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


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  • ||||||||||  FT516 / Fate Therap
    Enrollment open, Combination therapy, Monotherapy, Metastases:  FT516-101: FT516 in Subjects With Advanced Hematologic Malignancies (clinicaltrials.gov) -  Oct 6, 2019   
    P1,  N=72, Recruiting, 
    OBI was not associated with increases in rates of serious adverse events or serious infections. Not yet recruiting --> Recruiting
  • ||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Gazyva (obinutuzumab) / Biogen, Roche
    Antibody modification: is it even better? (Hall A3) -  Sep 30, 2019 - Abstract #DGHO2019DGHO_456;    
    Therefore, strategies in improving these effector functions by Fc-engineering have been evaluated and with obinutuzumab were clinically translated in lymphoma therapy...With the approval of blinatumomab in ALL, especially T cell-engaging bispecific antibodies have regained great attention, but also alternative antibody formats designed to potently activate NK cells via engagement of FcγRIIIa or NKG2D may represent promising agents...With inotuzumab-ozogamicin a prototypic antibody drug conjugate has recently been approved in ALL treatment and a variety of next generation agents entered clinical development...In conclusion, a large panel of antibody engineering strategies have been developed allowing the rational design of next generation antibodies with tailor-made unique effector functions. Established and emerging antibody engineering concepts will be presented and discussed.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Review, Journal, Residual disease, IO Biomarker:  Minimal Residual Disease in Chronic Lymphocytic Leukemia: A New Goal? (Pubmed Central) -  Sep 27, 2019   
    Thus, beside a durable disease control desirable particularly for older patients and/or for those with comorbidities, a MRD-negative complete remission is becoming a realistic prospect for CLL patients in an attempt to obtain a long-lasting eradication and possibly cure of the disease. Here we discuss the standardized and innovative technical approaches for MRD detection in CLL, the clinical impact of MRD monitoring in chemoimmunotherapy and chemo-free trials and the future clinical implications of MRD monitoring in CLL patients outside of clinical trials.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Next Generation Small Molecules in Chronic Lymphocytic Leukemia () -  Sep 26, 2019 - Abstract #SOHO2019SOHO_285;    
    At a dose of 65 mg, 4/6 patients with CLL responded.11Vecabrutinib (formerly SNS-062) is a relatively selective reversible BTK inhibitor which also targets ITK...Loxo-305 is a very selective reversible inhibitor, and CG-806 is a BTK and FLT3 inhibitor...Hopefully these strategies can be tested once the differential efficacy and safety of the reversible inhibitors becomes apparent.Conclusions Reversible inhibitors of BTK represent an exciting therapeutic strategy in CLL and other B cell malignancies. Emerging clinical trial are of great interest to the CLL community, and as well, preclinical data which will help differentiate these agents is of high importance and eagerly anticipated.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    CLL: State of the Art Update () -  Sep 26, 2019 - Abstract #SOHO2019SOHO_284;    
    Notable in both the Alliance and Illuminate studies was a high rate of grade 5 adverse events during the ibrutinib treatment period, at 7% on both ibrutinib arms in the Alliance study (vs 1% for BR) and 10 fatal events in 113 patients on Illuminate (vs 3 events on chlorambucil-obinutuzumab)...The ASCEND trial compared acalabrutinib, a second generation, more specific covalent BTKi, to investigator choice of idelalisib rituximab or BR in relapsed CLL patients...The triple drug regimen, ibrutinib venetoclax obinutuzumab, has been reported by the Ohio State group to have a 67% rate of undetectable MRD among previously untreated patients at the conclusion of 14 months of therapy...What are the mechanisms of resistance to dual BTKi-BCL2i therapy and can we avoid resistance by stopping therapy? These are exciting times in CLL, with ever more emerging data, yet still many more questions than answers as we try to rationally integrate novel therapies into the treatment paradigm.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
    Mechanisms of Resistance in CLL () -  Sep 26, 2019 - Abstract #SOHO2019SOHO_249;    
    Nevertheless, very similar questions arise as for the role of BTK/PLCG2 mutations in ibrutinib resistance given the fact that these mutations are not observed in all relapsing patients and the variant allelic frequencies at the time of relapse can vary considerably and are often less than 10%. The field of investigation of mechanisms of resistance to novel drugs just started and we need to understand more before we can use these notions to modify the way in which we treat our patients with CLL, including those becoming resistant to the novel targeted therapies.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
    Enrollment open:  LEVERAGE: Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Na (clinicaltrials.gov) -  Sep 18, 2019   
    P1/2,  N=61, Recruiting, 
    Trial completion date: Jul 2019 --> Mar 2020 | Trial primary completion date: Jul 2019 --> Mar 2020 Not yet recruiting --> Recruiting
  • ||||||||||  Arzerra (ofatumumab) / Novartis, Genmab, Gazyva (obinutuzumab) / Biogen, Roche, Imbruvica (ibrutinib) / AbbVie, J&J
    Review, Journal:  The Role of Rituximab in Chronic Lymphocytic Leukemia Treatment and the Potential Utility of Biosimilars. (Pubmed Central) -  Sep 14, 2019   
    However, patents for many biologics, including rituximab, have expired or will expire in the near future and, in many regions, access to rituximab remains challenging. Together, these concerns have prompted the development of safe and effective rituximab biosimilars, with the potential to increase access to more affordable treatments.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Journal:  Cellular Cytotoxicity of Next Generation CD20 Monoclonal Antibodies. (Pubmed Central) -  Aug 30, 2019   
    Specific effects on ADCP were evaluated for clinically relevant drug combinations using BTK inhibitors (ibrutinib and acalabrutinib), PI3Kδ inhibitors (idelalisib, ACP-319, and umbralisib), and the BCL2 inhibitor venetoclax...Overall, ADCP was a better measure of clinically relevant mAb-induced cellular cytotoxicity, and next generation mAbs could activate ADCP at significantly lower concentrations, suggesting the need to test a wide-range of dose sizes and intervals to establish optimal therapeutic regimens. Complement activation by mAbs can contribute to ADCP, and venetoclax, acalabrutinib, and umbralisib are preferred candidates for multi-drug therapeutic regimens.
  • ||||||||||  Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, iladatuzumab vedotin (DCDS0780A) / Roche, Rituxan (rituximab) / Roche
    Trial completion, Combination therapy:  A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) -  Aug 29, 2019   
    P1,  N=66, Completed, 
    Complement activation by mAbs can contribute to ADCP, and venetoclax, acalabrutinib, and umbralisib are preferred candidates for multi-drug therapeutic regimens. Active, not recruiting --> Completed