- |||||||||| Review, Journal: Comparative Clinical Value of Pharmacologic Therapies for B-Cell Chronic Lymphocytic Leukemia: An Umbrella Analysis. (Pubmed Central) - Apr 13, 2022
In naïve patients, the PFS hazard ratios associated with four recent chemo-free therapies (obinutuzumab- and/or acalabrutinib-based) ranged from 0.11 to 0.61 versus current standard treatments (STs), without a significant OS advantage...In conclusion, last-generation therapies for CLL consistently increase PFS, but not OS, and minimally decrease safety, as compared with STs. Based on available evidence, the patient-customized adoption of new therapies, rather than universal recommendations, seems desirable in CLL patients.
- |||||||||| Review, Journal: New and Old Anti-CD20 Monoclonal Antibodies for Nephrotic Syndrome. Where We Are? (Pubmed Central) - Apr 9, 2022
Studies already performed with ofatumumab given in standard doses of 1,500 mg 1.73m suggest no superiority compared to rituximab in children and young adults with steroid dependent nephrotic syndrome...In the unique study performed in patients with multidrug dependent nephrotic syndrome reporting positive effects, obinutuzumab was associated with the anti-CD38 monoclonal antibody daratumumab proposing the unexplored frontier of combined therapies...Results of randomized trials, now in progress, are awaited to add new possibilities in those cases that are resistant to other drugs. The aim of the present review is to open a discussion among nephrologists, with the hope to achieve shared approaches in terms of type of antibodies and doses in the different proteinuric renal conditions.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment open: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov) - Apr 8, 2022
P1, N=12, Recruiting,
PRO data from the GIBB study show improved overall HRQoL in patients with CLL who received first-line chemoimmunotherapy with BG. Not yet recruiting --> Recruiting
- |||||||||| Review, Journal: The Future of Natural Killer Cell Immunotherapy for B Cell Non-Hodgkin Lymphoma (B Cell NHL). (Pubmed Central) - Apr 6, 2022
However, over the last 5 years, adoptive immunotherapy with effector lymphocytes of B cell NHL has experienced tremendous growth, with five different CAR T cell products now licensed by the FDA, four of which target CD19 and have approved indications for some subtype of B cell NHL-axicabtagene ciloleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, and tisagenlecleucel...This renewed interest in the potential of cellular immunity-and the manufacturing, supply chain, and administration logistics that have been addressed with these new agents-have ignited a new wave of enthusiasm for NK cell-directed therapies in NHL. With high safety profiles and proven anti-lymphoma efficacy, one or more new NK cell-directed modalities are certain to be introduced into the standard toolbox of NHL therapy within the next few years, be it function-enhancing cytokine muteins, multi-domain NK cell engagers, or adoptive therapy with expanded or genetically modified NK cells.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial initiation 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) - Apr 5, 2022
P2, N=30, Recruiting,
With high safety profiles and proven anti-lymphoma efficacy, one or more new NK cell-directed modalities are certain to be introduced into the standard toolbox of NHL therapy within the next few years, be it function-enhancing cytokine muteins, multi-domain NK cell engagers, or adoptive therapy with expanded or genetically modified NK cells. Initiation date: Mar 2022 --> Jun 2022
- |||||||||| Pixuvri (pixantrone) / Servier, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Combination therapy: GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma (clinicaltrials.gov) - Apr 1, 2022
P2, N=70, Completed,
No abstract available Active, not recruiting --> Completed
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - Mar 29, 2022
P1b/2, N=130, Recruiting,
OBZ effectively depleted B-cell counts in sensitized kidney-transplant candidates and, unlike RTX, had no effect on CDC crossmatch results. Trial completion date: Mar 2023 --> Jun 2025 | Trial primary completion date: Mar 2023 --> Jun 2024
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Review, Journal: Acalabrutinib and its use in the treatment of chronic lymphocytic leukemia. (Pubmed Central) - Mar 26, 2022
The triple combination with venetoclax showed a high rate of molecular remission without an impaired safety profile. Adverse events, with an occurrence rate of >20%, were as follows: grade 1-2 myelosuppression, gastrointestinal toxicity, rash, constitutional symptoms; grade 3 or 4 toxicities were syncope, pneumonia, hypertension, atrial fibrillation, neutropenia and thrombocytopenia.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal, Patient reported outcomes: Patient-reported outcomes provide prognostic information for survival in patients with diffuse large B-cell lymphoma: Analysis of 1239 patients from the GOYA study. (Pubmed Central) - Mar 25, 2022
Adverse events, with an occurrence rate of >20%, were as follows: grade 1-2 myelosuppression, gastrointestinal toxicity, rash, constitutional symptoms; grade 3 or 4 toxicities were syncope, pneumonia, hypertension, atrial fibrillation, neutropenia and thrombocytopenia. In this large population of patients with DLBCL, pretreatment PROs provided prognostic information for OS and PFS beyond the well-established IPI.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date: Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation (clinicaltrials.gov) - Mar 25, 2022
P2, N=200, Recruiting,
In this large population of patients with DLBCL, pretreatment PROs provided prognostic information for OS and PFS beyond the well-established IPI. Trial primary completion date: Feb 2022 --> Jan 2024
- |||||||||| Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal, Real-world evidence: Examining Treatment Patterns and Real-World Outcomes in Chronic Lymphocytic Leukemia Using Administrative Data in Ontario. (Pubmed Central) - Mar 24, 2022
Survival in patients treated with frontline chlorambucil was 76% pre-2015 and 75% post-2015 in year 1, and 45% and 56% in year 3. Our analysis shows that, as the treatment landscape for CLL has shifted, use of newer and novel agents as a first line or earlier in the relapsed/refractory setting has resulted in improved survival outcomes.
