- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
Review, Journal: No free rides: management of toxicities of novel immunotherapies in ALL, including financial. (Pubmed Central) - Sep 26, 2019
Blinatumomab, a monoclonal antibody targeting CD19, is associated with cytokine release syndrome (CRS) and neurotoxicity, both of which require prompt recognition and management primarily with corticosteroids...Tocilizumab, an interleukin-6 receptor blocker, is used to treat severe CRS from CAR-T, whereas corticosteroids remain the mainstay for neurotoxicity management. Although effective, these drugs carry a high price tag, and we review the available data on cost-effectiveness of these agents, keeping in mind that median follow-up on most of these studies is limited and that long-term data on durability of response remain to be seen.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date: Observational Study of Blinatumomab (clinicaltrials.gov) - Sep 26, 2019
P=N/A, N=360, Recruiting,
Although effective, these drugs carry a high price tag, and we review the available data on cost-effectiveness of these agents, keeping in mind that median follow-up on most of these studies is limited and that long-term data on durability of response remain to be seen. Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Engineering IgG-Like Bispecific Antibodies-An Overview. (Pubmed Central) - Sep 25, 2019
In addition, Emicizumab, which is a bispecific antibody targeting clotting factors IXa and X, was recently granted market approval by the FDA in 2017 for the treatment of hemophilia A. However, the generation of these next generation therapeutics is challenging and requires tremendous engineering efforts as two distinct paratopes need to be combined from two different heavy and light chains. This mini review summarizes technologies, which enable the generation of antibodies with dual specificities.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, Journal: Current and future role of bispecific T-cell engagers in pediatric acute lymphoblastic leukemia. (Pubmed Central) - Sep 20, 2019
Future research is rapidly progressing on several aspects, including the use of blinatumomab in first-line protocols, identification of factors predicting response, use of combinatorial approaches and bioengineering of new molecules with dual specificity or increased potency, stability and half-life. The results of these studies, expected to be available in the next future, will provide further advancement in the development of effective, impactful, targeted immunotherapy for treatment of childhood BCP-ALL, with the concrete potential to revolutionize the clinical practice.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Tasigna (nilotinib) / Novartis, Inhibikase
Drug-Induced Hemolysis Masquerading As Acute Hemolytic Transfusion Reactions: A Case Report (Exhibit Hall 2-3 - Henry B. Gonzalez Convention Center) - Sep 20, 2019 - Abstract #AABB2019AABB_732;
After discontinuing these drugs she was able to tolerate transfusion without evidence of hemolysis. Drug-induced hemolysis is a rare event that occurs in temporal relation to drug administration, which in this case coincided with transfusion.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Minimal residual disease: Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT) (clinicaltrials.gov) - Sep 15, 2019
P2, N=90, Active, not recruiting,
We conclude that CB-CIKs, combined with bispecific T-cell-engaging antibodies, offer a novel, effective treatment strategy for leukemia. Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Sep 2019 | Trial primary completion date: Mar 2025 --> Sep 2019
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
COBRA: A novel conditionally active bispecific antibody that regresses established solid tumors in mice (Prince George's Exhibition Halls AB) - Sep 15, 2019 - Abstract #SITC2019SITC_120;
We further demonstrate that administration of MVC-101 in mice with established xenografts results in protease cleavage dependent, T-cell mediated tumor regressions in multiple tumor models. Finally, MVC-101 has an extended half-life in vivo upon administration, and rapid clearance post proteolytic activation, resulting in an improved safety profile over conventional T-cell redirected bispecifics.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, Journal, PD(L)-1 Biomarker, IO Biomarker: Clinical Experience with Bispecific T Cell Engagers. (Pubmed Central) - Sep 13, 2019
Blinatumomab is a compound with specificity for the pan-B cell marker CD19...Besides, an upregulation of regulatory T cells and inhibitory molecules like PD-1/PD-L1 may have a role as the loss of target by several mechanisms. The future will show whether the use of bispecifics in ALL can change the standard treatment algorithms and whether bispecific T cell engagers will also be successfully used in other malignant entities.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial initiation date: Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL (clinicaltrials.gov) - Sep 5, 2019
