Blincyto (blinatumomab) / Astellas, Amgen 
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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal:  Blinatumomab: a novel therapy for the treatment of non-Hodgkin's lymphoma. (Pubmed Central) -  Jun 14, 2020   
    Expert Opinion: Although blinatumomab showed impressive results in phase I and II studies for relapsed/refractory DLBCL, its future utility remains to be seen in this clinical setting due to lack of phase III trial and FDA approval of CD19 CART therapy. A new CD19/CD3 and several CD20/CD3 bispecific antibodies with longer half-life and resultant easier mode of administration which can overcome the major barriers of its use in clinical practice are in the pipeline and their role in NHL treatment are actively explored.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal:  Indirect Treatment Comparison of Inotuzumab Ozogamicin Versus Blinatumomab for Relapsed or Refractory Acute Lymphoblastic Leukemia. (Pubmed Central) -  Jun 12, 2020   
    It was not possible to fully adjust for all treatment-effect modifiers, and the similarity in chemotherapy regimens used in the SoC comparator arms of the INO-VATE-ALL and TOWER studies is worthy of further exploration. Both studies, however, used chemotherapy regimens that have a low response rate; therefore, no significant differences in efficacy outcomes are expected between SoC arms.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal:  Moving immunotherapy into the front line in ALL. (Pubmed Central) -  Jun 11, 2020   
    The past several years have yielded successful uses across a variety of malignancies, and enthusiasm continues to rise for applying these therapies more broadly. Herein we discuss current approaches incorporating the bispecific T-cell engager blinatumomab, the antibody-drug conjugate inotuzumab ozogamicin (InO), and CD19-directed chimeric antigen receptor T cells in children with relapsed/refractory B-cell ALL and discuss the potential for using these immunotherapies in the treatment of newly diagnosed children.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal, IO Biomarker:  Mechanisms of and approaches to overcoming resistance to immunotherapy. (Pubmed Central) -  Jun 11, 2020   
    Preclinical work is focusing on additional engineering of CAR T cells to overcome these inherent immune deficits. Last, with improved knowledge of which patients are likely to benefit from immunotherapy as definitive treatment, those patients who are predicted to develop resistance may be prospectively recommended to undergo a consolidative hematopoietic cell transplant to lessen the recurrence risk.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] Bispecific Antibodies Catching Fire () -  Jun 9, 2020 - Abstract #BIO2020BIO_52;    
    Since the first FDA approved bispecific antibody Blincyto hit the market in 2015, a wave of new bispecific technology platforms has emerged with promises to improve upon early generation approaches aimed at engaging two different drug targets with a single monoclonal antibody...With claims of simpler and more predictable manufacturing compared to the CAR-T immunotherapies and improvements in dose and administration compared to early generation bispecific modalities, 2020 promises to be a big year for bispecific antibodies. Companies on the crest of this wave detail their predictions on the emergence of bispecific antibodies, and their potential to open up new biology in cancer and other diseases.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date:  A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance (clinicaltrials.gov) -  Jun 1, 2020   
    P1/2,  N=64, Recruiting, 
    These data should be interpreted with caution because the current study was not designed to prospectively assess survival outcomes associated with HSCT after blinatumomab. Phase classification: P1 --> P1/2 | N=12 --> 64 | Trial completion date: May 2020 --> Jun 2025 | Trial primary completion date: May 2020 --> Jun 2025
  • ||||||||||  Nailike (olverembatinib) / Ascentage Pharma, Takeda
    Trial primary completion date:  HQP1351CU101: Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (clinicaltrials.gov) -  May 28, 2020   
    P1,  N=30, Recruiting, 
    Phase classification: P1 --> P1/2 | N=12 --> 64 | Trial completion date: May 2020 --> Jun 2025 | Trial primary completion date: May 2020 --> Jun 2025 Trial primary completion date: Jun 2021 --> Dec 2020
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Clinical, Review, Journal, CAR T-Cell Therapy:  Clinical trials of dual-target CAR T cells, donor-derived CAR T cells, and universal CAR T cells for acute lymphoid leukemia. (Pubmed Central) -  May 17, 2020   
