- |||||||||| Columvi (glofitamab-gxbm) / Roche, Rituxan (rituximab) / Roche
Enrollment open, Combination therapy: GO43693: A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma (clinicaltrials.gov) - Oct 21, 2022
P1, N=40, Recruiting,
Collectively, these data support development of mbIL-21-expanded NKs combined with the CD20 antibody obinutuzumab and venetoclax in the treatment of CLL. Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Scaffold-mediated switching of lymphoma metabolism in culture. (Pubmed Central) - Oct 14, 2022
3D culture restrained DLBCL cell line growth and modulated metabolic pathways that trend towards the biological characteristics of patient tumors. Counter-intuitively, this research thereby contends that 3D matrices can be a tool to control tumor function towards a slower growing and metabolically dormant state that better reflects in vivo tumor physiology.
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal, IO biomarker: IRF8 regulates efficacy of therapeutic anti-CD20 monoclonal antibodies. (Pubmed Central) - Oct 14, 2022
Therefore, IRF8 regulates CD20 expression and controls the depleting-capacity of anti-CD20 antibodies. Our results bring novel insights into the pathways underlying resistance to CD20-targeting immunotherapies.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A Novel Approach in a Case of Cryoglobulinemic Glomerulonephritis (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3124;
It is a good alternative to explore. Obinutuzumab is currently not FDA approved for the treatment of cryoglobulinemic glomerulonephritis, and is being investigated for the treatment of lupus nephritis and membranous nephropathy.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Machine-Learning-Quantified Lupus Nephritis Histological Features Correlate With NIH Activity and Chronicity Index Subscores (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_2420;
P2
Methods 374 hematoxylin and eosin (H&E)-stained whole-slide images (WSI) of non-LN kidney and LN biopsies were obtained, mainly from a LN cohort at the University of Geneva and a clinical trial of obinutuzumab (OBZ) in proliferative LN (NCT02550652)...The findings demonstrate the feasibility of ML for quantifying LN histologic features. The utility of this approach in predicting treatment response is being evaluated.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A Case of Focal Immune-Complex Membranoproliferative Glomerulonephritis (MPGN) in Low-Risk Chronic Lymphocytic Leukemia (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1973;
No tumor lysis syndrome was observed during treatment, although thrombocytopenia, a rare adverse effect of Obinutuzumab, did occur together with AKI, the latter possibly due to tubular obstruction by red blood cells casts. Longer follow-up is needed to determine treatment efficacy of Ven-Obi in CLL-R.
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Obinutuzumab-Containing Multimodality Induction in Kidney Transplantation (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1662;
Patients received eculizumab 900 mg prior graft reperfusion...As maintenance, we used LCP-tacrolimus (C0, 10-15 ng/mL), mycophenolate mofetil (MMF, 2000 mg/day), and prednisone...Also, obinutuzumab-induced B-cell depletion appears to be uneffected by concomitant complement inhibition. Such encouraging findings should prompt further investigation.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Screening for Anti-Rituximab Antibody in Management of Rituximab Refractory PLA2R-Associated Membranous Nephropathy (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1536;
Within a month of OBI, anti-PLA2R Ab came down to 25 RU/mL.UPCR was 2.19 g/g & S.A 3.5 g/dL at 14 months thus denoting P.R and near complete I.R. Discussion This case report highlights the clinical utility of anti-RTX Ab screening when managing patients with refractory PLA2R-MN. The presence of anti-RTX should prompt the use of new generation (more humanized) anti-CD20 therapy to achieve immunologic and clinical remission.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Refractory Membranous Nephropathy With Anti-Rituximab Antibodies Treated Successfully With Obinutuzumab (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1533;
While the use of Obinutuzumab has been described in limited case reports for the treatment of refractory membranous nephropathy, anti-rituximab antibodies have not been described in refractory disease. Patient Course
- |||||||||| Tazverik (tazemetostat) / Eisai, Ipsen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Standard treatment and future perspectives for follicular lymphoma (Pubmed Central) - Oct 13, 2022
Recently, lenalidomide and tazemetostat have been approved in Japan. This manuscript outlines the treatment strategy for untreated and relapsed FL and discusses future issues.
