- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: Advances in the treatment of adults with newly diagnosed B-cell acute lymphoblastic leukemia: the role of frontline immunotherapy-based regimens. (Pubmed Central) - Jun 8, 2024 Blinatumomab and inotuzumab ozogamicin (INO) are both active in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and improve outcomes compared with conventional chemotherapy in this setting...This review discusses novel approaches to integrating INO and/or blinatumomab into frontline ALL regimens, including the potential role of chemotherapy-free regimens in some subgroups. The role of MRD monitoring is also discussed, including how this can inform decisions for consolidative allogeneic HSCT or investigational approaches with CD19 CAR T-cells.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Clinical, Observational data, Retrospective data, Review, Clinical Trial,Phase I, Journal: Pneumocystis jirovecii Pneumonia Secondary to Blinatumomab Therapy: A Case Report. (Pubmed Central) - Jun 4, 2024 Despite prophylaxis, PCP infection cannot be ignored during blinatumomab therapy. Therefore, heightened attention is warranted when using blinatumomab therapy.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Darzalex (daratumumab) / J&J, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: Naked antibodies and antibody-drug conjugates: targeted therapy for childhood acute lymphoblastic leukemia. (Pubmed Central) - Jun 4, 2024 These antibodies are currently being tested in patients with newly diagnosed ALL and may lead to major changes in the present paradigm of treatment of pediatric ALL. Unlike the past, lessons may be learned from innovations in adult ALL, in which more drastic changes are piloted that may need to be translated to pediatrics.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Bispecific T-cell engagers in childhood B-acute lymphoblastic leukemia. (Pubmed Central) - Jun 4, 2024 Challenges remain with using BiTE in a broader population although the appeal of now-confirmed reduced toxicity and deeper molecular remissions suggests that this approach will be an essential part of future treatment of childhood B-ALL. Herein, we review some of the pertinent literature covering clinical trials with blinatumomab and address future approaches and combination trials including BiTE.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: SOHO State of the Art Updates and Next Questions | Next Questions: Acute Lymphoblastic Leukemia. (Pubmed Central) - May 30, 2024 In younger patients with Philadelphia chromosome (Ph)-negative ALL, treatment with Hyper-CVAD and blinatumomab +/- inotuzumab has improved the 3-year overall survival (OS) to above 85%...In Ph+ ALL, the chemotherapy-free combinations of blinatumomab and ponatinib (or dasatinib) have become a new standard of care resulting in 3-year OS of 85% to 90%. Because the methotrexate-cytarabine courses were omitted in the nonchemotherapy regimens, central nervous system (CNS) relapses were noted, particularly in patients with a WBC count > 70
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Tecartus (brexucabtagene autoleucel) / Gilead, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: Outcomes of patients aged ?26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials. (Pubmed Central) - May 24, 2024 Future research will be needed to predict which patients are at highest risk to develop MAS after similar T-cell therapies. Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the USA and European Union (EU) for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL; aged ?26
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Review, Journal, Residual disease, Minimal residual disease: The Evolving Landscape of Flowcytometric Minimal Residual Disease Monitoring in B-Cell Precursor Acute Lymphoblastic Leukemia. (Pubmed Central) - May 11, 2024 The introduction of targeted therapies (especially those targeting CD19, such as blinatumomab or CAR-T19) introduces several challenges for flow cytometric MRD analysis, such as the occurrence of CD19-negative relapses...(Semi-)automated MRD assessment, employing machine learning algorithms and clustering tools, shows promise but does not yet allow robust and sensitive automated analysis of MRD. Future directions involve integrating artificial intelligence, further automation, and exploring multicolor spectral flow cytometry to standardize MRD assessment and enhance diagnostic and prognostic robustness of MRD diagnostics in BCP-ALL.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Journal: Evolving Evidence-Based Value Assessment of One-Time Therapies: Tisagenlecleucel as a Case Study. (Pubmed Central) - Apr 29, 2024 Projections at launch of the likely cost effectiveness of tisagenlecleucel appear to have underestimated its ultimate economic value given more recent trial and real-world data. To balance uncertainty in initial valuation with the need to provide access to novel oncology therapies, payers can consider flexible reimbursement policies alongside ongoing assessments as new data emerge.