- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Journal: Venetoclax Dose Escalation Rapidly Activates a BAFF/BCL-2 Survival Axis in Chronic Lymphocytic Leukemia. (Pubmed Central) - Oct 29, 2024
Accordingly, analysis of patients with CLL that were treated with venetoclax or the anti-CD20 antibody obinutuzumab exhibited marked elevation of BAFF and increased pro-survival proteins in leukemic cells that persisted. Overall, these data highlight the rapid adaptation of CLL cells to targeted therapies via homeostatic factors and support co-targeting of cytokine signals to achieve deeper and more durable long-term responses.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Columvi (glofitamab-gxbm) / Roche, Brukinsa (zanubrutinib) / BeiGene
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy: GLOASIS: A Phase II Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma (clinicaltrials.gov) - Oct 15, 2024
P2, N=100, Not yet recruiting,
The results of this study showed no efficacy advantage although the combinations were well tolerated. Trial completion date: Dec 2031 --> Mar 2032 | Initiation date: Sep 2024 --> Dec 2024 | Trial primary completion date: Feb 2028 --> May 2028
- |||||||||| Review, Journal: Current Approaches and Novel New Agents in the Treatment of Chronic Lymphocytic Leukemia. (Pubmed Central) - Oct 14, 2024
Promising novel approaches include BTK degraders, bispecific antibodies, and chimeric antigen receptor T-cell (CAR-T)-cell therapy. What is clear is that CIT is archaic, and current and future targeted approaches will continue to improve the outcome for patients with chronic lymphocytic leukemia.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Journal: Obinutuzumab versus rituximab for the treatment of refractory primary membranous nephropathy. (Pubmed Central) - Oct 14, 2024
What is clear is that CIT is archaic, and current and future targeted approaches will continue to improve the outcome for patients with chronic lymphocytic leukemia. This retrospective study suggests that obinutuzumab is an effective treatment option for patients with primary membranous nephropathy refractory to GC+CTX, CNI, and rituximab regimens.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Differences in B-cell repertoire reconstitution after rituximab and obinutuzumab treatment of CLL (Darwin) - Oct 13, 2024 - Abstract #DGHO2024DGHO_1053;
P3
The reconstitution of normal B cells after CLL therapy seems to be confined for a longer time period by Obinutuzumab than by Rituximab, where Obinutuzumab results in lower B cell diversity nine month after therapy. Although the data originally recorded for the purpose of MRD assessment should be used with caution for repertoire analysis, the exploratory analysis will be extended to higher patient numbers.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Treatment Reality of Chronic Lymphocytic Leukemia (CLL) 2019-2022 in Oncology Practices in Germany (Darwin) - Oct 13, 2024 - Abstract #DGHO2024DGHO_1050;
Therapy consists mainly of venetoclax +/- anti-CD20-antibodies and BTKi. Despite the availability of more efficacious modern therapies, chemoimmunotherapy still plays a role in the first-line treatment of CLL, contrary to the guideline recommendations.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Polivy (polatuzumab vedotin-piiq) / Roche, Rituxan (rituximab) / Roche
Update on safety data of the rituximab, polatuzumab vedotin and glofitamab (R-Pola-Glo) regimen for elderly/frail patients with diffuse large B-cell lymphoma (Cairo) - Oct 13, 2024 - Abstract #DGHO2024DGHO_1014;
R-Pola-Glo involves a steroid pre-phase, followed by 6 cycles q3w consisting of polatuzumab vedotin, escalating doses of glofitamab (2.5mg, 10mg, 30mg) and an anti-CD20 antibody (obinutuzumab, C1; rituximab C2-6) followed by additional 6 cycles of glofitamab monotherapy. We present a manageable safety profile of the R-Pola-Glo regimen, warranting its further clinical testing in elderly pts with limited treatment options.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Influence of bone marrow involvement on the extent of anti-CD20 antibody therapy-mediated thrombocytopenia in follicular lymphoma (Guangzhou) - Oct 13, 2024 - Abstract #DGHO2024DGHO_627;
Patients with FL and histopathologic assessment of BMI who received first-line immunochemotherapy with an anti-CD20 mAb (i.e., rituximab or obinutuzumab) were eligible for this retrospective analysis...There were no significant differences in platelet decrease within the groups according to gender, baseline platelet count (150 Gpt/L) or chemotherapy (bendamustine vs. CHOP)...Conclusions : In FL patients, BMI was significantly associated with higher platelet decline, suggesting BMI as a potential risk factor for anti-CD20 therapy-induced thrombocytopenia. Early identification of FL patients at risk for thrombocytopenia associated with anti-CD20 mAb therapy may contribute to better protection through closer monitoring.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
The effect of immunotherapy on liquid biopsy parameters in B-cell non-Hodgkin lymphoma (Geneva 1-2) - Oct 13, 2024 - Abstract #DGHO2024DGHO_564;
Our in vitro experiments as well as our patient-derived data show that immunotherapy massively affects certain liquid biopsy parameters. These changes are not only important to keep in mind for classifying liquid biopsy results but also have diagnostic potential for B-cell lymphoma and other immunotherapy-treated tumor entities
- |||||||||| Management of relapsed and high-risk CLL (Sydney) - Oct 13, 2024 - Abstract #DGHO2024DGHO_30;
Further treatment strategies for CLL with high-risk genetics and/or refractoriness to novel compounds are of high medical need, already addressed in clinical trials with various new substances and combinations. Cellular therapies in particular have the potential for a long lasting response, but are limited by the exhausted T-cell phenotype and consecutive T-cell dysfunction in CLL pts.
