- |||||||||| 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.
- |||||||||| 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.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Innovative mRNA strategies to encode CD19/CD3 T cell engagers in the treatment of B cell hematological malignancies (Section 3) - Mar 5, 2024 - Abstract #AACR2024AACR_9487;
Blinatumomab, a bispecific CD19/CD3 TCE, has shown remarkable efficacy in treating refractory or relapsed B-cell Acute Lymphoblastic Leukaemia (B-ALL), including cases resistant to conventional chemotherapy, leading to its global approval for B-ALL management...One candidate mRNA demonstrated an optimal "plateau" pharmacokinetic profile, achieving extensive target cell eradication over 20 days with a single low dose of 0.001 mpk in non-human primates.An investigator-initiated clinical study with mRNA encoding CD19/CD3 TCE is underway in relapsed and/or refractory acute lymphoblastic leukemia patients. The preliminary data from the on-going study showed ABO2015 with an acceptable safety profile, and activation of peripheral T cells was observed in one patient with low dose.These findings underscore the significant clinical potential of mRNA-encoded CD19/CD3 TCE in treating B-cell malignancies, heralding a paradigm shift in the clinical application of protein-based T cell engagers.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
A novel long acting pegylated T cell engager targeting CD3 and cd19 with effective tumor killing and no potential CRS risk in CD19+ hematologic malignancies (Section 23) - Mar 5, 2024 - Abstract #AACR2024AACR_5326;
However, Blinatumomab, a bispecific T cell engager of CD3/CD19, has disadvantages in clinical setting due to the adverse pharmacokinetics (PK), which resulted in less than 2 hours of in vivo elimination half-life, neurotoxicity, and cytokine release syndrome...We postulated that the lower CD3 affinity of JY108 most probably resulted in the decoupling of the signaling for activating the gene expression of cytokines from the secretion of the polarized lytic granules by T cells, which resulted in a much milder T cell activation by JY108. Currently, JY108 is a phase I trial candidate and awaits further evaluations.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, navitoclax (ABT 263) / AbbVie
Trial primary completion date: Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov) - Mar 2, 2024
P1/2, N=90, Recruiting,
The novel RACE platform represents a potent as well as safe immuno-oncology strategy, demonstrating significant potential for clinical application. Trial primary completion date: Aug 2024 --> Aug 2025
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date: NCI-2018-01078: Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Mar 2, 2024
P2, N=90, Recruiting,
Trial primary completion date: Aug 2024 --> Aug 2025 Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
202-B - Baby Steps: Updates in the Treatment of Infant Leukemia (Ballroom A) - Feb 27, 2024 - Abstract #HOPA2024HOPA_33;
This breakout session will review appropriate management to arm healthcare professionals to treat these complex patients. Additionally, recently published literature, including upfront blinatumomab, will be discussed along with practical considerations for implementing these changes.Learning Objectives:
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost and cost-effectiveness of immunotherapy in childhood ALL: A systematic review. (Pubmed Central) - Feb 26, 2024
No studies have evaluated blinatumomab or inotuzumab ozogamicin...The cost-effectiveness of tisagenlecleucel was highly dependent on list price and cure rates. This study can inform the use of tisagenlecleucel in pALL.
- |||||||||| Remicade (infliximab) / J&J, Blincyto (blinatumomab) / Astellas, Amgen
Preclinical, Journal, Cytokine release syndrome: Myeloid and dendritic cells enhance therapeutics-induced cytokine release syndrome features in humanized BRGSF-HIS preclinical model. (Pubmed Central) - Feb 26, 2024
BRGSF mice reconstituted with human umbilical cord blood CD34+ cells (BRGSF-CBC) were injected with anti-CD3 antibody (OKT3), anti-CD3/CD19 bispecific T-cell engager Blinatumomab, or VISTA-targeting antibody...Clinical CRS-managing treatment Infliximab efficiently attenuated OKT3-induced toxicity...These data show that BRGSF-CBC mice represent a relevant model for the preclinical assessment of CRS and CRS-managing therapies. They also confirm a significant role of myeloid and dendritic cells in CRS development and exhibit the versatility of this model for therapeutics-induced safety assessment.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, CAR T-Cell Therapy: Leveraging CD19CAR T cells early in the treatment of older patients with B-ALL: are we there yet? (Pubmed Central) - Feb 26, 2024
However, these agents have their own challenges including the limited durability of remission, the need for additional concurrent chemotherapy and the prolonged course of treatment, and limited efficacy in the setting of extramedullary disease. Here, we hypothesize that the incorporation of chimeric antigen receptor (CAR) T cell therapy as a consolidation treatment in older adults with B-cell ALL in their first complete remission is the ideal setting to advance treatment outcomes by reducing treatment toxicity, enhancing remission durability, and expanding the use of this effective therapy in this age population.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
To B or Not to B: Utility of PAX5 in Lineage Assignment of Acute Leukemia (Exhibit Hall; Poster Board Number: 310) - Feb 18, 2024 - Abstract #USCAP2024USCAP_1150;
In urgent cases where CD19 is dim and other markers by flow such as CD79a, CD22 are not uniformly strong, adding PAX5 can "rescue" the leukemia lineage assignment. Recent genome-wide CRISPR screens demonstrate that PAX5 modulates blinatumomab response in B-ALL; possible future directions include studying ways of quantitatively measuring PAX5 expression in these tumors as a predictive marker.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Building a better blinatumomab. (Pubmed Central) - Feb 17, 2024
Notably, the patient continued to maintain molecular remission for 1 No abstract available
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Trial completion date, Trial primary completion date: A041703: Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Feb 15, 2024
P2, N=64, Recruiting,
Trial completion date: Apr 2031 --> Sep 2031 | Trial primary completion date: Jul 2026 --> Dec 2026 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date: Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma (clinicaltrials.gov) - Feb 15, 2024
P1, N=44, Active, not recruiting,
Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025 Trial completion date: Dec 2023 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Mar 2025
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