Blincyto (blinatumomab) / Astellas, Amgen 
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 29 Diseases   85 Trials   85 Trials   3645 News 


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  • ||||||||||  Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, dasatinib / Generic mfg.
    [VIRTUAL] Is Less More? Intensive Versus Non-Intensive Approach to Adults with Ph+ ALL () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_93;    
    In order to increase the rate of MRD-negative patients, we designed a front-line chemo-free phase II induction-consolidation trial (D-ALBA, GIMEMA LAL2116, under revision) based on the combination of the second-generation TKI dasatinib with the bispecific monoclonal antibody blinatumomab...On the other hand, several issues are still open and will be discussed during the meeting. Indeed, the role of transplant is still debated, as there are no definitive conclusions on which patients, and after which strategy, should be spared by the procedure; secondly, extramedullary relapses, particularly those of the central nervous system (CNS) are an unmet clinical need; last but not least, the presence of additional lesions, namely copy number aberrations and mutations and their interplay represent an important prognostic factor; in this respect, the optimal therapeutic strategy to overcome them has not yet been defined.
  • ||||||||||  [VIRTUAL] Who Should Receive an Allogeneic Transplant in First Complete Remission? () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_87;    
    P3
    A study by the GRAALL group performed a time-dependent analysis to evaluate the role of allo-HSCT in patients treated with imatinib in combination with chemotherapy within a prospective trial.13 The use of allo-HSCT was associated with significant benefits in LFS...Although it is generally accepted that allo-HSCT remains a standard of care for Ph-positive ALL, it is postulated that the indications may be restricted with the introduction of third generation TKI (ponatinib) in combination with chemotherapy as first-line treatment.14 The role and duration of maintenance with TKI post-transplant remain uncertain...Both strategies were feasible in a prospective trial by a German study group.16 The use of post-transplant TKI was associated with improved outcomes in a retrospective study by the EBMT.17 A recent study by the MD Anderson Cancer Center showed that TKI maintenance post-allo-HSCT resulted in a lower rate of relapse and improved progression-free survival, and suggested that the optimal duration of TKI should be at least 2 years.18 Transplantation in the era of immunotherapy and targeted therapies The introduction of monoclonal antibodies such as inotuzumab and blinatumomab is changing the landscape of therapy for patients with B-cell precursor (BCP) ALL...TBI-based myeloablative conditioning is the preferred transplant in young patients. Funding Supported in part by grants CERCA/Generalitat de Catalunya SGR 2017 288 (GRC), ISCIII (PI19/01828), co-funded by ERDF/ESF, “A way to make Europe”/”Investing in your future”, Fundació La Caixa, and the Josep Carreras Leukemia Research Institute.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] Mini-Hyper-CVD Combinations for Older Adults: Results of Recent Trials and a Glimpse into the Future () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_85;    
    P2
    Grade 3/4 hyperbilirubinemia was frequent (33%), often delayed therapy, and required dose reductions of asparaginase. The largest (n = 268) prospective trial of chemotherapy designed specifically for older adults (modified intensive Berlin-Frankfurt-Munster regimen) was conducted by the German Multicenter ALL (GMALL) cooperative group and reported a CR, early mortality, and 5-year OS rates of 76%, 14%, and 23%, respectively.16 Although certainly there have been incremental improvements in outcomes with the addition of rituximab to chemotherapy in CD20+ B-ALL17, 18 and increasing use of transplantant,19, 20 more effective and safer treatments are needed for older adults with Ph-negative B-ALL for whom there is no standard of care.
  • ||||||||||  [VIRTUAL] How I Approach the Patient Who Has MRD or Relapse After Transplant () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_48;    
    If CART is unavailable or the patient is not an appropriate candidate, inotuzumab and blinatumomab are both excellent options...In select patients, ponatinib alone or as combination therapy may lead to long-term disease control and survival without additional interventions...If a trial is unavailable, nelarabine or chemotherapy combinations can be considered...Close monitoring of MRD after HCT is recommended, and allows for early detection of impending relapse. Choice of therapeutic intervention for either MRD or overt disease detected post-HCT is influenced by disease and patient characteristics, available clinical trials, and opportunities for additional, potentially definitive cellular therapy interventions.