- |||||||||| Nplate (romiplostim) / Amgen, Kyowa Kirin, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A Case of Hypereosinophilia in a Patient with Evans Syndrome (Exhibit Hall (Upper Concourse); Monitor 07) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_961;
Discussion We present this case to demonstrate novel exposures which may have precipitated an uncommon cause of hypereosinophilia. We hope this may provide insight into evaluating patients with unclear causes of hypereosinophilia, especially as exposures to marijuana and biologic medications continue to grow.
- |||||||||| Kesimpta (ofatumumab subcutaneous) / Novartis, Genmab
A Successful Desensitization to Ofatumumab (Exhibit Hall (Upper Concourse); Monitor 01) - Oct 10, 2022 - Abstract #ACAAI2022ACAAI_814;
Finally, she was given obinutuzumab which was associated with urticarial and angioedema on her first dose...Given that there were no established protocols in the literature, we utilized a rituximab-based protocol that required significant adjustments as ofatumumab has complex dosing requirements, including modifications for dose escalation and maximal concentrations based on its pharmacologic properties. This case report adds to the literature by describing a successfully implemented ofatumumab desensitization protocol in a medically complex patient with hypersensitivity to multiple anti-CD20 monoclonal antibodies
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal, HEOR, Combination therapy: Cost-utility analysis of venetoclax in combination with obinutuzumab as first-line treatment of chronic lymphocytic leukaemia in Spain. (Pubmed Central) - Oct 9, 2022
This case report adds to the literature by describing a successfully implemented ofatumumab desensitization protocol in a medically complex patient with hypersensitivity to multiple anti-CD20 monoclonal antibodies Venetoclax in combination with obinutuzumab is an efficient and dominant alternative for treating previously untreated patients with chronic lymphocytic leukaemia compared to the available alternatives and from the perspective of the Spanish National Health System.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
NKX019, an Off-the-Shelf CD19 CAR-NK Cell, mediates improved anti-tumor activity and persistence in combination with CD20-directed therapeutic mAbs (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1214;
P1
Conclusions This study demonstrates increased activity and persistence of NKX019 when used in combination with approved CD20-targeted mAbs, RTX and OBI, against B cell malignancies. A first-in -human Phase I clinical trial of NKX019 in combination with RTX is planned.
- |||||||||| AB-101 / Artiva Biotherap
Evaluation of AB-101, an Allogeneic Cord Blood-derived Natural Killer (NK) Cell Therapy, as an ADCC Enhancer in Hematologic and Solid Tumors (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_643;
P1/2
In addition, in vivo efficacy of AB-101 and AB-101 in combination with rituximab demonstrated enhanced median survival in the Raji xenograft model and AB-101 in combination with trastuzumab led to enhanced survival in the SKOV-3 xenograft model...AB-101 is currently in a Ph1 clinical trial to evaluate the safety and anti-tumor activity alone and in combination with rituximab in patients with relapsed or refractory NHL (ClinicalTrials.gov: NCT04673617 ). Ethics Approval All animal work was conducted under reviewed IACUC protocol and with approval of an IACUC committee at each center where the studies took place.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Journal, Circulating tumor DNA: Circulating tumor DNA-based MRD assessment in patients with CLL treated with obinutuzumab, acalabrutinib and venetoclax. (Pubmed Central) - Oct 5, 2022
Ethics Approval All animal work was conducted under reviewed IACUC protocol and with approval of an IACUC committee at each center where the studies took place. Based on these findings, ctDNA-based MRD assessment appears to be a promising method to complement cell-based MRD approaches like flow cytometry that focus on circulating CLL cells in the peripheral blood.
