- |||||||||| PSB202 / Sound Biologics
Development of PSB202, a bifunctional antibody pair that target CD20 and CD37, for the treatment of B-cell malignancies (Section 38) - Mar 9, 2022 - Abstract #AACR2022AACR_4832;
P1a/1b
Systemic depletion of normal and malignant B-cells by anti-CD20 antibodies (e.g. rituximab and obinutuzumab) and anti-CD37 antibodies (e.g. otlertuzumab and BI 836826) has been well tolerated in clinical studies...Synergy was demonstrated for PSB202 in combination with lenalidomide...PSB202 offers the potential to improve clinical efficacy, decrease drug resistance, provide administration convenience especially when combining with additional therapeutics, lower the cost for treatment, and reduce the unwanted side effects from chemotherapy. PSB202 is currently being evaluated in patients with previously treated, relapsed, indolent B-cell malignancies (NCT05003141).
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A Probabilistic Cost-Effectiveness Analysis of Venetoclax and Obinutuzumab As a First-Line, 12-Month, Fixed Duration Therapy in Chronic Lymphocytic Leukemia (CLL) in Canada (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_227;
GClb, BR, Clb+R, and Ibr accrued less QALYs and higher costs, VEN+O was the dominant treatment option. Acalabrutinib showed higher QALY gain and substantially higher costs compared to VEN+O, leading to an incremental-cost-effectiveness-ratio (ICER) of $2,139,180/QALY gained and therefore not a cost-effective option.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Obinutuzumab use in Early Relapse of Membranous Nephropathy () - Mar 6, 2022 - Abstract #NKFSCM2022NKF_SCM_572;
The immunologic response was immediate and within 6 weeks the PLA2R level was undetectable. Obinutuzumab is a viable treatment options for MN especially in patient where rituximab is not achieving the desired remission.
- |||||||||| cladribine / Generic mfg., lenalidomide / Generic mfg.
Journal: Mantle cell lymphoma management trends and novel agents: where are we going? (Pubmed Central) - Mar 4, 2022
Epigenetic agents (e.g. cladribine and vorinostat), mammalian target of rapamycin (mTOR) inhibitors (e.g. temsirolimus and everolimus), and monoclonal antibodies and/or antibody-drug conjugates (e.g. obinutuzumab, polatuzumab, and ublituximab) are promising therapeutic agents currently under clinical trial investigation...However, due to its intricate pathology nature and high relapse incidence, there are still unmet needs in developing optimal therapeutic strategies for both frontline and relapsed/refractory settings. The ultimate goal is to develop innovative personalized combination therapy approaches for the purpose of delivering precision medicine to cure this disease.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, RG6333 / Roche
Enrollment open, Combination therapy: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Mar 2, 2022
P1, N=200, Recruiting,
Based on the observed tolerability of G-chemotherapy versus R-chemotherapy, and the comparable efficacy of G-chemotherapy and R-chemotherapy in this analysis, G-chemotherapy cannot be recommended as first-line treatment for MZL. Not yet recruiting --> Recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Preclinical, Journal: Isolation of SARS-CoV-2 in Viral Cell Culture in Immunocompromised Patients With Persistently Positive RT-PCR Results. (Pubmed Central) - Mar 1, 2022
The second patient had marginal zone lymphoma treated with bendamustine and rituximab who had a high viral titer of 2 x 10 PFU/mL...One patient had a high concentration titer of cultivable virus. Further data are needed to determine risk factors for persistent viral shedding and methods to prevent SARS-CoV-2 transmission from immunocompromised hosts.
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov) - Feb 28, 2022
P1, N=46, Active, not recruiting,
Further data are needed to determine risk factors for persistent viral shedding and methods to prevent SARS-CoV-2 transmission from immunocompromised hosts. Trial completion date: Feb 2022 --> Oct 2022 | Trial primary completion date: Feb 2022 --> Oct 2022
- |||||||||| cladribine / Generic mfg.
Review, Journal, Residual disease, Minimal residual disease: Treatment of Classic Hairy Cell Leukemia: Targeting Minimal Residual Disease beyond Cladribine. (Pubmed Central) - Feb 26, 2022
In the last decade, novel biologic insights such as identification of the driver mutation BRAF V600E have initiated the development and clinical investigation of new, chemotherapy-free, targeted drugs in HCL treatment, with encouraging efficacy in early clinical trials aimed at boosting eradication of MRD while optimizing drug tolerability. This review summarizes current clinical trials investigating treatment strategies beyond purine analogues in HCL and discusses clinically relevant obstacles still to overcome.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Follicular Lymphoma (Hilton Anaheim - Ballroom CD) - Feb 25, 2022 - Abstract #ONS2022ONS_176;
This case demonstrates that membranous nephropathy associated with IgG4-related disease can be treated successfully with obinutuzumab. Review Mechanisms of Action and Totality of Evidence available for the use of GAZYVA Review pivotal data from the GALLIUM phase 3 clinical trial in 1L FL Review pivotal data from the GADOLIN phase 3 clinical trial in 1L FL Review the design of the GAZELLE phase 4 clinical trial Review Important Safety Information Genentech
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date, Combination therapy: SAKK 35/15: Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients (clinicaltrials.gov) - Feb 25, 2022
P1, N=25, Active, not recruiting,
Review Mechanisms of Action and Totality of Evidence available for the use of GAZYVA Review pivotal data from the GALLIUM phase 3 clinical trial in 1L FL Review pivotal data from the GADOLIN phase 3 clinical trial in 1L FL Review the design of the GAZELLE phase 4 clinical trial Review Important Safety Information Genentech Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Dec 2021 --> Apr 2022