  • ||||||||||  [VIRTUAL] How the COG is Approaching the High-Risk Patient with ALL: Incorporation of Immunotherapy into Frontline Treatment () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_6;    
    P2, P3
    As a result, attention is being shifted toward novel approaches, including several immune-based therapies such as blinatumomab, inotuzumab ozogamicin, and tisagenlecleucel...Similar to the efforts in SR disease, recent attempts to further intensify treatment have not improved outcomes, as neither an additional delayed intensification phase, the use of triple intrathecal therapy rather than single-agent methotrexate, nor the incorporation of clofarabine/cyclophosphamide/etoposide proved beneficial when studied in newly diagnosed patients.12, 13, 14, 15, 16 Inotuzumab ozogamicin (InO) is an antibody-drug conjugate (ADC) consisting of a CD22-targeted humanized immunoglobulin type G antibody linked to N-Ac-γ-calicheamicin dimethylhydrazide (DMH) that has proven quite effective in the R/R setting.17, 18 In a pivotal phase 3 trial in adults with R/R B-ALL, those randomized to InO had a superior complete response (CR/CRi) rate of 73.8% compared to 30.9% (P < 0.0001) in those treated with best-available chemotherapy, and those in CR with InO were significantly more likely to have MRD < 0.01% (78.4% vs. 28.1%, P < 0.001).19 In a retrospective analysis of outcomes for 51 pediatric patients with R/R B-ALL treated with InO via a compassionate access program, the CR/CRi rate for those patients with overt marrow disease (n = 42) was 67%, of whom 71% had MRD < 0.01%.20 A European phase I trial for pediatric patients reported an overall response (OR) rate of 80%, 79% of whom had MRD < 0.01%,21 and a recent COG phase 2 single agent study (AALL1621) of InO for children with multiply R/R B-ALL demonstrated a CR/CRi rate of 58.3% (95% CI 43.2–72.4%) in 48 patients.22 Of those with MRD reported (n = 26), 65.4% had MRD < 0.01%...Novel immunotherapies with proven efficacy in the R/R setting are now being studied by COG in newly diagnosed patients who are carefully risk-stratified. If successful, these trials could lead to a paradigm shift in our approach to patients newly diagnosed with B-ALL.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal, IO biomarker:  Navigating the nexus of MRD and novel agents in ALL. (Pubmed Central) -  Jul 10, 2020   
    Other new strategies include the incorporation of tyrosine kinase inhibitor-based therapy for patients with Philadelphia chromosome-like ALL and the use of DOT inhibitors and bcl-2/bcl-xl inhibitors in R/R disease. These innovations promise to improve management and outcome in this disease.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Clinical, Review, Journal:  Recent Advances in Adult Acute Lymphoblastic Leukemia. (Pubmed Central) -  Jul 7, 2020   
    Blinatumomab, inotuzumab ozogamicin, and chimeric antigen receptor (CAR) T cells are better options than chemotherapy alone for the treatment of relapsed or refractory ALL...Development of monoclonal antibodies, CAR T, and potent TKI has improved the outcome of ALL. Advances in our understanding of ALL biology are expected to bring new therapeutic strategies in the upcoming years.
  • ||||||||||  dexamethasone / Generic mfg., Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] IS IT WORTH FIGHTING TOGETHER FOR AN INDIVIDUAL ACCESS TO A MEDICINE WITH A NON REIMBURSEMENT DECISION? YES IT IS! (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4787;    
    Overcoming the difficulties to access non-reimbursed orphan drugs requires a team effort, in particular, for therapies with a challenging safety profile where nursing surveillance and care is critical to identify ADR. Our case also suggests that blinatumomab may offer patients with refractory B-ALL a bridge allogeneic transplantation and an opportunity for cure.
  • ||||||||||  dexamethasone / Generic mfg., Blincyto (blinatumomab) / Astellas, Amgen
    [VIRTUAL] IS IT WORTH FIGHTING TOGETHER FOR AN INDIVIDUAL ACCESS TO A MEDICINE WITH A NON REIMBURSEMENT DECISION? YES IT IS! (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4786;    
    Overcoming the difficulties to access non-reimbursed orphan drugs requires a team effort, in particular, for therapies with a challenging safety profile where nursing surveillance and care is critical to identify ADR. Our case also suggests that blinatumomab may offer patients with refractory B-ALL a bridge allogeneic transplantation and an opportunity for cure.