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, RG7827 / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov) - Oct 5, 2022
P1/2, N=80, Recruiting,
The evidence generated this way contributes to define the place in therapy of individual agents. Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Oct 2024 --> Jul 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
P2 data, Clinical Trial,Phase II, Journal, IO biomarker: Obinutuzumab, acalabrutinib, and venetoclax, after an optional debulking with bendamustine in relapsed or refractory chronic lymphocytic leukaemia (CLL2-BAAG): a multicentre, open-label, phase 2 trial. (Pubmed Central) - Oct 4, 2022
P2
Triple therapy with obinutuzumab, acalabrutinib, and venetoclax after an optional debulking with bendamustine regimen requires further evaluation in larger trials to define its value compared with double treatment with a BTK or BCL2 inhibitor combined with obinutuzumab or a combination of the two oral targeted drugs. Until these trials show a clear benefit, the use of the triple combination in routine practice cannot be recommended.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: 17P.176: Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (clinicaltrials.gov) - Oct 3, 2022
P2, N=30, Recruiting,
Until these trials show a clear benefit, the use of the triple combination in routine practice cannot be recommended. Trial completion date: Jan 2022 --> Dec 2023 | Trial primary completion date: Nov 2021 --> Dec 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Clinical, Journal, Residual disease, IO biomarker, Minimal residual disease: CLL-106 First Prospective Data on Minimal Residual Disease Outcomes After Fixed-Duration Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for First-Line Treatment of CLL in Older Adult or Unfit Patients: The GLOW Study. (Pubmed Central) - Sep 29, 2022
P3
Recruiting --> Active, not recruiting All-oral, once-daily, fixed-duration Ibr+Ven demonstrated superior uMRD responses that were deeper and better sustained post-treatment versus Clb+O in older adult or unfit patients with previously untreated CLL.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: O-ICE: Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL (clinicaltrials.gov) - Sep 28, 2022
P2, N=25, Recruiting,
Hence, the 1-year fixed-duration Ven-Obi regimen continues to be an effective fixed-duration option for patients with CLL, also in the context of high-risk disease. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Unique Paraneoplastic Syndrome Associated with CLL (West/Central Hall) - Sep 28, 2022 - Abstract #SNO2022SNO_835;
She failed trials of Pembrolizumab, ibrutinib, and Obinutuzumab due to side effects...She was then trialed on intravenous methylprednisolone and still experienced no relief...Finally, she was given rituximab infusions with slight improvement...This case is unique in that her symptoms presented with an ataxic syndrome with positive KLHL11 antibodies. It is important to be aware that some cases of CLL can present with unique paraneoplastic syndromes.
- |||||||||| Bispecifi c Antibodies for Aggressive B-Cell Lymphoma () - Sep 22, 2022 - Abstract #SOHO2022SOHO_390;
P1, P1/2,
NCT03533283 and or mosunetuzumab, NCT03677154); and lenalidomide or the CElMoDs (NCT05169515, NCT05335018, NCT02568553)...Data from arm 1 of this study using fi rst-line epcoritamab+R-CHOP for high-risk DLBCL has demonstrated an overall response rate of 96%.2 A cohort of transplant-eligible R/R DLBCL patients who received salvage epcoritamab+R-DHAX/C with subsequent ASCT or epcoritamab monotherapy demonstrated OR and CR rates of 82.6% and 60.9%...Conclusion Clinical data indicate that BsAbs will earn a place in regular treatment of relapse aggressive lymphoma. There is broad development potential in earlier lines of therapy and as a salvage following CAR-T cell therapy.
