Blincyto (blinatumomab) / Astellas, Amgen 
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  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Multidisciplinary Provider Insights to Promote Adoption of Bispecific Antibodies to Treat Cancer in the Community (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5740;    
    The survey primarily assessed experiences with blinatumomab, the first FDA-approved bispecific antibody for the treatment of malignancy (Newman & Benani, 2016)...With this survey data, ACCC is positioned to offer this support. Through its education program, ACCC will build on the survey results to develop content and resources that prepare multidisciplinary providers to welcome BsAbs into the community to treat cancer.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Successful Outpatient Administration of Blinatumomab Infusion in Pediatric Patients with Acute Lymphoblastic Leukemia (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5735;    
    Of the 26 total infusions, 24 were successfully completed without significant adverse reactions. Two patients treated for relapsed disease had to discontinue therapy; one experienced neurotoxicity within 72 hours of blinatumomab infusion initiation and the other developed refractory disease and was switched to another protocol.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Blinatumomab for Patients with Richter’s Syndrome: A Multicenter Phase 2 Trial from the Filo Group (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5258;    
    P2
    Considering the whole strategy (including R-CHOP debulking) (n=28), 15 (54%) patients achieved overall response including 11 (39%) CR. Conclusions Our preliminary data suggest that blinatumomab suggests encouraging anti-tumor activity and acceptable toxicity in patients with RS.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Age-Related Clonal Hematopoiesis Is a Precursor for Adult Acute Lymphoblastic Leukemia (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5161;    
    This may reflect the frequent use of antibody-based therapies (i.e. blinatumomab and inotuzumab) at diagnosis (on a clinical trial basis) or relapse in the two centers where these patients were treated. Collectively, these data suggest that ARCH may constitute a fertile soil for acute lymphoblastic leukemogenesis and further studies are warranted to interrogate the dynamic interplay between myeloid and lymphoid compartments of these patients.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Dose Reduced Chemotherapy in Sequence with Blinatumomab for Newly Diagnosed Older Patients with B-Precursor Adult Lymphoblastic Leukemia (ALL): Results of the Ongoing GMALL Bold Trial (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5080;    
    After a 5-d prephase with dexamethasone (dexa) and cyclophosphamide (cyclo) pts receive dexa (10 mg/m 2 d 7-8 and 14-17), vincristine (2 mg d 7 and 14) and idarubicin (10 mg d 7 and 15) together with i.th...Rituximab is given to pts with CD20+ ALL...Consolidation treatment consists of alternating cycles of intermediate-dose methotrexate/ PEG-asparaginase, intermediate-dose cytarabine and reinduction and 3 further cycles of Blina...Age and subtype appeared to have an impact on the outcome with poorer results for older pts and those with pro-B-ALL. Confirmation of the results in a larger, potentially randomized trial and with longer follow-up is warranted.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Iclusig (ponatinib) / Takeda, Otsuka, Incyte
    Venetoclax-Ponatinib for T315I/Compound-Mutated Ph+Acute Lymphoblastic Leukemia (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5076;    
    The outcome of Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) have greatly improved in tyrosine kinase inhibitors (TKIs) era and is just moving to a chemo-free era using dasatinib and blinatumomab (Foà R, N Engl J Med...Moreover, venetoclax had a strong synergistic effect with ponatinib and dexamethasone on inducing apoptosis of primary blast cells and BaF3 cells expressing p190 BCR/ABL with T315I-mutation in vitro , with a combination index of 0.019 when the suppressing rate is 0.05, while the effect was significant decreased when ponatinib was replaced by dasatinib (Figure 1D-F), a prominent change of mitochondrial membrane potential as well as the cleavage of PARP were also observed in triple-combination treatment group (Figure 1G-H)...A clinical trial also using similar VPD regimen for treatment of R/R Ph+ ALL is ongoing now (Short NJ, Am J Hematol . 2021).
  • ||||||||||  Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    A Phase II Study of Inotuzumab Ozogamicin for the Treatment of Measurable Residual Disease-Positive B-Cell Acute Lymphoblastic Leukemia (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3921;    
    Ursodiol prophylaxis was given to all pts...Ten pts (63%) had Ph-positive ALL; 9 pts received concomitant ponatinib, and 1 received dasatinib...Nine (56%) pts had received prior blinatumomab, 3 (19%) pts had undergone prior ASCT, and one (6%) patient had undergone CAR-T...One patient discontinued study treatment due grade 3 veno-occlusive disease after 5 courses of INO. Conclusion : INO is a well-tolerated and effective agent to eradicate MRD in pts with B-cell ALL who have persistent MRD or who experience MRD recurrence.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    “My T Cell”: A Smartphone Application for Guidance of CAR T Logistics and Management of CAR T & BiTE Related Toxicities (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3521;    
    The Bispecific T-cell engager (BiTE) Blinatumomab and CD19-specific Chimeric Antigen Receptor (CAR) T-cell products are approved for the treatment of relapsed and refractory B-cell neoplasms...Health care professionals validated feasibility and in particular appreciated fast and easy assessment of toxicity grading and management. Thus, “myTcell” is a tool that has the potential to improve guideline adherence and accelerate broader and safer application of CARs and BiTEs based immunotherapy.
