- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Obinutuzumab in Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome in Children. (Pubmed Central) - Dec 17, 2023
These results identified low-dose obinituzumab as a promising treatment option in children with steroid-dependent or frequently relapsing nephrotic syndrome, including those resistant to rituximab. The tolerance profile of obinutuzumab was similar to that of rituximab, but hemogram and immunoglobulin levels should be monitored.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Biomarker, P3 data, Journal, Residual disease, Minimal residual disease: Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. (Pubmed Central) - Dec 14, 2023
P3
MRD status can determine outcome after induction and during maintenance, and MRD negativity is a prerequisite for long-term disease control in FL. The higher MRD responses after G- versus R-based treatment confirm more effective tumor cell clearance.
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, RG7827 / Roche
Enrollment closed, 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) - Dec 13, 2023
P1/2, N=80, Active, not recruiting,
The higher MRD responses after G- versus R-based treatment confirm more effective tumor cell clearance. Recruiting --> Active, not recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Thrombospondin Type-1 Domain 7A (TSHD7A) Membranous Nephropathy: Rapid Remission After Obinutuzumab (Type II Anti-CD20) Treatment (Green Room (Sunset Center)) - Dec 13, 2023 - Abstract #WRMC2024WRMC_523;
Case Report: Patient is a 73 year old Russian female who had a history of hepatitis B (treated with Entecavir) and NAFLD...Rituximab (Type 1 Anti-CD20) has been successfully used to treat MN and was shown to be noninferior to cyclosporine...Here, TSHD7A+ MGN responded rapidly to obi treatment with complete remission. Clinical Course of TSHD7A Membranous GN after Anti-CD20 Treatment.
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Rare Case of Pontine bleed as an adverse effect of Acalabrutinib (Ninth Avenue & Dolores St.) - Dec 13, 2023 - Abstract #WRMC2024WRMC_276;
Acalabrutinib should be considered in any patient presenting with hemorrhage of any organ including the brain and medication should be discontinued swiftly. Further studies need to be considered to determine percentage of serious hemorrhage in patients treated with Acalabrutinib.
- |||||||||| Journal: Dual-targeted regimens for the frontline treatment of CLL. (Pubmed Central) - Dec 9, 2023
These dual-targeted regimens provide remarkable efficacy while allowing for an all-oral approach and fixed duration of treatment. Current investigations under way are evaluating the utility of a triplet approach with the addition of obinutuzumab in comparison to a doublet approach.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Effective Prevention of Steroid-Requiring Chronic Gvhd with B Cell Depletion: A Randomized, Placebo-Controlled Trial (Stars at Night B1 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_671;
167 subjects followed for >1 year from HSCT (84 Obin, 83 placebo) are presented here. The primary endpoint, the cumulative incidence (CI) of SR-cGVHD at 12 months from HSCT, was significantly reduced with Obin in comparison with placebo: 11% vs 38%, p=0.008, Fig 1.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Modified Premedication of Infusion Reaction with Obinutuzumab Therapy (Pubmed Central) - Dec 5, 2023
It also had no effect on infectious diseases. Increased doses of corticosteroids were well tolerated and suggested as an effective method for reducing the frequency of IR.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
P3 data, Journal, IO biomarker: Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial. (Pubmed Central) - Dec 4, 2023
P3
Increased doses of corticosteroids were well tolerated and suggested as an effective method for reducing the frequency of IR. After 4 years of follow-up, ibrutinib-venetoclax continues to significantly prolong progression-free survival (vs chemoimmunotherapy) in patients with previously untreated chronic lymphocytic leukaemia, supporting its use as a first-line option.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Journal, Stroma: Stromal cell inhibition of anti-CD20 antibody mediated killing of B-cell malignancies. (Pubmed Central) - Nov 29, 2023
This work demonstrates that contact between tumor cells and stromal cells leads to inhibition of Obinutuzumab effector functions and has important implications for future therapies to improve outcomes to anti-CD20 antibodies. A deeper understanding of how anti-CD20 antibodies interact with stromal cells could prove a useful tool to define better strategies to target the micro-environment and ultimately improve patient outcomes in B-cell malignancies.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date: FLUORO: Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy (clinicaltrials.gov) - Nov 28, 2023