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: T-Cell Engagers-The Structure and Functional Principle and Application in Hematological Malignancies. (Pubmed Central) - Apr 27, 2024 In 2014, the FDA approved blinatumomab, a TCE directed to CD3 and CD19 for treatment of acute lymphoblastic leukemia...TCE-based therapies still have their limitations; however, improving the properties of TCEs, as well as combining TCE-based therapies with other forms of treatment, give hope to find the cures for currently terminal diseases. In this paper, we summarized the technical basis of the TCE technology, its application in hematology, and its current issues and prospects.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Bispecific T cell engager therapy for refractory rheumatoid arthritis. (Pubmed Central) - Apr 27, 2024 Here we treated six patients with multidrug-resistant rheumatoid arthritis (RA) with the CD19xCD3 BiTE blinatumomab under compassionate use...Together, these data suggest the feasibility and potential for BiTEs to treat RA. This approach warrants further exploration on other B-cell-mediated autoimmune diseases.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: SOHO State of the Art Updates and Next Questions: Update on the Approach to Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. (Pubmed Central) - Apr 25, 2024 Achieving NGS MRD negativity can also identify patients who may have durable remissions with a low risk of relapse. Herein, we discuss the current approach to the management of adults with Ph-positive ALL, the role of HSCT, MRD monitoring, and future therapies.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, IO biomarker: A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens. (Pubmed Central) - Apr 10, 2024 Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH?+?ALL...More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH?+?ALL, such as Blinatumomab and Inotuzumab Ozogamicin...These new therapeutic interventions are changing the treatment landscape for PH?+?ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH?+?ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Actemra IV (tocilizumab) / Roche, JW Pharma
Identification of high-grade cytokine release syndrome in retrospective databases () - Apr 9, 2024 - Abstract #AMCP2024AMCP_65; The model performed moderately well in hospital chargemaster and EHR data. These indicators can inform CRS severity in RW data, which is critical for treatment decision-making, espe- cially given the high proportion of patients with codes for unspecified CRS grade.
- |||||||||| Review, Journal: Immune Therapies of B-cell Acute Lymphoblastic Leukaemia in Children and Adults. (Pubmed Central) - Apr 8, 2024
We review data on US Food and Drug Administration (FDA)-approved immune therapies for B-cell ALL in children and adults including blinatumomab, inotuzumab ozogamicin, tisagenlecleucel, and brexucabtagene autoleucel. We also summarize pharmaco-dynamics, pharmaco-kinetics, and pharmaco-economics of these interventions.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
BITEING MULTI-DRUG RESISTANT RHEUMATOID ARTHRITIS WITH CD19-T CELL ENGAGERS (C9) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1363; Eligibility criteria were based on (i) a diagnosis of RA according to the ACR/EULAR 2010 criteria, (ii) evidence for B cell involvement based on positivity of rheumatoid factor (RF) or anti-citrullinated protein antibodies (ACPA) or presence of B cells in the synovial membrane, (iii) active disease with a disease activity score (DAS) 28 over 3.2 units and (iv) treatment resistance to methotrexate and at least three different targeted synthetic (ts) or biologic (b) disease modifying anti-rheumatic drugs (DMARDs). These data demonstrate the principle feasibility to effectively treat B cell mediated autoimmune disease with BiTEs.
- |||||||||| Journal: A pivotal decade for bispecific antibodies? (Pubmed Central) - Mar 15, 2024
Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Enrollment change, Trial withdrawal, Minimal residual disease: DLI-TARGET: Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab (clinicaltrials.gov) - Mar 11, 2024 P2, N=0, Withdrawn, In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium. N=12 --> 0 | Unknown status --> Withdrawn
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
An Interesting Presentation of a Blinatumomab-associated Neurological Event (Colorado Convention Center | Exhibit Hall B-E) - Mar 8, 2024 - Abstract #AAN2024AAN_3507; Ir-AEs include headache, seizures, aphasia, and encephalopathy and are typically managed with infusion interruptions or dexamethasone therapy.Design/Case reportA 39-year-old lady undergoing in-hospital chemotherapy for ALL developed acute onset of global aphasia and right facial droop on day 28 of treatment with blinatumomab prompting activation of a stroke alert...While blinatumomab-induced neurotoxicity was amongst the differentials, due to the focal neurological findings, risk for permanent disability and concern for an acute ischemic stroke, the patient received intravenous therapy with alteplase...An acute neurological change in a patient requires rapid triage and time-sensitive decision making. In patients with cancer who are on immunotherapy with agents such as Blinatumomab, the differentiation of etiologies such as stroke and stroke mimics can be challenging as many of the symptoms of neurologic ir-AEs of Blinatumomab can mimic CVD.
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