  • ||||||||||  Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Outcomes of Children and Young Adults with Acute Lymphoblastic Leukaemia Administered Inotuzumab Pre CAR-T Therapy (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_3327;    
    InO prior to CAR T cell therapy was well tolerated despite the cohort being heavily pre-treated except for one patient who developed fatal VOD prior to CAR T cell infusion. InO was given for disease debulking, rather than to achieve MRD negativity and hence majority of the cohort (75%) received only 1 dose of InO in bridging rather than the usual schedule of three doses weekly per cycle.
  • ||||||||||  mirdametinib (PD-0325901) / SpringWorks Therap, BeiGene, Mekinist (trametinib) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
    Modeling Relapsed, Refractory Acute Lymphoblastic Leukemia from a Child with Neurofibromatosis (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_2882;    
    He relapsed three years later off treatment and was refractory to both salvage chemotherapy and blinatumomab...In a 3-day cell death assay, only P2RY8-CRLF2 + NF1 fs demonstrated sensitivity to trametinib (LD 50 P2RY8-CRLF2 = >6.4 µM, NF1 fs = >6.4 µM, P2RY8-CRLF2 + NF1 fs =1.7µM; p 16 µM, NF1 fs = >16 µM, P2RY8-CRLF2 + NF1 fs = 8.3 µM; p < 0.0001) (Figure 2)...An understanding of the genomic complexities that lead to relapse may also inform personalized treatment strategies. While this patient subsequently achieved remission with inotuzomab and underwent successful stem cell transplantation, the sensitivity to MEK inhibitors is an exciting development for neurofibromatosis patients with ALL.
  • ||||||||||  OSE-127 / Servier
    IL7R Targeting Using OSE-127 Shows Robust Anti-Leukemic Activity in B-Cell Precursor Acute Lymphoblastic Leukemia Xenografts (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_2878;    
    Of note, OSE-127 therapy response associated with IL7R expression levels on BCP-ALL cells and no significant downregulation of the IL7R antigen was observed upon OSE-127 treatment. Taken together, our data demonstrate that IL7R-targeting using OSE-127, which has already demonstrated a good safety profile in healthy volunteers, is an efficient approach for BCP-ALL immunotherapy and may be particularly beneficial for patients with high IL7R-expression and/or relapsed/refractory disease after CD19-directed therapy.
  • ||||||||||  T Cell Engaging Bispecific Antibodies Produce Durable Response in Mesothelin-Positive Patient-Derived Xenograft Models of Pediatric AML (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_2843;    
    Antibody single-chain variable region (scFv) sequences derived from amatuximab recognizing MSLN and from either blinatumomab or AMG330 targeting CD3 were used to engineer and express two MSLN/CD3-targeting BsAbs: MSLN AMA -CD3 L2K and MSLN AMA -CD3 AMG respectively...Chemotherapy (DA) consisted of 3 doses of 1.5 mg/kg daunorubicin iv and 5 doses of 50 mg/kg cytarabine ip...Conclusion These data validate the efficacy of MSLN-targeting BsAbs in PDX models with endogenous MSLN expression. Because prior MSLN-directed therapies appeared safe in humans, MSLN-targeting BsAbs could be ideal immunotherapies for MSLN-positive pediatric AML patients.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, AMG 562 / Amgen
    Treatment-Free Intervals during CD19xCD3 BiTE® Construct-Mediated T-Cell Stimulation Induce Functional Reinvigoration and Transcriptional Reprogramming of Exhausted T Cells (GWCC - B216-B217, Level 2) -  Nov 5, 2021 - Abstract #ASH2021ASH_1945;    
    Blinatumomab is a bispecific T-cell engager (BiTE ® ) construct approved for treatment of relapsed/refractory (r/r) B-cell precursor acute lymphoblastic leukemia (BCP-ALL)...Mimicking the clinical application in an in vitro model system, we showed previously that continuous stimulation (CONT) with AMG 562, a half-life extended CD19xCD3 BiTE ® construct, induces T-cell exhaustion, as seen in chronic infections...In future analyses we will correlate RNA expression levels to functional traits using whole genome co-expression network analysis (WGCNA). Thereby we aim to identify gene clusters critical for persistent T-cell function that might serve as targets to improve efficacy of T-cell based immunotherapies.