P2, N=15, Active, not recruiting,
A deeper understanding of how anti-CD20 antibodies interact with stromal cells could prove a useful tool to define better strategies to target the micro-environment and ultimately improve patient outcomes in B-cell malignancies. Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Oct 2023 --> Apr 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open, Minimal residual disease: VIS: Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL (clinicaltrials.gov) - Nov 18, 2023
P2, N=78, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Retrospective data, Journal: Frequency and outcomes of obinutuzumab-induced thrombocytopenia. (Pubmed Central) - Nov 15, 2023
We illustrate four cases of obinutuzumab-induced thrombocytopenia with a review of the literature. Research is required to identify the pathophysiology and improve early recognition and management of the condition in the context of multiagent chemotherapy.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion: CLL2-BAAG: Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL (clinicaltrials.gov) - Nov 15, 2023
P2, N=46, Completed,
Research is required to identify the pathophysiology and improve early recognition and management of the condition in the context of multiagent chemotherapy. Active, not recruiting --> Completed
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Nov 7, 2023
P2, N=81, Active, not recruiting,
Trial completion date: Jul 2027 --> Feb 2029 | Trial primary completion date: Sep 2026 --> Mar 2027 Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment open, Combination therapy: NP30179: A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Nov 7, 2023
P1/2, N=860, Recruiting,
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025 Active, not recruiting --> Recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment change, Trial completion date, Trial primary completion date: POSTERITY: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants (clinicaltrials.gov) - Nov 7, 2023
P2, N=40, Recruiting,
Active, not recruiting --> Recruiting N=30 --> 40 | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2025 --> Mar 2026
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date, Combination therapy: Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Nov 7, 2023
P2, N=52, Recruiting,
N=30 --> 40 | Trial completion date: Mar 2027 --> Mar 2029 | Trial primary completion date: Mar 2025 --> Mar 2026 Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Real-World Use and Outcomes of Therapies, Including Venetoclax-Based Treatments, after Discontinuation of a Covalent BTK Inhibitor in Patients with Chronic Lymphocytic Leukemia/Small Lymphoc... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6624;
Patients with CLL/SLL aged 18 years or older were included who received at least one cBTKi (ibrutinib, zanubrutinib, or acalabrutinib) and at least one additional line of treatment immediately after their initial cBTKi treatment discontinuation from December 01, 2011, through March 31, 2022...Twenty-three percent (n=288) of patients received venetoclax-containing regimens as the immediate post-cBTKi therapy, with 10% (n=120) who received venetoclax monotherapy (VenMono), 5% (n=63) venetoclax plus rituximab (VenR), and 8% (n=105) venetoclax plus other (e.g., chemoimmunotherapy, obinutuzumab)...In addition, outcomes for patients treated in the post-cBTKi setting appear to be suboptimal overall. These data suggest the need for additional treatment options and sequencing data to determine the best treatment strategy following the discontinuation of initial cBTKi therapy.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Real-World Patterns of Care and Financial Burden of Patients with Follicular Lymphoma in the United States (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6609;
Real-world treatment patterns for patients with FL were shown to be mostly consistent with clinical guidelines. This study highlighted that TTNT decreased while hospitalizations and pharmacy costs increased as line of therapy progressed, suggesting high financial burden and unmet need for better treatment options for R/R FL patients.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Real-World Venetoclax-Obinutuzumab in 232 Treatment Naive CLL Patients: Feasibility and Tolerability (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6096;
Furthermore, TLS and IRR were in line with clinical trials. Longer follow-up data will be reported at the meeting allowing by multivariate analysis to better clarify the role of comorbidities on treatment management and the reproducibility of VO tolerability in common clinical practice.
