Blincyto (blinatumomab) / Astellas, Amgen 
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 29 Diseases   78 Trials   78 Trials   3560 News 


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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Retrospective data, Journal, Real-world evidence:  Blinatumomab for treating pediatric B-lineage acute lymphoblastic leukemia: A retrospective real-world study. (Pubmed Central) -  Nov 16, 2022   
    In all 23 patients, increased T-cell and low B-cell counts (<10/μl) were detected during blinatumomab therapy. These encouraging results suggest blinatumomab in pediatric B-ALL patients with MRD or chemotherapy-related toxicities is effective and safe in the short run, although long-term follow-up is still needed.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal, Residual disease, IO biomarker, Minimal residual disease:  Reliable Flow-Cytometric Approach for Minimal Residual Disease Monitoring in Patients with B-Cell Precursor Acute Lymphoblastic Leukemia after CD19-Targeted Therapy. (Pubmed Central) -  Nov 16, 2022   
    The development of the approach, which was adapted for the case of possible CD19 loss, was based on the additional B-lineage marker expression data obtained from a study of primary BCP-ALL patients, an analysis of the immunophenotypic changes that occur during blinatumomab or CAR-T therapy, and an analysis of very early CD19-negative normal BCPs...Qualitative concordance rates of 82.8% and 89.8% were obtained for NGS-MRD and FGT-MRD results, respectively. We have developed a sensitive and reliable approach that allows MFC-MRD monitoring after CD19-directed treatment, even in the case of possible CD19 loss.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Preclinical, Journal, IO biomarker:  The establishment and application of CD3E humanized mice in immunotherapy. (Pubmed Central) -  Nov 15, 2022   
    In contrast, Bispecific antibody blinatumomab inhibited tumor growth significantly. Thus, the CD3E humanized mice provided an adequate animal model for evaluating the efficacy and safety of CD3E antibody drugs.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Darzalex (daratumumab) / J&J, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Utility of High-Throughput Sequencing of Immunoglobulin Genes for MRD in Lymphoid Malignancy in the Context of Current Immunotherapeutics (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6656;    
    Conclusion In this cohort of patients with diverse lymphoid malignancy, HTS-Ig-MRD demonstrated superior sensitivity and analytical performance to detect MRD when compared to MFC which was particularly pronounced in patients receiving antigen-directed therapies that potentially interfere with MFC assessment. These data support the utility of this approach in the current expanding landscape of cellular and immunotherapies.
  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Outcomes Post-Allogeneic Hematopoietic Cell Transplantation Relapse in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6576;    
    Recent advancements in transplantation techniques, the increasing use of tyrosine kinase inhibitor (TKI) maintenance therapy, and novel therapeutics, such as blinatumomab (B), inotuzumab ozogamicin (InO), and chimeric antigen receptor (CAR) T-cell therapy, have improved outcomes...Of the 2 (8%) who received CAR T-cells, 1 (50%) achieved CMR as previously mentioned but relapsed and did not respond to 2 additional CAR T infusions and died of ALL, while the other achieved MMR but had molecular progression and subsequently achieved CMR with ponatinib and remained alive after 7.1 months of follow-up...Conclusion Although utilization of novel agents in our cohort was limited, systemic Ph+ ALL relapse post-HCT in the current era remains challenging to manage. Isolated CNS relapses post-HCT may be associated with a more favorable prognosis than systemic relapses.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
    Standard Cytogenetic Risk Stratification Is Not Predictive of CD19 CAR Outcomes and Impact of Disease Burden Varies between Cytogenetic Risk Groups (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6493;    
    Traditional cytogenetic risk categories are not predictive of response to CD19 CAR therapy, as patients with historically high-risk disease classification have comparable outcomes to patients with low-risk or neutral cytogenetics. Distinct CAR-specific predictors such as high burden disease supplant established risk criteria but are also not uniform amongst cytogenetic sub-categories, thereby supporting the need to develop future CAR-specific risk-classification systems.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Efficacy and Safety of CAR T-Cell Therapy Using a Fully Human CD19-Targeted Binder in Adults with Relapsed/Refractory B-ALL (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6483;    
    P1
    Methods Adult R/R B-ALL pts were enrolled between 2018 and 2022 on a phase I study investigating lymphodepletion (LD) with cyclophosphamide 300 mg/m2/d and fludarabine 30 mg/m2/d for 3 days followed by infusion of JCAR021 for R/R B-cell malignancies (NCT03103971)...Thirteen (57%) had received blinatumomab; 12 (52%) had received inotuzumab ozogamicin...All relapse events were CD19+ and occurred after loss of CAR T-cell persistence and B-cell recovery. Additional strategies are needed to prolong in vivo CAR T-cell persistence and improve outcomes of CD19 CAR T-cell therapy for adult R/R B-ALL.
