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Antibody-Based Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
Blinatumomab (Blincyto™) is a second-line treatment for Philadelphia chromosome–negative relapsed or refractory acute lymphoblastic leukemia. It is a Bispecific T-Cell Engaging (BiTE) fragment antibody that binds to CD19 antigens on blast cells while simultaneously binding to, and activating, T cells via their CD3 receptors, leading to lysis of the cancer cells. Blinatumomab was developed by Amgen as a treatment for hematological cancers originate from B cell lines, and was approved by the FDA in 2014 under their Accelerated Approval Program.
Pediatric Oncology
Published in Pat Price, Karol Sikora, Treatment of Cancer, 2020
Stephen Lowis, Rachel Cox, John Moppett, Helen Rees
Infants commonly possess the 11q23 MLL gene rearrangement within their malignant clone. This partly explains their poor prognosis, which is worsened if they are less than 6 months of age or have a presenting white cell count >300. If all three features are present the EFS is a dismal 16%. Treatment again consists of induction, intensive blocks, and a prolonged maintenance phase, but there is a stronger reliance on cytarabine, to which the leukemic cells are more sensitive, and bone marrow transplant. Studies are ongoing to look at the role of Blinatumomab in this patient population.13
Tumor immunology
Published in Gabriel Virella, Medical Immunology, 2019
With the growing interest and positive clinical results using T-cell therapies in the treatment of cancer, alternative methods have been developed to target tumors using T cells. Blinatumomab is a bispecific monoclonal antibody that is able to bind to T cells (via CD3) and tumor cells (via CD19); it belongs to a class of molecules called bispecific T-cell engagers (BiTEs) (Figure 26.5). Blinatumomab acts as a link between non-tumor-reactive T cells and tumor cells. Once blinatumomab binds T cells via CD3, it activates them; binding to CD19 (a molecule overexpressed in ALL and many lymphomas), blinatumomab brings T cells in close proximity to tumor cells where a cytolytic synapse forms and tumor cells are killed via classical T-cell killing pathways. The advantage of such an approach is that tumor-reactive T cells are not required, and T-cell activation does not require TCR-MHC complex interaction. Blinatumomab is used for the treatment of ALL and is currently being studied for treatments of different types of lymphomas. In addition, additional bispecific T-cell engagers are being developed to target other types of cancer.
Blinatumomab as salvage therapy in patients with relapsed/refractory B-ALL who have failed/progressed after anti-CD19-CAR T therapy
Published in Annals of Medicine, 2023
Yao Qi, Hong Liu, Xin Li, Yin Shi, Juan Mu, Jingyi Li, Ying Wang, Qi Deng
CRS and ICANS are the major complications in Blinatumomab therapy, especially in patients with high tumor load [27,28]. In our study, only one patient (Pt 2) with high tumor load and CNS leukemia was diagnosed with grade 2 of CRS and grade 1 of ICANS during his salvage therapy of Blinatumomab. All this toxicity disappeared quickly, and no CRS or ICANS-related deaths were observed in our study. We monitored changes in IL-6 levels during Blinatumomab therapy to avoid adverse effects associated with higher CRS and ICANS. Although it remains unclear whether Blinatumomab could penetrate the blood-brain barrier [28], it is safe and effective in patients with R/R B-ALL with CNS [29]. In this study, it suggests that efficacy of Blinatumomab in treating CNS leukemia and Blinatumomab might be a potential option for the treatment of CNS leukemia. In our study, Pt 2 with high tumor load and CNS leukemia obtained an MRD-negative response also. Furthermore, the hematological toxicity of Blinatumomab therapy was recovered quickly. In particular, the two patients with rhizopus microspores pneumonia and cryptococcal encephalopathy achieved CR with MRD negativity, and the infection of the patients was also controlled.
Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia
Published in Hematology, 2022
Zheng Shi, Yiqian Zhu, Jing Zhang, Baoan Chen
In a phase 2 study (NCT01466179), 189 adult patients with Ph negative, R/R BCP-ALL were enrolled [43]. Blinatumomab was administered based on a previous dose-evaluating study by continuous intravenous infusion in 6-week cycles. Patients received Blinatumomab for 4 weeks (9 μg/day for the first week in cycle one and 28 μg/day afterwards) and no treatment for 2 weeks [44]. After the first two cycles of treatment, 33% patients achieved a CR (≤5% bone-marrow blasts, platelets >100,000/μL, and absolute neutrophil count >1000/μL) and 10% patients achieved a CRh (≤5% bone-marrow blasts, platelets >50,000/μL, and absolute neutrophil count >500/μL). Median relapse-free survival (RFS, time from remission to relapse, death, or censoring at last date of continuous remission) and median OS were 5.9 months (95%CI: 4.8–8.3) and 6.1 months (95%CI: 4.2–10.1), respectively. Among patients who had CR or CRh within 2 cycles and evaluated MRD status, 82% achieved MRD negativity. And MRD responders showed a significantly improved median RFS (6.9 months (95%CI: 5.5–10.1):2.3 months (95%CI: 1.2 – not estimable)) and median OS (11.5 months (95%CI: 8.5 – not estimable):6.7 months (95%CI: 2.0 – not estimable)) compared with MRD non-responders. Common grade 3 or 4 adverse events (AEs) included 25% febrile neutropenia, 16% neutropenia, and 14% anemia, and treatment-related deaths were few. This study advanced FDA approval of Blinatumomab in treatment of R/R Ph negative B-cell ALL.
Efficacy and safety of blinatumomab in Chinese adults with Ph-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia: A multicenter open-label single-arm China registrational study
Published in Hematology, 2022
Hongsheng Zhou, Qingsong Yin, Jie Jin, Ting Liu, Zhen Cai, Bin Jiang, Dengju Li, Zimin Sun, Yan Li, Yanjuan He, Liping Ma, Sujun Gao, Jianda Hu, Aili He, Xin Du, Daihong Liu, Xiaohong Zhang, Xiaoyan Ke, Junling Zhuang, Yue Han, Xiaoqin Wang, Yuqi Chen, Paul Gordon, Dong Yu, Gerhard Zugmaier, Jianxiang Wang
China is geographically vast, with the world’s largest population. There are differences in the level of economic development and social insurance systems between regions, with different clinical practices, resources, and cultural nuances among hospitals. Collection of data and maintenance of protocol integrity were therefore often challenging and may be a limitation of this trial. In addition, since the administration of blinatumomab requires continuous IV infusion, physicians and nurses needed to be well trained. Careful clinical and nursing management is required to extend real-world use of blinatumomab in China. Finally, MRD measurement could not be performed at any of the validated laboratories in the United States and Europe that performed MRD for our global trials as Chinese regulations do not allow patient samples to be exported outside of China. A laboratory in mainland China was therefore used, which could also be a limitation for this trial.