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Elevate-TN: Impact of First-Year Dose Modifications in Patients with Treatment-Naive Chronic Lymphocytic Leukemia Treated with Acalabrutinib (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6095;
P3
OS outcomes in patients who required dose reductions or breaks but did not discontinue treatment in the first year were similar to those in patients who did not require dose modification. Accepting the limitations of retrospective analysis, these data suggest that patients who are unable to tolerate standard-dose acala or who require treatment breaks may benefit from continuing or resuming treatment at a reduced dose rather than stopping treatment altogether.
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Analysis of Ventricular Arrhythmias and Sudden Death with Acalabrutinib from 5 Prospective Clinical Trials (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6093;
Accepting the limitations of retrospective analysis, these data suggest that patients who are unable to tolerate standard-dose acala or who require treatment breaks may benefit from continuing or resuming treatment at a reduced dose rather than stopping treatment altogether. Incidence and relative risk of nonfatal and fatal VAs and SDs were analyzed using pooled data from 5 prospective acalabrutinib clinical trials (nonrandomized trials: CL-001 [acalabrutinib monotherapy], CL-003 [acalabrutinib + obinutuzumab]; randomized trials: CL-006 [acalabrutinib vs ibrutinib], CL-007 [acalabrutinib
- |||||||||| Yinuokai (orelabrutinib) / InnoCare, Biogen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6092;
P2
Incidence and relative risk of nonfatal and fatal VAs and SDs were analyzed using pooled data from 5 prospective acalabrutinib clinical trials (nonrandomized trials: CL-001 [acalabrutinib monotherapy], CL-003 [acalabrutinib + obinutuzumab]; randomized trials: CL-006 [acalabrutinib vs ibrutinib], CL-007 [acalabrutinib Background: A phase II trial has shown, first-line treatment with iFCG (ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab) led to a bone marrow (BM) undetectable minimal residual disease (uMRD) rate of 98% (44/45) as best response in treatment-na
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
A Prospective, Phase-II Study to Evaluate the Efficacy and Safety of Obinutuzumab, Ibrutinib, and Venetoclax (GIVeRS) in Patients with Richter's Syndrome (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6090;
P2
In patients with RS triplet treatment with ibrutinib, venetoclax, and obinutuzmab was well tolerated, achieved high rates of early metabolic response (ORR-70% and CRR-40%) at 3 months. Given the high early response rate but subsequent progression, this triplet therapy may serve as a bridge to consolidation with cellular therapy.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Early Complete Responses with Mosunetuzumab Monotherapy in Treatment-Na (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5837;
Dexamethasone prophylaxis was administered through C2D1, and could be omitted after that for patients without CRS in the previous cycle...Pts with SD or PR could receive 6 cycles (21 day cycle, Part B) of polatuzumab vedotin and obinutuzumab, followed by an end of treatment (EOT) PET/CT...No pts required tocilizumab...Injection site reactions and headaches were common but reversible. Safety and efficacy has remained well within study suspension thresholds and accrual is ongoing to a goal of 42 total patients.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Frequency and Outcomes of Obinutuzumab-Induced Thrombocytopenia (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5383;
Methods After obtaining local ethics review, we collected the total number of patients who received Obi as part of multi-agent chemotherapy for the following hematological diseases from 01/01/2015 -01/01/2023: FL (Obi-bendamustine +/- Obi maintenance; Obi-cyclophosphamide/vincristine/prednisone +/-doxorubicin +/- Obi maintenance, Obi-Zanubrutinib (Rosewood trial) and CLL (Obi-venetoclax; Obi-chlorambucil)...Obi was changed to rituximab...It may be self-limiting whereas some cases have been treated with steroids, IVIg, and TPO-RA. Further studies are required to delineate the incidence, pathophysiology, diagnosis, and management.
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