Gazyva (obinutuzumab) / Roche, Biogen 
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 23 Diseases   163 Trials   163 Trials   4765 News 


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  • ||||||||||  Review, Journal:  Advances in Lupus Nephritis Pathogenesis: From Bench to Bedside. (Pubmed Central) -  May 14, 2021   
    Accordingly, the formerly induction-maintenance treatment strategy was recently challenged with the exciting results obtained from the trials that evaluated add-on therapy with voclosporin, belimumab, or Obinutuzumab. The scope of this review is to provide an insight into the current knowledge of LN pathogenesis and future therapeutic strategies.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] LENALIDOMIDE-INDUCED EFFECTS ON CELL SURFACE EXPRESSION OF CD19 AND CD20 IN DLBCL CELL LINES AND FUNCTIONAL IMPACT ON ANTIBODY-MEDIATED CYTOTOXICITY () -  May 13, 2021 - Abstract #EHA2021EHA_1569;    
    For ADCP assays, DLBCL target cells were pretreated with 10 µM LEN or dimethyl sulfoxide (DMSO) for 96 h and then incubated with macrophages at an effector to target (E:T) ratio of 2:1 and 10 nM tafasitamab or rituximab (RTX) for 3 h. For ADCC assays, DLBCL target cells were pretreated with 10 µM LEN or DMSO for 72 h and then incubated with NK cells at E:T ratios of 0.3:1 or 1:1 for 2 h in the presence of 1 nM tafasitamab, RTX or obinutuzumab (OBI)...Rates of ADCC and ADCP with CD20 antibodies were reduced in 3/4 of these cell lines, but this was not observed with tafasitamab. These findings suggest that antigen expression levels could have an impact on combination therapies with LEN in certain DLBCL subtypes and support the rationale for combining tafasitamab with LEN, independent of cell of origin.
  • ||||||||||  zoledronic acid / Generic mfg.
    [VIRTUAL] AUDIT OF CHEMOTHERAPY DISRUPTION DUE TO COVID19 PANDEMIC: PERSPECTIVE FROM A UK DISTRICT GENERAL HOSPITAL () -  May 13, 2021 - Abstract #EHA2021EHA_1497;    
    Similarly for lymphoma patients, maintenance immunotherapy with Rituximab (6) and Obinutuzumab (3) were suspended or stopped in all cases...Among these were 2 patients on Ruxolitinib, one on VMP lite and 1 on Zometa without chemotherapy at the time...Whilst these factors become clearer, additional measures within our practice have aimed to ensure safe patient care in this new environment. These included telephonic and video consultations, home delivery of oral chemotherapy and blood monitoring at local GP surgeries to avoid hospital exposures.
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] LEUKEMIA CUTIS IN CHRONIC LYMPHOCYTIC LEUKEMIA: A RETROSPECTIVE STUDY OF THE FRENCH INNOVATIVE LEUKEMIA ORGANIZATION (FILO) () -  May 13, 2021 - Abstract #EHA2021EHA_1267;    
    Thirty-one patients were treated: 13 patients received a fludarabine or bendamustine-based regimen, 5 chlorambucil based, 5 Ibrutinib, 4 polychemotherapy, 1 obinutuzumab, 2 venetoclax and 1 idelalisib...t(14;18) is enriched and we are currently investigating its significance in this atypical clinical presentation of CLL. Our results suggest that CLL patients with cutaneous lesions are not associated with poor prognosis features and they respond well to CLL systemic treatment.
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis
    [VIRTUAL] SYSTOLIC FUNCTION OF THE LEFT VENTRICULAR MYOCARDIAL IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA RECEIVING IBRUTINIB. () -  May 13, 2021 - Abstract #EHA2021EHA_1257;    
    A previously stable patient after 4 injections of obinutuzumab developed heart failure with severe dyspnea at the level of functional class 3, a sharp decrease in EF from 58.1% to 35.2%, dilatation of the LV cavity - the end-diastolic volume increased from 119.7 ml to 165...An increase in the LV cavity in patients with CLL, taking Ib, may be one of the reasons for a decrease in systolic LV myocardial function.The use of Ib with other antineoplastic drugs that affect the systolic function of the myocardium can lead to a sharp drop in the LV ejection fraction and the development of severe heart failure. Probably, in patients taking Ib, the vulnerability of myocardial systolic function and sensitivity to the effects of various agents on cardiomyocytes is formed.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Zarzio (filgrastim biosimilar) / Novartis, Gazyva (obinutuzumab) / Roche, Biogen
    [VIRTUAL] VENETOCLAX-OBINUTUZUMAB MODULATES CLONAL GROWTH: RESULTS OF A POPULATION-BASED MINIMAL RESIDUAL DISEASE MODEL FROM THE RANDOMIZED CLL14 STUDY () -  May 13, 2021 - Abstract #EHA2021EHA_1248;    
    Aims The aim of this report is to provide a population-based exploratory analysis of MRD growth dynamics after stopping Ven-Obi and chlorambucil-Obi (Clb) therapy and to compare growth trajectories between targeted treatment versus chemoimmunotherapy...Conclusion This analysis establishes a robust, population-based model of MRD growth dynamics that allows description of growth trajectories and treatment effects after treatment cessation. In addition to more effective MRD eradication with Ven-Obi, our results demonstrate that MRD growth is modulated more efficiently by BCL2-targeting treatment in contrast to genotoxic chemoimmunotherapy.