P1, N=10, Not yet recruiting,
This case should encourage routine clinical use of molecular data to individualize therapies targeting the overexpressed pathways responsible for leukemic cell proliferation, as a means to overcome chemoresistance. Initiation date: Jul 2019 --> Dec 2019
- |||||||||| Jakafi oral (ruxolitinib) / Novartis, Incyte
Review, Journal: Infections associated with immunotherapeutic and molecular targeted agents in hematology and oncology. A position paper by the European Conference on Infections in Leukemia (ECIL). (Pubmed Central) - Aug 11, 2019
Hematologists, infectious disease specialists, stem cell transplant experts, pulmonologists and radiologists have met within the framework of the European Conference on Infections in Leukemia (ECIL) to provide a critical state-of-the-art on infectious complications associated with immunotherapeutic and molecular targeted agents used in clinical routine. For brentuximab vedotin, blinatumomab, CTLA4- and PD-1/PD-L1-inhibitors as well as for ibrutinib, idelalisib, HDAC inhibitors, mTOR inhibitors, ruxolitinib, and venetoclax, a detailed review of data available until August 2018 has been conducted, and specific recommendations for prophylaxis, diagnostic and differential diagnostic procedures as well as for clinical management have been developed.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Blinatumomab-Induced Hepatic Sinusoidal Obstruction Syndrome (Exhibit Halls 3 and 4 (Street Level)) - Aug 8, 2019 - Abstract #ACG2019ACG_1132;
Moreover, even though hepatotoxicity in the setting of blinatumomab has been documented, the mechanism of liver injury remains unknown. Further studies can explore whether SOS could relate directly to the method of liver injury in the setting of blinatumomab.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
USE OF BLINATUMOMAB FOR RELAPSE THERAPY OF B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (Poster Area) - Aug 7, 2019 - Abstract #SIOP2019SIOP_1334;
Further studies can explore whether SOS could relate directly to the method of liver injury in the setting of blinatumomab. Blinatumomab is well tolerated agent that can induce MRD remission in pediatric patients with relapsed B-precursor acute lymphoblastic leukemia and facilitate subsequent HSCT.
- |||||||||| Qarziba (dinutuximab beta) / EUSA Pharma, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
HOW WE IMPLEMENTED IMMUNOTHERAPY IN NURSING CARE IN BRATISLAVA 2018 (Poster Area) - Aug 7, 2019 - Abstract #SIOP2019SIOP_184;
In some countries, like we are, there is not easy to have every possibility which our world is providing to children with cancer. Even we have informations, the process of establishment for new therapy is hard to succeed in the health care system, also from financial side.
- |||||||||| Jakafi oral (ruxolitinib) / Novartis, Incyte
Journal: Therapy of Relapsed/Refractory Acute Lymphoblastic Leukemia Today and Tomorrow. (Pubmed Central) - Aug 7, 2019
Ponatinib and other new generation tyrosine kinase inhibitors allow dose reduction of intensive cytostatic regimens in Ph-positive ALL patients and slowly start to overshadow the importance of allogeneic hematopoietic cell transplants...Ruxolitinib, mTOR inhibitors, bortezomib, and other drugs for targeted treatment of ALL are currently being evaluated in clinical trials...1. 2019.
- |||||||||| ibrutinib / Generic mfg.
Journal, IO biomarker: A CD19/CD3 bispecific antibody for effective immunotherapy of chronic lymphocytic leukemia in the ibrutinib era. (Pubmed Central) - Jul 7, 2019
CD19/CD3-scFv-Fc also demonstrated potent activity against CLL cells from patients with acquired ibrutinib-resistance harboring BTK and/or PLCG2 mutations in vitro and in vivo using patient-derived xenograft models. Taken together, these data support investigation of CD19/CD3 bsAbs and other T cell-recruiting bsAbs as immunotherapies for CLL, especially in combination with ibrutinib or as rescue therapy in ibrutinib-resistant disease.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Cancer therapy using bispecific antibodies (Pubmed Central) - Jul 6, 2019
...Blinatumomab, a bispecific T-cell engager (BiTE) that lacks the Fc portion, recognizes CD19 on B tumor cells and CD3 on T cells and induces the T cell-mediated killing of the B tumor cells...Various bispecific antibodies have been developed, including BiTEs that target surface molecules on myeloma cells or intracellular antigens presented on the major histocompatibility complex and Fc portion-containing bispecific antibodies that have a potent T cell-activating capacity and a long half-life. These efforts could lead to the development of potent, off-the-shelf bispecific antibodies for the treatment of a broad array of hematological malignancies.