- |||||||||| Columvi (glofitamab-gxbm) / Roche, englumafusp alfa (RG6076) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Phase classification, Combination therapy: A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of RO7227166 in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - Feb 22, 2022
P1, N=362, Recruiting,
In the absence of multi-arm RCTs that include all common regimens, this NMA provides an important and useful guide to inform treatment decisions. Phase classification: P1/2 --> P1
- |||||||||| Journal: Is there a role for anti-CD20 antibodies in CLL? (Pubmed Central) - Feb 19, 2022
Alternatively, addition of a glycoengineered anti-CD20 mAb obinutuzumab to a more selective BTKi acalabrutinib may improve PFS but does not improve overall survival of patients with CLL in the frontline setting, pending long-term follow-up...In this review, we discuss clinical trials of BTKis and venetoclax that have investigated the role of anti-CD20 mAbs in frontline and relapsed settings of CLL treatment. We also provide an algorithm suggesting how anti-CD20 mAbs may be incorporated in the treatment of patients with CLL, including specific scenarios.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, IO biomarker: Frontline treatment in CLL: the case for time-limited treatment. (Pubmed Central) - Feb 19, 2022
Initially, the bcl-2 inhibitor venetoclax (VEN) was used as a single agent and then was rapidly combined in VEN-based regimens associated with either anti-CD20 or with BTKi...Fit patients with a TP53 wild type and IGHV-mutated CLL may still benefit from fludarabine-cyclophosphamide-rituximab chemoimmunotherapy (CIT), as it may result in a very long remission duration...The 1-year fixed-duration association of VEN plus obinutuzumab was evaluated in frontline for older adult patients...The association of VEN and BTKi is promising, even if the follow-up is still short. It is currently being tested against CIT, BTKi continuous treatment, and VEN plus anti-CD20.
- |||||||||| REGEN-COV (casirivimab/imdevimab) / Regeneron, Roche
Successful Use of Casirivimab/Imdevimab in B-Cell Depletion Associated Prolonged (B-DEAP) COVID-19 (Area I, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2546;
We present a challenging case of a B-cell depleted patient who had a protracted course of COVID-19 infection despite standard treatment and was successfully treated with an anti-spike protein monoclonal antibody.CASE REPORTA 47-year-old man with a history of follicular lymphoma who was on maintenance therapy with Obinutuzumab was treated with steroids, Remdesevir and antibiotics for a mild COVID-19 infection...Persistently elevated inflammatory markers were concerning for multisystem inflammatory syndrome (MIS-A), thus the patient was given intravenous immunoglobulin (IVIG) and Anakinra with transient improvement of symptoms...Anti-spike protein monoclonal antibodies may be a treatment option in humoral immunodeficiency states, including iatrogenically B-cell depleted patients who do not respond to standard therapy. Additional studies are needed to evaluate the safety and utility of REGN-COV2 in the treatment of COVID-19 infection in this subset of patients.
- |||||||||| B-Cell Depletion Associated Prolonged COVID-19 and Response to Treatment with Monoclonal Antibodies: A Case Series (Area J, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_868;
Those with B-cell depletion due to therapies like Rituximab and Obinutuzumab, often experience more protracted courses, as demonstrated in this cohort. Immunocompetent patients have seroconversion at 7-14 days after symptom onset in most cases, but patients with B-cell depletion may fail to develop neutralizing antibodies weeks to months after.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion: Combination of Obinutuzumab and Venetoclax in Relapsed or Refractory DLBCL (clinicaltrials.gov) - Feb 16, 2022
P2, N=22, Completed,
Despite marked 5-year OS for many regimens, a differential 5-year OS benefit could not be ascertained. Active, not recruiting --> Completed
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial initiation date: ORION: Obinutuzumab in Primary MN (clinicaltrials.gov) - Feb 16, 2022
P2, N=20, Not yet recruiting,
Active, not recruiting --> Completed Initiation date: Dec 2021 --> Mar 2022
- |||||||||| Journal: From sequential to combination and personalised therapy in lupus nephritis: moving towards a paradigm shift? (Pubmed Central) - Feb 15, 2022
We also discuss the prospect of obinutuzumab and anifrolumab, also on top of standard immunosuppression, currently tested in phase III trials after initial auspicious signals...This has to be addressed in biomarker surveys along with tissue-level mapping of inflammatory phenotypes, which will ultimately lead to person-centred therapeutic approaches. After many years of trial failures, we may now anticipate a heartening future for patients with lupus nephritis.
- |||||||||| 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) - Feb 11, 2022
P2, N=27, Recruiting,
Recruiting --> Suspended Trial primary completion date: Oct 2021 --> Oct 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Zelboraf (vemurafenib) / Roche
Trial completion date, Trial primary completion date: A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia (clinicaltrials.gov) - Feb 8, 2022
P2, N=30, Active, not recruiting,
These findings translate into a superior long-term efficacy with the majority of Ven-Obi-treated patients remaining in remission. Trial completion date: Jan 2022 --> Jan 2023 | Trial primary completion date: Jan 2022 --> Jan 2023
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab
Clinical, Journal: Survival of patients with chronic lymphocytic leukemia before and after the introduction of chemoimmunotherapy in Germany. (Pubmed Central) - Feb 1, 2022
In CLL patients aged 15-69 years 5-year RS increased from 83% to 90% for men and from 82% to 94% for women after adding an anti-CD20-antibody to chemotherapy while in the older age group of 70-79-year-old CLL patients an increase by 20 percentage points was observed. These findings show marked improvements in the survival of CLL patients at the population level subsequently to the approval of anti-CD 20 antibodies like rituximab, ofatumumab or obinutuzumab for CLL treatment.
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