- |||||||||| Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical Signifi cance of B-Cell Receptor Stereotype in CLL () - Sep 22, 2022 - Abstract #SOHO2022SOHO_386;
This suggests that CIT may be less optimal for subset #2 patients, while also highlighting the usefulness of this information for risk stratifi cation of patients, a practice already followed by different study groups worldwide. In that regard, it is relevant to mention the results of the NCRI FLAIR trial, where a hazard ratio for disease progression and death of 0.32 was reported for subset #2 patients treated with FCR versus IR, though not reaching statistical signifi cance (p =0.191), likely due to low numbers (FCR, n =20; IR, n =26).21 Subset #8 includes patients with U-CLL expressing BcR IG encoded by the IGHV4-39/IGKV1(D)-39 genes with distinctive, restricted VH and VK CDR3 sequences.22,23 Subset #8 displays a signifi cant enrichment for trisomy 12 and NOTCH1 mutations, offering yet another example of subset-biased profi les of genomic aberrations.11-13,15 In the original report of subset #8 it was noted that 2 of 5 patients belonging to subset #8 experienced Richter’s transformation.22 This initial observation was subsequently corroborated by a collaborative study from Italy reporting that patients belonging to subset #8 had a 10-fold higher risk for this development compared to all other patients with CLL.17 Subsequently, the meta-analysis of 3 prospective clinical trials conducted by the German CLL Study Group showed that patients belonging to subset #8 experienced the highest risk of Richter’s transformation, albeit the incidence was lower.16 On these grounds, ERIC, the European Research Initiative on CLL, recommends closer follow-up and a lower threshold for a fl uorodeoxyglucose positron emission tomography (PET)/ CT guided biopsy for subset #8 patients experiencing evidence of disease progression (also under therapy) in order to exclude the possibility of Richter’s transformation.24
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Review, Journal, IO biomarker: Management of front line chronic lymphocytic leukemia. (Pubmed Central) - Sep 22, 2022
Although these agents have usually manageable side effects, toxicities might limit choices for the individual patient. We here discuss latest trial data and propose a treatment algorithm for frontline treatment of CLL according to fitness and relevant genetic risk factors like IGHV mutational status and TP53 aberrations.
- |||||||||| Benlysta (belimumab) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: B cells in systemic lupus erythematosus: Targets of new therapies and surveillance tools. (Pubmed Central) - Sep 20, 2022
In addition, terminally differentiated B cells have also been the targets of experimental therapies, with the proteasome inhibitor bortezomib being one example...Inadequate B cell depletion may signify poor expected clinical response to rituximab, for example, while prominent reductions in certain B cell subsets may signify a protection against flare development in patients treated with belimumab. Toward an era with a richer therapeutic armamentarium in SLE, including to a large extent B cell altering treatments, the challenge that emerges is to determine diagnostic means for evidence-based therapeutic decision-making, that uses clinical information, serological markers, and gene expression patterns to guide individualized precision strategies.
- |||||||||| Darzalex (daratumumab) / J&J
Daratumumab enables sustained remission after Immunoadsorption in Refractory Multidrug Resistant Nephrotic Syndrome. (Poster Area - Exhibition Hall E) - Sep 20, 2022 - Abstract #IPNA2022IPNA_432;
All were resistant to ciclosporine and/or tacrolimus, 4 also received MMF and 3 rituximab (RTX)...All patients achieved complete remission after IA but relapsed after a first discontinuation attempt, despite B-cell depletion with RTX(n=3) or Obinutuzumab (OBI) (n=3)...The association of plasma-cell depletion with daratumumab to B-cell depletion allowed IA discontinuation in all patients. Further studies are needed to confirm the efficacy of daratumumab in children with MRNS and better define its place in the treatment strategy.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date: Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG) (clinicaltrials.gov) - Sep 16, 2022
P2, N=66, Active, not recruiting,
This study will address key unanswered questions in frontline chronic lymphocytic leukemia/small lymphocytic lymphoma therapy by investigating the optimal duration of finite treatment and identifying the optimal venetoclax doublet regimen. Trial completion date: Sep 2022 --> Nov 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: A Biphasic COVID-19 Clinical Course in Anti-CD20 Treated Patients: Case Series and Review of the Literature. (Pubmed Central) - Sep 14, 2022
Trial completion date: Sep 2022 --> Nov 2024 Four cases of COVID-19 infection in anti-CD20 treated patients are described.These cases display a unique biphasic course that was previously undescribed: respiratory deterioration weeks after convalescence.Awareness of such a course and rapid utilisation of bronchoalveolar lavage will lead to quicker diagnosis and more timely, appropriate treatment.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date: NOBILITY: A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) (clinicaltrials.gov) - Sep 14, 2022
P2, N=126, Active, not recruiting,
Four cases of COVID-19 infection in anti-CD20 treated patients are described.These cases display a unique biphasic course that was previously undescribed: respiratory deterioration weeks after convalescence.Awareness of such a course and rapid utilisation of bronchoalveolar lavage will lead to quicker diagnosis and more timely, appropriate treatment. Trial completion date: Jul 2022 --> Oct 2022
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