- |||||||||| Review, Journal: New Treatment Options in Lupus Nephritis. (Pubmed Central) - Mar 24, 2022
Unanswered questions related to the use of these new drugs are discussed. Recent trials have opened new avenues for the treatment of LN which will hopefully reduce the rate of chronic kidney disease.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal, IO biomarker: Current Treatment of Chronic Lymphocytic Leukemia: The Diminishing Role of Chemoimmunotherapy. (Pubmed Central) - Mar 23, 2022
While novel-agent-based front-line approaches are appropriate for most patients, fludarabine, cyclophosphamide, and rituximab (FCR) remains a consideration for a selected population of young patients with immunoglobulin heavy chain variable region gene (IGHV)-mutated disease because of the possibility of a prolonged remission following FCR...Finally, we examine therapies with combinations of novel agents, and novel agents in development, including covalent and noncovalent BTK inhibitors, PI3K inhibitors, B-cell lymphoma 2 (BCL2) inhibitors, immunotherapies, and cellular therapies. With effective approved options and new agents in development, the role of chemoimmunotherapy in the management of CLL has diminished.
- |||||||||| glofitamab (RG6026) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Glofitamab plus Obinutuzumab (Twitter) - Mar 19, 2022
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal, IO biomarker: Prognostic mutational subtyping in de novo diffuse large B-cell lymphoma. (Pubmed Central) - Mar 18, 2022
P1/2, P3
This analysis supports the utility of NMF used in conjunction with targeted sequencing platforms for identifying patients with different prognostic subsets. The observed trend for improved overall survival in the BCL2/EZH2 group is consistent with the mechanism of action of venetoclax, suggesting that targeting sequencing and NMF has potential for identifying patients who are more likely to gain benefit from venetoclax therapy.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Trial primary completion date: OLYMP-1: Obinutuzumab in Marginal Zone Lymphoma (clinicaltrials.gov) - Mar 15, 2022
P2, N=56, Recruiting,
This may contribute to the development of potential therapeutic alternatives for patients with B-cell malignancies. Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| Phase classification, 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) - Mar 15, 2022
P1, N=172, Recruiting,
Trial primary completion date: Dec 2021 --> Dec 2022 Phase classification: P1b --> P1
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment change, Trial completion date, Trial primary completion date: Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) (clinicaltrials.gov) - Mar 15, 2022
P2, N=127, Recruiting,
Phase classification: P1b --> P1 N=77 --> 127 | Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
P2 data, Journal: Venetoclax consolidation after fixed-duration venetoclax plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (HOVON 139/GiVe): primary endpoint analysis of a multicentre, open-label, randomised, parallel-group, phase 2 trial. (Pubmed Central) - Mar 11, 2022
P2
Modifications in chlorambucil dosing and obinutuzumab administration can improve tolerance without significant loss in efficacy. Consolidation with venetoclax 12-cycle treatment increases the duration of known side-effects and does not prevent the loss of minimal residual disease response and subsequent risk of disease relapse.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Efficacy and safety of obinutuzumab in systemic lupus erythematosus patients with secondary non-response to rituximab. (Pubmed Central) - Mar 11, 2022
Obinutuzumab appears to be effective and steroid-sparing in renal and non-renal SLE patients with secondary non-response to rituximab. These patients have severe disease with few treatment options but given responsiveness to B cell depletion, switching to humanised type-2 anti-CD20 therapy is a logical approach.
- |||||||||| Arzerra (ofatumumab) / Novartis, Genmab
Journal, IO biomarker: In Silico Designed Gain-of-Function Variants of Complement C2 Support Cytocidal Activity of Anticancer Monoclonal Antibodies. (Pubmed Central) - Mar 11, 2022
Based on the homology between AP and CP components, we modified the CP component C2 so that it emulates the known pathogenic mutations in the AP component, factor B. By using tumor cell lines and patient-derived leukemic cells along with a set of clinically approved immunotherapeutics, we showed that the supplementation of serum with recombinant GoF C2 variants not only enhances the cytocidal effect of type I anti-CD20 mAbs rituximab and ofatumumab, but also lowers the threshold of mAbs necessary for the efficient lysis of tumor cells and efficiently exploits the leftovers of the drug accumulated in patients' sera after the previous infusion. Moreover, we demonstrate that GoF C2 acts in concert with other therapeutic mAbs, such as type II anti-CD20, anti-CD22, and anti-CD38 specimens, for overcoming cancer cells resistance to complement attack.
- |||||||||| rhIL-15 / National Cancer Institute
Trial termination: Human IL-15 (rhIL-15) and Obinutuzumab for Relapsed and Refractory Chronic Lymphocyte Leukemia (clinicaltrials.gov) - Mar 10, 2022
P1, N=1, Terminated,
Moreover, we demonstrate that GoF C2 acts in concert with other therapeutic mAbs, such as type II anti-CD20, anti-CD22, and anti-CD38 specimens, for overcoming cancer cells resistance to complement attack. Completed --> Terminated; The study was closed after > 1 year of inactivity.
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