  • ||||||||||  huCART19 / Novartis, CART22 / University of Pennsylvania
    CART22-65s Co-Administered with huCART19 in Adult Patients with Relapsed or Refractory ALL (GWCC - B401-B402, Level 4) -  Nov 5, 2021 - Abstract #ASH2021ASH_1878;    
    The two different products demonstrated differential expansion and persistence kinetics. Despite prior exposure to CD19- and/or CD22-specific immunotherapies, all evaluable patients achieved CR with uMRD; we continue to monitor CAR T cell persistence and its impact on durability of response.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
    KMT2A Rearrangements Are Associated with Lineage Switch Following CD19 Targeting CAR T-Cell Therapy (GWCC - Hall A1) -  Nov 5, 2021 - Abstract #ASH2021ASH_1567;    
    The presence of a KMT2A r was the biggest risk factor, with 23.7% of these patients experiencing LS. We found that LS can occur very early in a patient’s post CAR T-cell course, and despite a variety of treatment approaches, the outcomes for these patients are dismal.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Neulasta (pegfilgrastim) / Amgen, Kyowa Kirin, Roche
    [VIRTUAL] THE ASSOCIATION OF BLINATUMOMAB (BLINA) AND INOTUZUMAB (INO) CAN INDUCE COMPLETE RESPONSE OF REFRACTORY B (LLA-B) LINEAGE ACUTE LYMPHOID LEUKEMIA AND ALLOW REFRACTORY HEMATOPOIETIC STEM CELL TRANSPLANTATION (TCTH) () -  Oct 27, 2021 - Abstract #HEMO2021HEMO_1589;    
    Fractioned-dose regimens of Ino have the same efficacy but less hepatotoxicity than a single dose regimen. Blina is a bispecific antibody that binds the CD3 of T lymphocytes to cells that express CD19. Blina would have no action, therefore, in severely aplastic or lymphopenic patients, as its action depends on the action of the patient's own normal T lymphocytes. Anti-CD19 and CD22 CAR-T cells (dual CAR-T) are under development, but the sequential use of the two immunotherapeutics is not described in pediatrics. -B completely refractory to chemotherapy, allowing HSCT in complete remission.Mini-Hyper CVD Cycle 1 - Cyclophosphamide 150 mg/m2, 12/12h, 3 days + Dexamethasone 5 mg IV 6/6h (20 mg/day) 14 days, total 32 doses + Vincristine 2 mg/m2, 2 doses. Pegfilgrastim 6 mg, SC, D9, total 1 dose; Inotuzumab 0.6 mg/m2 D2 and 0.3 mg/m2 D8. Methotrexate 12 mg IT D2, Intrathecal Cytarabine 30 mg IT D7. Cycle 2 - Methotrexate 250 mg/m2 D1, Cytarabine 0.5 g/m2 12/12h D2 and D3, total 4 doses; Inotuzumab 0.3 mg/m2 D2 and D8, total 2 doses, Ara-C IT D2 and Mtx-IT D7. Blinatumomab 15 mcg/m2/day in continuous infusion until the beginning of conditioning.Result A 10-year-old child with ALL-B diagnosed in 2017 presented a relapse at the end of the maintenance of the GBTLI-2009 protocol. It has since been completely refractory to UKR3-ALL, FLAG (2 cycles) and one cycle of blinatumomab. The patient was then treated with mini-HyperCVD + Ino, but after two cycles she remained with 28% of blasts that lost CD22 but returned to expressing CD19. She was back on blinatumomab and, despite being intensely aplastic, she developed a cytokine release syndrome with anasarca and fever. On D11 the myelogram blinatumomab and cerebrospinal fluid were in remission. He continued with blinatumomab until D15, the day he started myeloablative conditioning with TBI 1,200 cGy and fludarabine. He received bone marrow from his haploidentical brother and prophylaxis for graft-versus-host disease with cyclosporine and mycophenolate mofetil. He received ursacol, acetylcysteine ​​and heparin as prophylaxis and did not have sinusoidal occlusion syndrome. Had neutrophilic graft on D+28. Due to the aggressiveness of the disease, it has been maintained with blinatumomab and prophylactic infusion of donor lymphocytes (DLI) without GVHD or disease activity, in excellent health condition for 5 months after HSCT.Conclusion Blina and Ino can be used in an appropriate manner sequence providing refractory disease response and HSCT in remission.