Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   162 Trials   162 Trials   4758 News 


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  • ||||||||||  Columvi (glofitamab) / Roche
    Glofitamab Monotherapy in Patients with Non-Hodgkin B-Cell Lymphoma after Failing CAR T-Cell Infusion: Primary Analysis of the Bicar Study, a Phase II Lysa Study (SDCC - Room 6A) -  Nov 3, 2023 - Abstract #ASH2023ASH_5055;    
    Patients and Methods Pts with a biopsy-proven DLBCL (cohort 1) or non-DLBCL (cohort 2), with no metabolic response, progression or in relapse at least one month after CAR T-cell infusion, received obinutuzumab (1000 mg) 3 days before (Day -3, D-3) the first glofitamab dose...Prior CAR T-cell therapy was axi-cel (n=29, 46%), tisa-cel (n= 25, 39.7%), brexu-cel (n=5, 7.9%) or investigational CAR T-cell (n= 4, 6.3%)...Glofitamab demonstrated a significant increase in OS when used in pts in first relapse/progression after CAR T-cells. In this context, glofitamab resulted in deep and durable responses and manageable safety.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    A Multicenter Phase 2 Trial of Zanubrutinib, Obinutuzumab, and Venetoclax (BOVen) in Patients with Treatment-Na (Grand Hyatt - Grand Hall B) -  Nov 3, 2023 - Abstract #ASH2023ASH_4859;    
    P2
    The early PFS and OS estimates with BOVen compare favorably with historical outcomes of chemoimmunotherapy in this high-risk subset of MCL. Based on this data, BOVen emerges as a promising treatment option for TP53 -mutant MCL and, therefore, the study was expanded to include an additional 25 (total 50) TP53- mutant MCL patients.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Calquence (acalabrutinib) / AstraZeneca
    A Window Study of Acalabrutini (Grand Hyatt - Grand Hall B) -  Nov 3, 2023 - Abstract #ASH2023ASH_4856;    
    RDHAOx chemotherapy (rituximab, dexamethasone, cytarabine, oxaliplatin) prior to ASCT provides a complete response (CR) rate of 77% and favourable toxicity compared to many induction regimens (Le Gouill Blood 2017). Furthermore, Obinutuzumab-DHAP yields undetectable minimum residual disease (MRD) in 85% of young MCL patients...Here we report the primary endpoint from the Australasian Leukaemia & Lymphoma Group phase 2 'WAMM' trial exploring a
  • ||||||||||  Determining Clinical Practice Gaps for HCPs in Treating CLL Using CME-Based Surveys (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4673;    
    Continuing educational activities designed to improve the knowledge, competence, and confidence of HCPs in the care of CLL would benefit patients with this disease. A more detailed data analysis of treatment trends and knowledge by geographic location and role on the care team will be presented.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Impact of COVID-19 in Patients with Chronic Lymphocytic Leukemia Treated with Venetoclax: A Possible Role of the Association to Anti-CD20 Antibody? a Multicentre Seifem Study (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4221;    
    The retrospective multicenter study included CLL patients treated since 2017 with venetoclax single agent until progression or toxicity or venetoclax plus anti-CD20 antibody (mainly rituximab as part of VR protocol for 24 months in relapsed/refractory patients or obinutuzumab as part of VO protocol for 12 months in untreated patients)...Prophylaxis with tixagevimab/cilgavimab was administered in less than 20% of the patients...Remdesivir was chosen as treatment in 48.9%, nirmatrelvir/ritonavir in 21.3%...The analysis found over a third of patients infected by SARS-CoV-2, in 57% of the cases the infection was grade 1-2 with a mortality rate of almost 10%, but higher if COVID-19 was of grade 3-4 (18.2%). We confirmed the association of anti-CD20 antibody to venetoclax as a risk factor for SARS-CoV-2 infection and mortality rate in patients with CLL and severe COVID-19.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    Clinical Outcomes with Venetoclax-Based Treatment Regimens in Patients with Chronic Lymphocytic Leukemia (CLL) (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4214;    
    CONCLUSIONS Patients with BTKi-exposed CLL, particularly those with prior disease progression on BTKi, had worse outcomes. Our study identified CK as one of the most important baseline predictors of adverse TFS and OS in the overall cohort of patients, supporting karyotype assessment for prognostication prior to venetoclax treatment.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
    Ibrutinib, Fludarabine, Cyclophosphamide and Obinutuzumab (iFCG) for Firstline Treatment of Patients with CLL with Mutated IGHV and without Del(17p)/TP53 Mutation: Six-Year Follow-up Analyse... (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4205;    
    P2
    Background Patients (pts) with IGHV -mutated ( IGHV -M) CLL have favorable long-term outcomes after receiving first-line FCR (fludarabine, cyclophosphamide and rituximab)...Two pts had clinical progression: one pt had IGHV 3-21; MRD recurred 28 mos after discontinuing ibrutinib, with clinical relapse 59 mos after discontinuing ibrutinib; this pt is now in remission with venetoclax-based therapy; the second pt with clinical relapse had IGHV -unmutated CLL, MRD recurred 24 mos after discontinuing ibrutinib, with clinical relapse 48 mos after discontinuing ibrutinib; this pt has not yet required therapy for relapse...Additionally, these results also appear favorable to the current targeted therapy regimens (such as BTKi, BCL2i+CD20 antibody) for IGHV -M CLL. With the caveat that the role of chemoimmunotherapy in CLL has significantly declined, the iFCG regimen provides for a very high rate of durable remissions among a chemo-sensitive subgroup of pts with CLL.