  • ||||||||||  [VIRTUAL] PERSISTENT MIXED CHIMERISM WITHOUT RELAPSE IN CHILDREN AFTER HSCT FOR HEMATOLOGIC MALIGNANCY (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4312;    
    Further study is needed to determine what factors can predict which patients with mixed chimerism will remain in remission in order to avoid the morbidity associated with DLI. Notably, the two patients who had distinction of their cells had mixed chimerism of their myeloid compartment, which may have allowed them to maintain suppression of their leukemia with a combination of NK and T lymphocytes.
  • ||||||||||  [VIRTUAL] PERSISTENT MIXED CHIMERISM WITHOUT RELAPSE IN CHILDREN AFTER HSCT FOR HEMATOLOGIC MALIGNANCY (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4311;    
    Further study is needed to determine what factors can predict which patients with mixed chimerism will remain in remission in order to avoid the morbidity associated with DLI. Notably, the two patients who had distinction of their cells had mixed chimerism of their myeloid compartment, which may have allowed them to maintain suppression of their leukemia with a combination of NK and T lymphocytes.
  • ||||||||||  [VIRTUAL] PERSISTENT MIXED CHIMERISM WITHOUT RELAPSE IN CHILDREN AFTER HSCT FOR HEMATOLOGIC MALIGNANCY (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4310;    
    Further study is needed to determine what factors can predict which patients with mixed chimerism will remain in remission in order to avoid the morbidity associated with DLI. Notably, the two patients who had distinction of their cells had mixed chimerism of their myeloid compartment, which may have allowed them to maintain suppression of their leukemia with a combination of NK and T lymphocytes.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] TARGETED AND IMMUNOCHEMOTHERAPY IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4159;    
    P1/2
    Therapy with nivolumab, inotuzumab ozogamicin or blinatumomab-based regimens may lead to an objective response in patients with r/r NHL. However, due to the short duration of the response, consolidation with allo-HSCT is needed.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] TARGETED AND IMMUNOCHEMOTHERAPY IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4158;    
    P1/2
    Therapy with nivolumab, inotuzumab ozogamicin or blinatumomab-based regimens may lead to an objective response in patients with r/r NHL. However, due to the short duration of the response, consolidation with allo-HSCT is needed.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] TARGETED AND IMMUNOCHEMOTHERAPY IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ePoster Area) -  Jul 3, 2020 - Abstract #EBMT2020EBMT_4157;    
    P1/2
    Therapy with nivolumab, inotuzumab ozogamicin or blinatumomab-based regimens may lead to an objective response in patients with r/r NHL. However, due to the short duration of the response, consolidation with allo-HSCT is needed.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Review, Journal:  Bispecific Antibodies in Hematologic Malignancies: When, to Whom, and How Should Be Best Used? (Pubmed Central) -  Jun 26, 2020   
    Currently, the only bispecific antibody (bsAb) approved for its use in hematologic malignancies is blinatumomab. However, multiple trials are under development not only to explore blinatumomab's clinical activity in other neoplasia, such as lymphoma or multiple myeloma, but also to develop new molecules against different antigens.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
    Journal, Adverse events:  Adhesion of T cells to endothelial cells facilitates blinatumomab-associated neurologic adverse events. (Pubmed Central) -  Jun 25, 2020   
    Evidence for this process includes the coincidence of T-cell redistribution and the early occurrence of most neurologic adverse events; T-cell transmigration through brain microvascular endothelium; detection of T cells, B cells, and blinatumomab in cerebrospinal fluid; blinatumomab-induced T-cell rolling and adhesion to vascular endothelial cells in vitro; and the ability of anti-adhesive agents to interfere with blinatumomab-induced interactions between T cells and vascular endothelial cells in vitro and in patients. Based on these observations, we propose a model that could be the basis of mitigation strategies for neurologic adverse events associated with blinatumomab treatment and other T-cell therapies.
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Enrollment open:  A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (clinicaltrials.gov) -  Jun 22, 2020   
    P3,  N=6430, Recruiting, 
    In our small cohort of patients over 70 years, blinatumomab was safe initial therapy and produced a high response rate. Not yet recruiting --> Recruiting