- |||||||||| Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen
Obinutuzumab in Pediatric Idiopathic Nephrotic Syndrome Resistant to Rituximab (Exhibit Hall, Walter E. Washington Convention Center) - Oct 14, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_4632; A single low dose injection resulted in longer B-cell depletion compared to rituximab. However, short term and long term immunological and infectious side effects have to be closely monitored.
- |||||||||| 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.
- |||||||||| Gazyva (obinutuzumab) / Biogen, Roche, Rituxan (rituximab) / Roche, Biogen, bendamustine / SymBio, Mundipharma, Astellas, Generic Mfg.
Review, Journal: Obinutuzumab with Bendamustine for Treating Follicular Lymphoma Refractory to Rituximab: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. (Pubmed Central) - Sep 26, 2019 This uncertainty is expected to be reduced when the final analysis of the GADOLIN trial is reported. Consequently, the NICE appraisal committee recommended O-Benda+O in the population covered by the marketing authorisation within the Cancer Drug Fund until NICE is able to review the guidance following publication of the final analysis of GADOLIN.
- |||||||||| 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, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion, Combination therapy: CAVALLI: A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL (clinicaltrials.gov) - Sep 23, 2019 P1/2, N=267, Completed, Preliminary data indicate that efficacy is maintained with a high proportion of patients with undetectable MRD levels after combination treatment. Active, not recruiting --> Completed
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial primary completion date, Combination therapy: GO29834: A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Sep 19, 2019 P1, N=128, Recruiting, Trial completion date: Feb 2024 --> Jan 2021 Trial primary completion date: Aug 2019 --> Aug 2020
- |||||||||| 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.
- |||||||||| Enrollment closed, Combination therapy: NP40126: A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL (clinicaltrials.gov) - Sep 12, 2019
P1b, N=172, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
New P2 trial, Combination therapy: MOLTO: ObinutuzuMab AtezOlizumab and VenetocLax in RichTer transfOrmation (clinicaltrials.gov) - Sep 9, 2019 P2, N=28, Not yet recruiting,
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