  • ||||||||||  Columvi (glofitamab) / Roche
    A Phase I/II Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of Glofitamab As Monotherapy and in Combination with R-ICE Chemoimmunotherapy in Children and Young Adults with Rela... (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4026;    
    P1/2
    Background: Although rare, relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) in children, adolescents, and young adults is an area of high unmet need, with 1-year overall survival rates of <30% and complete remission (CR) rates of 27% after treatment with R-ICE (rituximab, ifosfamide, carboplatin, and etoposide) chemoimmunotherapy (Burke et al...Study treatment is administered with a single dose of obinutuzumab pretreatment followed by glofitamab step doses and repeated glofitamab full doses every 21 days as monotherapy or in combination with R-ICE...The first patient was enrolled in November 2022 and the study is ongoing. The study is planned at 23 sites in 9 countries (Europe, Australia, North America, South Korea, and China).
  • ||||||||||  Columvi (glofitamab) / Roche
    GLOBRYTE: A Phase III, Open-Label, Multicenter, Randomized Trial Evaluating Glofitamab Monotherapy in Patients with Relapsed or Refractory Mantle Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4010;    
    The study is planned at 23 sites in 9 countries (Europe, Australia, North America, South Korea, and China). Chimeric antigen receptor (CAR) T-cell therapies, such as brexucabtagene autoleucel, have shown promising outcomes, but alternative systemic therapies are still needed in this pt population...A Phase I/II trial of glofitamab monotherapy with step-up dosing (SUD) and obinutuzumab pretreatment (Gpt; 1000 or 2000mg) to mitigate the risk of cytokine release syndrome (CRS) showed high and durable complete response (CR) rates (73.0%) and manageable, mostly low-grade CRS in heavily pretreated pts with R/R MCL (n=37), most of whom had failed prior BTKi therapy (Phillips et al...Study Design and Methods : The GLOBRYTE study (GO43878; EU CT: 2023-503206-37-00) is a Phase III, open-label, multicenter, randomized, controlled trial that will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (biomarkers) of glofitamab monotherapy in pts with R/R MCL, in comparison with an investigator
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
    Phase I Safety and Preliminary Efficacy of Acalabrutinib, Venetoclax, and Obinutuzumab (AVO) in Patients with Relapsed/Refractory Mantle Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_3989;    
    P1/2
    Conclusions Our results provide preliminary evidence that the triplet combination of Obinutuzumab, pomalidomide, and covalent BTKi is an active regimen in MCL patients with the mutation of TP53, and should be evaluated in a prospective randomized controlled trial. The triple combination of the first-generation Bruton tyrosine kinase inhibitor (BTKi), ibrutinib, the BCL-2 inhibitor, venetoclax, and anti-CD20 monoclonal antibody, obinutuzumab has demonstrated preliminary safety and efficacy in R/R and treatment na
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Predicted Functional Consequences of TP53 Alterations and Prognosis in TP53-Mutated Mantle Cell Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_3962;    
    The impact of TP53 mutation VAF remains unclear, with seemingly opposite effect directions between the two cohorts, though neither finding was significant. As previously described in the comparator cohort, alterations in SMARCA4 are associated with worse PFS in TP53mut MCL, though this was not observed in the BOVEN cohort.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
    Effective Prevention of Steroid-Requiring Chronic Graft-Vs.-Host Disease with B Cell Depletion: A Randomized, Placebo-Controlled Trial (Marriott Marquis - Marriott Grand) -  Nov 3, 2023 - Abstract #ASH2023ASH_3336;    
    Obin is well tolerated and is associated only with transient neutropenia. Further studies may determine whether prolonged B cell depletion may be of greater utility, however this double-blind, placebo-controlled randomized trial supports practice changing cGVHD prophylaxis in tacrolimus-based HSCT.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
    Acalabrutinib  (Grand Hyatt - Seaport Ballroom ABCD) -  Nov 3, 2023 - Abstract #ASH2023ASH_3320;    
    P3
    With a median follow-up of 74.5 mo, the efficacy and safety of A+O and A monotherapy were maintained in pts with TN CLL, including in pts with high-risk genetic features. At 6 years of follow-up, PFS was significantly longer in pts treated with A+O vs A. Median OS was NR in any treatment arm and was significantly longer in pts treated with A+O vs O+Clb.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