    Tisagenlecleucel (kymriah, Novartis) is an autologous CD19-targeted CAR T cell product approved for treatment of R/R B cell ALL and lymphoma...Gene-edited "off-the-shelf" universal CAR T cells are also undergoing active clinical development. This review summarized new clinical trials and latest updates at the 2018 ASH Annual Meeting on CAR T therapy for ALL with a focus on dual-target CAR T and universal CAR T cell trials.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Preclinical, Journal:  Characterization of a Novel Bispecific Antibody That Activates T Cells In Vitro and Slows Tumor Growth In Vivo. (Pubmed Central) -  May 17, 2020   
    Although CD3 T cell redirecting antibodies have been successfully utilized for the treatment of hematological malignancies (blinatumomab), the T cell signaling pathways induced by these molecules are incompletely understood...This is the first study that investigates both in vitro and in vivo murine CD8 T cell function and signaling induced by a CD3xEpCAM antibody having a silent Fc to delineate differences between antigen-independent and antigen-specific T cell activation. These findings expand the understanding of T cell function and signaling induced by CD3 redirection bispecific antibodies and may help to develop more efficacious CD3 redirection therapeutics for cancer treatment, particularly for solid tumors.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    BALB/c-hCD3E transgenic mice to evaluate humanCD3-bispecific antibodies (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_825;    
    It’s worth noting that further knockout of mCd3e in BALB/c-hCD3E mice cause remarkable reduce of splenic T cells, strong tumor inhibition of anti-mCTLA4 was observed in BALB/c-hCD3E but not BALB/c-hCD3E/mCd3e-KO mice, demonstrate that mCD3ε is indispensable for T-cell development and function in BALB/c-hCD3E transgenic mice. Taken together, these findings indicate that BALB/c-hCD3E mice with intact mCd3e is a novel and valuable model to assessing the therapeutic efficacy of TCBs.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, emibetuzumab (LY2875358) / Eli Lilly, onartuzumab (RG3638) / Roche
    T-cell recruitment tumor lysis via a novel c-MET/CD3 bispecific antibody (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_4105;    
    Various kinase inhibitor and monoclonal antibody (e.g. Emibetuzumab and Onartuzumab) have been developed to block the HGF/c-MET interactions, however, those kinase-inhibiting-based therapeutics have shown limited success in clinical trials...An example of this design strategy is the FDA-approved bispecific antibody blinatumomab...Collectively, the novel c-MET/CD3 bispecific antibody can provide immunotherapy for c-MET-overexpressing tumors which conventional antibody or small molecular inhibitor might not. These findings also support the immunotherapeutic effects on combination of T-cell dependent bispecific antibody and immune checkpoint blockade.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Genetic screens identify T cell co-stimulation as a key modifier of the redirected cytotoxicity of bispecific T cell engager (BiTE®) molecules (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_2608;    
    Blinatumomab, an anti-CD19 BiTE® molecule used to treat pre-B-ALL patients, leads to more than 40% complete remission rates...Considering that loss of CD58 is highly prevalent in DLBCL and relapsed Hodgkin lymphoma patients, it could potentially serve as a biomarker to predict response to BiTE®-based therapies. Our study also demonstrates that restoring CD58-CD2 interaction could sensitize cancer cells to BiTE®-mediated killing.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, RG7827 / Roche
    Combination of TYRP1-TCB, a novel T cell bispecific antibody for the treatment of melanoma, with immunomodulatory agents (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_2583;    
    Bispecific antibodies like blinatumomab have been approved for hematologic malignancies but positive benefit in solid tumors has been more challenging to demonstrate...Furthermore, the combination with immunomodulatory agents like FAP-IL2v and FAP-4-1BBL molecules demonstrated enhanced efficacy as compared to the respective single agents. These preclinical data support the clinical evaluation of TYRP1 targeted CD3 bispecific antibody as a single agent and in combination in metastatic relapsed/refractory melanoma patients.