  • ||||||||||  Revlimid (lenalidomide) / BMS, Zarzio (filgrastim biosimilar) / Novartis, Opdivo (nivolumab) / Ono Pharma, BMS
    [VIRTUAL] CHARACTERISTICS AND OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WHO RECEIVED ≥3 LINES OF THERAPIES () -  May 13, 2021 - Abstract #EHA2021EHA_1102;    
    Data were abstracted from COTA, a de-identified database of real-world data, derived from the electronic health records of healthcare providers in the United States. Pts were categorized as receiving 1) chemotherapy or chemoimmunotherapy (CT/CIT), 2) targeted therapy (TT) [brentuximab, vedotin, ibrutinib, venetoclax, lenalidomide, obinutuzumab, nivolumab, polatuzumab, and pembrolizumab], 3) chimeric antigen receptor T cells (CAR-T), or 4) salvage therapy consolidated with hematopoietic stem cell transplantation (HSCT). Patient characteristics, response rates, and overall survival (OS) were reported by line of therapy (3L, 4L) for the overall study population and stratified by treatment category. HSCT being a consolidation therapy for pts achieving a complete or partial remission (CR or PR) following salvage treatment, hence; response rates following HSCT were not reported...Table 1: Treatment patterns and complete response rates for 3rd Line and 4th Line pts 3L 4L n (%) CR rate n (%) CR rate CT/CIT 117 (55) 9.4% 66 (52) 7.6% TT 57 (27) 8.8% 44 (34) 15.9% CAR-T 20 (9) 60% 12 (9) 50% HSCT 18 (8) N/A 6 (5) N/A Conclusion Results from this real-world study illustrate that majority of pts treated with 3L CT/CIT or TT, had poor clinical outcomes, which were exacerbated in the 4L setting. Pts who received cell therapy had better clinical outcomes, however, the proportion of pts receiving these treatments is low. Preliminary data suggests that survival outcomes among CAR-T and HSCT pts, are similar in the 3L and 4L settings. Despite various novel treatments, prognosis for pts with R/R DLBCL remains very poor, underscoring the need for more efficacious treatment options.
  • ||||||||||  [VIRTUAL] PROSPECTIVE EVALUATION OF LYMPHOMA RESPONSE TO IMMUNOMODULATORY THERAPY CRITERIA (LYRIC) IN GATA TRIAL FROM THE LYSA GROUP () -  May 13, 2021 - Abstract #EHA2021EHA_1069;    
    P2
    Methods The GATA study is a LYSA sponsored multicenter phase 2 trial (NCT03276468) evaluating the combination of atezolizumab, obinutuzumab and venetoclax in biopsy-confirmed R/R DLBCL and FL patients who failed at least one line of therapy (rituximab and anthracycline containing regimen)...Interestingly, all IRs at C8 were found to be real progressions. Overall, these data are in favor of using the LYRIC classification, but only for early evaluation.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
    [VIRTUAL] VENETOCLAX-OBINUTUZUMAB FOR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA: 4-YEAR FOLLOW-UP ANALYSIS OF THE RANDOMIZED CLL14 STUDY () -  May 13, 2021 - Abstract #EHA2021EHA_524;    
    P3
    Background The CLL14 study showed significant improvement of progression-free survival (PFS) with venetoclax-obinutuzumab (Ven-Obi) as compared to chlorambucil-obinutuzumab (Clb-Obi) in patients (pts) with previously untreated chronic lymphocytic leukemia (CLL) and coexisting conditions...The majority of pts remains without relapse three years after completing Ven-Obi treatment. Although adverse features such as TP53 mutation/deletion were not fully mitigated, fixed-duration Ven-Obi continues to be an effective treatment for all pts with CLL and with coexisting conditions.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen
    [VIRTUAL] OBINUTUZUMAB SHORT-DURATION INFUSION (SDI) IN PREVIOUSLY UNTREATED ADVANCED FOLLICULAR LYMPHOMA: RESULTS FROM THE END OF INDUCTION ANALYSIS OF THE PHASE IV GAZELLE STUDY () -  May 13, 2021 - Abstract #EHA2021EHA_399;    
    P4
    Background Obinutuzumab (G)-chemotherapy (chemo) has demonstrated improved progression-free survival compared with rituximab (R)-chemo in previously untreated advanced follicular lymphoma (FL)...Methods Pts with previously untreated FL who met Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria received G (1000mg) intravenously on Day (D) 1, 8 and 15 of C1, and on D1 thereafter, plus chemo (bendamustine, CHOP or CVP) for 6–8 cycles...No new safety signals were reported and 67.3% of pts achieved a CR. These data suggest that the safety and efficacy profile of G SDI is comparable with the established profile of G in advanced FL.
