的第一种免疫疗法

“B-cell precursor leukaemia acute lymphoblastic leukaemia (B-ALL) is a rare life-threatening blood cancer. Patients treated with standard of care chemotherapy alone in consolidation, can relapse despite initial responses and hence the E1910 trial investigated whether adding blinatumomab to the standard of care chemotherapy regimen could prolong survival and reduce relapse rates.

“B细胞前体白血病急性淋巴细胞白血病（B-ALL）是一种罕见的危及生命的血癌。仅在巩固期接受标准化疗的患者，尽管最初有反应，但仍可能复发，因此E1910试验研究了在标准化疗方案中加用blinatumomab是否可以延长生存期并降低复发率。

The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse,” said Tony Patrikios, Amgen UK & Ireland Medical Director..

巩固期是一个紧张治疗的时期，对患者及其亲人来说可能是一个令人担忧的时期。安进英国和爱尔兰医疗总监托尼·帕特里基奥斯（TonyPatrikios）表示：“这一许可证使我们能够接触到更多需要一线治疗的英国患者，以降低疾病复发的风险。”。。

“B-cell precursor leukaemia acute lymphoblastic leukaemia (B-ALL) is a rare life-threatening blood cancer. Patients treated with standard of care chemotherapy alone in consolidation, can relapse despite initial responses and hence the E1910 trial investigated whether adding blinatumomab to the standard of care chemotherapy regimen could prolong survival and reduce relapse rates.

“B细胞前体白血病急性淋巴细胞白血病（B-ALL）是一种罕见的危及生命的血癌。仅在巩固期接受标准化疗的患者，尽管最初有反应，但仍可能复发，因此E1910试验研究了在标准化疗方案中加用blinatumomab是否可以延长生存期并降低复发率。

The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse,” said Tony Patrikios, Amgen UK & Ireland Medical Director..

巩固期是一个紧张治疗的时期，对患者及其亲人来说可能是一个令人担忧的时期。安进英国和爱尔兰医疗总监托尼·帕特里基奥斯（TonyPatrikios）表示：“这一许可证使我们能够接触到更多需要一线治疗的英国患者，以降低疾病复发的风险。”。。

The extended indication is based on the Phase III E1910 clinical trial, led by ECOG-ACRIN Cancer Research Group. This randomised-controlled trial studied adult patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving post-induction consolidation treatment. “In the E1910 study, blinatumomab added to consolidation chemotherapy, demonstrated significantly improved survival compared to chemotherapy alone in patients who met the threshold of MRD negativity below 10-4,” said Dr Richard Burt, Cancer Research UK Clinician Scientist at Imperial College London and Honorary Haematology Consultant at University College London Hospital.

扩展适应症基于ECOG-ACRIN癌症研究小组领导的III期E1910临床试验。这项随机对照试验研究了接受诱导后巩固治疗的新诊断为费城染色体阴性B-ALL的成年患者。“在E1910研究中，blinatumomab加入巩固化疗，与单独化疗相比，MRD阴性阈值低于10-4的患者的生存率显着提高，”伦敦帝国理工学院癌症研究英国临床医生兼伦敦大学学院医院荣誉血液学顾问Richard Burt博士说。

“This licence could provide a more effective treatment option compared to standard of care chemotherapy alone for minimal residual disease negative adult patients with B-ALL, by reducing likelihood of relapse and improving survival..

“与单独使用标准化疗相比，该许可证可以通过降低复发可能性和提高生存率，为B-ALL微小残留病阴性的成年患者提供更有效的治疗选择。。

Results from the study demonstrated that in adult patients with Philadelphia chromosome negative CD19-positive B-ALL who are MRD negative (threshold below 10-4), blinatumomab added to multiphase consolidation chemotherapy showed improved overall survival (OS, primary endpoint) and relapse free survival (RFS, secondary endpoint) versus consolidation chemotherapy alone.

研究结果表明，在MRD阴性（阈值低于10-4）的费城染色体阴性CD19阳性B-ALL成年患者中，加入多期巩固化疗的blinatumomab显示总生存期（OS，主要终点）和无复发生存期（RFS，次要终点）与单独巩固化疗相比有所改善。

With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the blinatumomab plus chemotherapy arm and 62.5% in the chemotherapy arm, with the hazard ratio for OS of 0.44 (95% confidence interval 0.25 - 0.76) (p=0.003). The 5-year RFS was 77% in the blinatumomab plus chemotherapy arm versus 60.5% in the chemotherapy arm, with a hazard ratio for RFS of 0.53 (95% CI, 0.32 - 0.88)..

中位随访时间为4.5年，blinatumomab加化疗组5年OS为82.4%，化疗组为62.5%，OS风险比为0.44（95%置信区间为0.25-0.76）（p=0.003）。blinatumomab加化疗组的5年RFS为77%，化疗组为60.5%，RFS的风险比为0.53（95%CI，0.32-0.88）。。