  • ||||||||||  Removab (catumaxomab) / NeoPharm, Trion, Blincyto (blinatumomab) / Astellas, Amgen
    Non-genetic generation of IgG-like immune cell-redirecting antibodies lacking effector function (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_2153;    
    Chemoenzymatic Conjugation of Toxic Payloads to the Globally Conserved NGlycan of Native mAbs Provides Homogeneous and Highly Efficacious Antibody−Drug Conjugates. Bioconj. Chem. 2015, 26, 2233-2242.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Rapid and sensitive determination of cytokine release from cells without the need for sample transfer (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_163;    
    In all cases, a calibration curve of recombinant cytokine enabled straightforward conversion of relative light units (RLU) to concentration of released cytokines. The implementation of this novel detection chemistry will enable rapid “add-and-read” assays for cytokine detection amenable for both low- and high-throughput screening applications.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] EFFICACY AND SAFETY OF BLINATUMOMAB IN ASIAN ADULTS WITH RELAPSED/REFRACTORY B-PRECURSOR ALL () -  May 16, 2020 - Abstract #EHA2020EHA_681;    
    P1b/2, P3
    Grade ≥ 3 events TEAEs of interest included neurologic events (4.5%), cytokine release syndrome (2.3%), cytopenias (6.8%), and infections (20.5%). Conclusion The safety and efficacy of blinatumomab in Asian patients were comparable with previous global studies with similar disease response rates and a favorable safety profile with no new safety signals.
  • ||||||||||  [VIRTUAL] CART19-BE-01: A EUROPEAN ACADEMIC TRIAL ON THE ADMINISTRATION OF ARI-0001 CELLS IN PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AND OTHER CD19+ LYMPHOPROLIFERATIVE DISORDERS () -  May 16, 2020 - Abstract #EHA2020EHA_466;    
    New agents, such as inotuzumab or blinatumomab, have improved the complete response rate in RR ALL, but the progression-free survival (PFS) is shorter than 6 months...A second product (axi-cel) was approved for RR DLBCL...Lymphodepletion chemotherapy comprised fludarabine (90 mg/m2) and cyclophosphamide (900 mg/m2), after which 0.5-5 x106 ARI-0001 cells/kg were infused, initially as a single dose (n=19) and later in 3 fractions (10%, 30% and 60%, n=28) depending on the occurrence (or not) of cytokine release syndrome (CRS)...In February 2020 a marketing authorization application under the Hospital Exemption Rule was submitted to the Spanish Medicines Agency. This is a first example showing how academic and Pharma initiatives can be complementary and synergistic in the best interest of patients.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, fludarabine / Generic mfg., Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    [VIRTUAL] ALLCAR19: UPDATED DATA USING AUTO1, A NOVEL FAST-OFF RATE CD 19 CAR IN RELAPSED /REFRACTORY B-ACUTE LYMPHOBLASTIC LEUKAEMIA () -  May 16, 2020 - Abstract #EHA2020EHA_372;    
    P1
    Study design: subjects 16-65y underwent lymphodepletion with fludarabine (30mg/m2 x3) and cyclophosphamide (60mg/kg x1) followed by split dose CAR T-cell infusion (Day 0: if>/=20% BM blasts, infuse 10 x106 CAR T-cells; if <20% BM blasts, 100 x106 CAR T-cells...The median age was 35.5y (range 18-58), 69% had prior blinatumomab or inotuzumab ozogamicin and 75% had prior HSCT...This preliminary data supports the further development of AUTO1 as a stand-alone treatment in patients with r/r B-ALL. Data from addiitonal patients and more follow up will be presented.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, navitoclax (ABT 263) / AbbVie, Roche
    [VIRTUAL] VENETOCLAX AND NAVITOCLAX IN RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AND LYMPHOBLASTIC LYMPHOMA () -  May 16, 2020 - Abstract #EHA2020EHA_369;    
    P1
    Conclusion Ven+Nav with chemotherapy is well-tolerated, and efficacy is promising in heavily pretreated pts (including those with prior blinatumomab, inotuzumab, or CAR-T) with high rates of CR/CRi/CRp. Clinical follow-up, correlative biomarker analysis, and expansion cohort enrollment to assess discontinuous dosing are underway.
  • ||||||||||  cyclophosphamide intravenous / Generic mfg.
    Relapsed acute lymphoblastic leukaemia diagnosed using femoral head histology () -  May 14, 2020 - Abstract #BSH2020BSH_312;    
    She was treated with FLAG‐IDA, followed by blinatumomab due to ongoing minimal residual disease (MRD) positivity, before undergoing an allogenic transplant...The patient received FLAG‐IDA, inotuzumab and gemtuzumab, following which he was in remission...The patient was re‐treated with nelarabine, cyclophosphamide and etoposide with high‐dose methotrexate...From literature there are only case reports of relapsed ALL presenting this way and the exact number of patients with evidence of disease in the femoral head is unknown. We would recommend as a result of our experience always sending bone specimens for histology in patients with a history of ALL undergoing joint replacement surgery.