  • ||||||||||  Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Roche, Biogen
    [VIRTUAL] Immunotactoid Glomerulonephritis in a donor kidney () -  May 12, 2021 - Abstract #BSH2021BSH_438;    
    We suggest when dealing with Immunotactoid Glomerulopa- thy, consider early evaluation for Lymphoproliferative disorder. Correct diagnosis in a timely manner led to the salvage of the trans- plant kidney.
  • ||||||||||  Calquence (acalabrutinib) / AstraZeneca
    [VIRTUAL] Acalabrutinib-related cardiac toxicities in patients with chronic lymphocytic leukaemia: a meta-analysis of randomised controlled trials () -  May 12, 2021 - Abstract #BSH2021BSH_247;    
    Abstract Content: Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia, Acalabrutinib, a second generation and more selective Bruton’s tyrosine kinase inhibitor, was developed to potentiate efficacy while minimizing ibrutinib-associated side effects...Studies compared acalabrutinib + obinutuzumab versus acalabrutinib monotherapy versus obinutuzumab + chlorambucil in ELEVATE TN trial and acalabrutinib versus investigator’s choice chemotherapy (idelalisib + rituximab or bendamustine + rituximab) in ASCEND trial...There was no significant increase in the risk of all grades of hypertension and high-grade cardiac events or AF in the acalabrutinib group. Future prospective studies are necessary to determine the potential risk factors to develop cardiac toxicities in patients with CLL who received acalabrutinib.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zydelig (idelalisib) / Gilead
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  GAUDEALIS: Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma (clinicaltrials.gov) -  May 10, 2021   
    P2,  N=5, Active, not recruiting, 
    Trial primary completion date: Sep 2021 --> May 2021 Recruiting --> Active, not recruiting | N=43 --> 5 | Trial completion date: Oct 2025 --> Apr 2023 | Trial primary completion date: Oct 2021 --> Apr 2021
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Trial primary completion date:  Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov) -  May 10, 2021   
    P2,  N=27, Recruiting, 
    Recruiting --> Active, not recruiting | N=43 --> 5 | Trial completion date: Oct 2025 --> Apr 2023 | Trial primary completion date: Oct 2021 --> Apr 2021 Trial primary completion date: Apr 2021 --> Oct 2021
  • ||||||||||  [VIRTUAL] Towards control of chronic lymphocytic leukemia with targeted agents (Channel 1) -  May 8, 2021 - Abstract #ICML2021ICML_220;    
    Very encouraging results have also been reported recently regarding the combination of venetoclax plus ibrutinib.48,49 Future prospects: We have entered a new era where combinations of targeted agents achieve long-lasting remissions for the majority of CLL patients...CLL17 protocol of the German CLL Study Group Moreover, we need to intensify our effort to understand and neutralize the cellular mechanism of resistance to the new inhibitors. Finally, and most importantly, we need to make sure that these novel therapies will become available to all patients with CLL world-wide.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    [VIRTUAL] High risk follicular lymphoma: treatment options (Channel 1) -  May 8, 2021 - Abstract #ICML2021ICML_78;    
    Chemotherapy platforms have changed in the past decade, as bendamustine combined with rituximab has become commonly utilized frontline strategy in North America and parts of Europe, although there is certainly no one standard treatment...These include patients with high-risk m7-FLIPI scores, patients who experience recurrence within 2 years of R-chemotherapy, patients who experience histologic transformation, and FL patients under the age of 60 at diagnosis. Future research should (a) seek to identify prognostic biomarkers capable of identifying high-risk patients at diagnosis; (b) continue to develop targeted therapies (with predictive biomarkers); (c) test interventions designed to reduce the risk for histologic transformation; and (d) seek to reliably cure FL.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
    Enrollment closed, Trial primary completion date:  Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia (clinicaltrials.gov) -  May 4, 2021   
    P3,  N=720, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Apr 2021 | Trial primary completion date: Feb 2022 --> Apr 2021 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2025 --> May 2021
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen
    Journal:  Noninvasive evaluation of CD20 expression using Cu-labeled F(ab')2 fragments of obinutuzumab in lymphoma. (Pubmed Central) -  Apr 30, 2021   
    Ex vivo immunofluorescent staining verified the differential CD20 expression in the Ramos and CCL-155 tumor models. Conclusions This study demonstrated that Cu-NOTA-F(ab')2-obi had a rapid and sustained tumor uptake in CD20-positive lymphoma with high contrast, which could enable noninvasive evaluation of CD20 levels in the clinic.