- |||||||||| Darzalex IV (daratumumab) / J&J, Rituxan (rituximab) / Roche, Biogen
Review, Journal: Should immunologic strategies be incorporated into frontline ALL therapy? (Pubmed Central) - Jun 22, 2019
In contrast, antibody targeting of CD19 and CD22 with blinatumomab and inotuzumab ozogamicin, respectively, has had remarkable single-agent activity in the relapsed setting...The goal of these studies is to improve event-free survival and overall survival by using these approaches in the frontline to eradicate minimal residual disease and, particularly in older adults with ALL, to reduce treatment-related toxicity by limiting the exposure to traditional multi-agent chemotherapy with its attendant toxicities. This review focuses on new immunotherapeutic treatment options and strategies for frontline treatment, including a brief discussion of the use of true immunotherapy, chimeric antigen receptor T-cells, for relapsed B-cell ALL, the potential for targeting CD38 in T-cell ALL, and how these approaches are facilitating the next steps to improve survival for adult patients with ALL.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Roche
Trial primary completion date: BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation (clinicaltrials.gov) - Jun 20, 2019
P2, N=35, Not yet recruiting,
This review focuses on new immunotherapeutic treatment options and strategies for frontline treatment, including a brief discussion of the use of true immunotherapy, chimeric antigen receptor T-cells, for relapsed B-cell ALL, the potential for targeting CD38 in T-cell ALL, and how these approaches are facilitating the next steps to improve survival for adult patients with ALL. Trial primary completion date: Mar 2021 --> Jun 2021
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Review, Journal: Novel monoclonal antibody-based treatment strategies in adults with acute lymphoblastic leukemia. (Pubmed Central) - Jun 18, 2019
Several new agents are also in development that use novel constructs or target alternative surface epitopes such as CD123, CD25, and CD38. Herein, we review the role of monoclonal antibodies in adult ALL and summarize the current and future approaches in ALL, including novel combination therapies and the possibility of early incorporation of these agents into treatment regimens.
- |||||||||| bortezomib / J&J, generics, dexamethasone / generics, doxorubicin hydrochloride / generics
Clinical, Journal: A Bortezomib-Based Protocol Induces a High Rate of Complete Remission with Minor Toxicity in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia. (Pubmed Central) - Jun 15, 2019
...In 2012, a protocol combining bortezomib, dexamethasone, asparaginase, doxorubicin, and vincristine administered to children with RR-ALL was published with encouraging results...Of the seven patients achieving complete remission, two patients were referred for allogeneic bone marrow transplantation, two patients were subsequently given blinatumomab, and one patient subsequently received donor lymphocyte infusion followed by blinatumomab...We observed minimal adverse effects, mainly hematological toxicity. We conclude that the bortezomib-based protocol should be evaluated as an effective and well-tolerated treatment option for adult patients either unfit for or failing standard salvage chemotherapy, as a bridge to immunotherapy or allogeneic bone marrow transplantation.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL (clinicaltrials.gov) - Jun 14, 2019
P2/3, N=41, Active, not recruiting,
We conclude that the bortezomib-based protocol should be evaluated as an effective and well-tolerated treatment option for adult patients either unfit for or failing standard salvage chemotherapy, as a bridge to immunotherapy or allogeneic bone marrow transplantation. Recruiting --> Active, not recruiting | N=332 --> 41 | Trial completion date: Nov 2021 --> Mar 2020 | Trial primary completion date: Sep 2021 --> Mar 2020
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