  • ||||||||||  BCL-2 and BCL-XL Antagonists for the Treatment of Relapsed and Refractory Adult Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma. a Campus ALL Real-Life Study (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_5856;    
    This work was supported by AbbVie, trough supply of venetoclax and navitoclax provided within the therapeutic nominal program (Italian DM 7/9/2017)...For BCP-ALL pts, 6 (75%) had received both inotuzumab and blinatumomab, and 1 also CAR-T-cells; in the whole cohort, 17 pts (53%) had already undergone an allo-SCT...Ven and Ven-Navi-based regimens appear tolerable and show preliminary efficacy in this heavily pre-treated and difficult-to-treat population of pts with ALL and LL, with 43% of pts in CR achieving a MRD negativity and 33% undergoing a subsequent allo-SCT. Survival sub-analyses are in progress and the study continues to accrue pts.
  • ||||||||||  Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Inotuzumab Ozogamicin (InO) Combined with UKALL-R3 Modified Chemotherapy in Pediatric Patients with B-Cell Precursor CD22+ Acute Lymphoblastic Leukemia (BCP-ALL) – Results from the ITCC-059 Phase 1B Trial (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_5855;    
    P1/2
    InO (fractionated in 3 doses/cycle, days 1, 8, 15) was combined with vincristine 1.5 mg/m2 (days 3, 10, 17, 24), two blocks (days 1-5 and 15-19) of dexamethasone 20 mg/m2 (in 2 daily doses), and intrathecal (IT) therapy (methotrexate ± steroids and cytarabine as per local practice; days 1 and 8)...Post study therapy data were available for 22 responders; 14 proceeded directly to HSCT and 6 to CAR-T-cell therapy; 1 received blinatumomab and 1 proceeded to maintenance chemotherapy...The ORR seems comparable to the SA cohorts, but the sample size is small. SA InO is randomized against UKALL R3 in the upcoming trial B1931036 for high-risk first relapsed ALL; a phase 2 study in very-high-risk first relapsed ALL is ongoing (ITCC-059).
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    CD22 CAR T Cells Demonstrate Favorable Safety Profile and High Response Rates in Pediatric and Adult B-ALL: Results of a Phase 1b Study (ENMCC - Hall E) -  Nov 4, 2022 - Abstract #ASH2022ASH_5396;    
    The CD22 CAR resulted in high rates of CR and MRD-negativity independent of prior CD19 CAR and/or blinatumomab exposure. CRS was common but reversible, and the incidence and grades of CRS, ICANS and car-HLH were consistent with long-term follow up data from CD22 CAR studies in pediatric populations.6 CD22 CARs thus present a promising option for both pediatric and adult patients with r/r ALL.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    LILRB4 Is a Novel Target for KMT2A Rearranged Acute Leukemia (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_4685;    
    Furthermore, we demonstrate potent anti-leukemia activity of anti-LILRB4 CAR-T cells against LILRB4 expressing KMT2Ar acute leukemia, broadening the application of this cell therapy. This work offers a new treatment strategy for patients with dismal outcomes and will be tested in a Phase I clinical trial for children and adults with LILRB4 expressing acute leukemia.
  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
    A Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy (mini-hyper-CVD) and Ponatinib Followed By Blinatumomab and Ponatinib in Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_4158;    
    Pts received mini-hyper-CVD alternating with methotrexate and cytarabine on cycles 1-4, followed by blinatumomab and ponatinib on cycles 5-8...Pts with CD20+ disease received rituximab on cycles 1-4...Following consolidation, pts received maintenance therapy with 15 cycles of ponatinib plus vincristine/prednisone (maintenance cycles 1-3, 5-7, 9-11, and 13-15) alternating with ponatinib plus blinatumomab (maintenance cycles 4, 8, and 12) followed by ponatinib monotherapy daily for at least 5 years...One pt discontinued ponatinib and switched to dasatinib due to pulmonary embolism that occurred in cycle 2...The 30- and 60-day mortality rates were 0%. Conclusion Sequential combination of low-intensity chemotherapy and ponatinib followed by blinatumomab and ponatinib is highly effective and well tolerated in Ph+ ALL.
  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Consolidation with Allogeneic Hematopoietic Cell Transplant Improved Survival Outcomes of Adults with Relapsed / Refractory Acute Lymphoblastic Leukemia Following Response to Memory-Enriched CD19CAR T Cells (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_2886;    
    P1
    The median number of prior lines of therapy was 3 (range, 1-9); 29 (63%) pts had prior alloHCT, and 29 (63%) and 15 (33%) pts failed blinatumomab and inotuzumab before enrollment, respectively...Of the 19 pts who responded to CAR T cells and did not have alloHCT consolidation, 11 relapsed with a median time of 3.4 months (range, 2.1-10.3) post CAR T cell infusion, 3 pts died in remission, and 5 pts remained alive and in remission at last contact or date of censoring, with a median follow up of 9.7 months (range, 3.3-51.8) including 1 pt who was censored at day 99 post infusion upon initiating ponatinib maintenance... Outcomes of alloHCT consolidation in adults with high-risk r/r ALL after achieving remission with Tn/mem CD19CAR T cells were promising, including for pts receiving their second alloHCT, and transplant led to improved survival outcomes.