    First-Line Venetoclax Combinations in Fit Patients with CLL: 4-Year Follow-up and NGS-Based MRD Analysis from the Phase 3 GAIA/CLL13 Trial (Grand Hyatt - Seaport Ballroom ABCD) -  Nov 3, 2023 - Abstract #ASH2023ASH_3319;    
    Background The primary endpoint analysis of the GAIA trial showed superior progression-free survival (PFS) and undetectable MRD (uMRD) rates for venetoclax-obinutuzumab (GV) and GV + ibrutinib (GIV) compared to chemoimmunotherapy (CIT) (Eichhorst et al., NEJM 2023)...Pts were randomized to CIT (FCR =65 years; BR >65 years), GV, GIV or ven-rituximab (RV)...NGS-based MRD assessment identifies pts with very long PFS and appears to improve prognostication in pts with uMRD <10 -4 by conventional FCM. Unmutated IGHV and bulky disease were independently associated with shorter PFS in pooled GV/GIV.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
    First-Line Fixed-Duration Ibrutinib Plus Venetoclax (Ibr+Ven) Versus Chlorambucil Plus Obinutuzumab (Clb+O): 55-Month Follow-up from the Glow Study (Grand Hyatt - Seaport Ballroom ABCD) -  Nov 3, 2023 - Abstract #ASH2023ASH_3318;    
    P3
    Among patients treated with Ibr+Ven, benefit in PFS was particularly observed in patients with uIGHV who achieved uMRD at EOT+3 and in patients with mIGHV regardless of MRD status at EOT+3. Moreover, Ibr+Ven fixed-duration combination treatment continues to demonstrate an OS advantage versus chemoimmunotherapy in patients with previously untreated CLL.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    Real-World Response Rates across Lines of Therapy Among Patients with Relapsed/Refractory Follicular Lymphoma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2101;    
    Patients with FL who progress to later LOTs have worsening response rates. This analysis included more patients with later LOTs than previously published reports, providing additional insight into response rates as treatment progresses.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
    The Nature of High-Risk Defining Events in Follicular Lymphoma Determines Overall Survival (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2089;    
    Unlike POD24, this study demonstrates disparate clinical outcomes between patients experiencing early progression with persistent FL and those experiencing TFL. Adverse metabolic characteristics on baseline FDG-PET also suggest biological distinction between HRDE subsets.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Obinutuzumab, Lenalidomide and Venetoclax in Patients with Treatment-Na (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2077;    
    P1/2
    Enrolment to phase II is ongoing at 4 Australian sites. This trial is registered at clinicaltrials.gov ( NCT03980171)
  • ||||||||||  Columvi (glofitamab) / Roche
    Molecular Mechanisms Underlying Response and Resistance to Glofitamab (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2035;    
    P1/2
    In agreement with the molecular analysis, T cells from CR patients (collected at baseline and on treatment) displayed a tendency towards higher cytotoxicity, cytokine secretion and T cell activation compared to PD patients upon ex vivo re-stimulation with glofitamab, suggestive of a better functional state of T cells from patients with CR compared to PD. Taken together, our work provides a thorough characterization of peripheral blood immune cells from CR and PD patients treated with glofitamab, and provides evidence that T cells from CR patients maintain a fresher/naive and more functional state compared to PD patients, which display T cells in a more advanced differentiation state with lower functionality.
  • ||||||||||  Imbruvica (ibrutinib) / AbbVie, J&J
    Long-Term Outcomes in Chronic Lymphocytic Leukemia Treated with Ibrutinib: 10-Year Follow-up of a Phase 2 Study (Grand Hall D (Manchester Grand Hyatt San Diego)) -  Nov 3, 2023 - Abstract #ASH2023ASH_1222;    
    P, P2
    Additionally, these results may inform discussions of continuous BTK inhibitor therapy versus fixed-duration venetoclax combinations in frontline therapy of high-risk CLL. In a subset of ibrutinib-treated patients, depth of response increased over multiple years to the point of uMRD suggesting the possibility that such patients might safely discontinue therapy, following paradigms established in patients with chronic myelogenous leukemia.
  • ||||||||||  Optimizing Circulating Tumor DNA Limits of Detection for DLBCL during First Line Therapy (Grand Hyatt - Grand Hall C) -  Nov 3, 2023 - Abstract #ASH2023ASH_1206;    
    While the technical LOD does not affect disease burden assessment before therapy, using more sensitive assays during and after therapy improves disease detection and outcome prediction. Utilizing the most sensitive ctDNA MRD assays in 1L DLBCL therapy will maximize the efficacy of MRD-driven therapeutic strategies and MRD as a surrogate endpoint in future trials.