- |||||||||| Columvi (glofitamab-gxbm) / Roche
Unveiling the Dual Threat: Glofitamab-Induced AKI via Tumor Lysis and Cytokine Release Syndromes () - Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5371;
His tumor was treated with gemcitabine and oxaliplatin to no avail...Due to CRS risk, the patient received obinutuzumab pretreatment...Within 12 hours, he developed symptoms of CRS (fever, tachycardia, and hypotension) and was sent to ICU, received IV fluids, dexamethasone, and tocilizumab, which assisted with stabilizing his vitals...For TLS, he was treated with IV fluids, sodium zirconium cyclosilicate, and sevelamer...As both CRS and TLS can cause AKI, albeit through different mechanisms, nephrologists should closely monitor patients receiving glofitamab for both syndromes.. . .
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Retrospective data, Journal: Characteristics, efficacy, and prognosis analysis of newly diagnosed marginal zone lymphoma. (Pubmed Central) - Oct 8, 2024
Tailored chemo-free regimens can be selected based on age, comorbidities, IGHV status, and cytogenetic abnormalities to optimize treatment outcomes while considering different response spectra. It was found that the CR rate (CRR) in patients receiving obinutuzumab (G)
- |||||||||| Columvi (glofitamab-gxbm) / Roche
P1/2 data, Journal: Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study. (Pubmed Central) - Oct 4, 2024
P1/2
In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab. Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Rituxan (rituximab) / Roche
Review, Journal, IO biomarker: The role of antibody-based therapies in treating relapsed chronic lymphocytic leukemia. (Pubmed Central) - Oct 4, 2024
While immunotherapy is generally effective, some treatment failure can occur due to antigen loss, mutation, or down-regulation, and this remains the main obstacle to cure. The development of novel antibody therapies, including their combinations with targeted drugs and bispecific antibodies might help to reduce toxicity and improve efficacy.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Tecentriq (atezolizumab) / Roche
P2 data, Journal: Atezolizumab, venetoclax, and obinutuzumab combination in Richter transformation diffuse large B-cell lymphoma (MOLTO): a multicentre, single-arm, phase 2 trial. (Pubmed Central) - Oct 3, 2024
P2
The development of novel antibody therapies, including their combinations with targeted drugs and bispecific antibodies might help to reduce toxicity and improve efficacy. The atezolizumab, venetoclax, and obinutuzumab triplet combination was shown to be active and safe, suggesting that this chemotherapy-free regimen could become a new first-line treatment approach in patients with DLBCL-RT.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Oct 1, 2024
P1, N=121, Recruiting,
The atezolizumab, venetoclax, and obinutuzumab triplet combination was shown to be active and safe, suggesting that this chemotherapy-free regimen could become a new first-line treatment approach in patients with DLBCL-RT. Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026
- |||||||||| Brukinsa (zanubrutinib) / BeiGene
Enrollment change, Trial completion date, Trial primary completion date: ARIADNE: Zanubrutinib in Patients With Waldenstr (clinicaltrials.gov) - Oct 1, 2024
P=N/A, N=605, Recruiting,
Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Mar 2027 --> Jul 2026 N=400 --> 605 | Trial completion date: Apr 2027 --> Aug 2028 | Trial primary completion date: Apr 2027 --> Aug 2028
- |||||||||| Review, Journal: Biologics in Systemic Lupus Erythematosus: Recent Evolutions and Benefits. (Pubmed Central) - Sep 29, 2024
These cases suggest the potential of combining obinutuzumab with daratumumab for the treatment of recurrent FSGS. Biotechnology progress enables targeted biologic therapies for SLE, reducing disease activity and improving patients' quality of life.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen
Reimbursement, US reimbursement, Journal, HEOR, Medicare, Real-world evidence, Real-world: Real-world comparison of health care costs of venetoclax-obinutuzumab vs Bruton's tyrosine kinase inhibitor use among US Medicare beneficiaries with chronic lymphocytic leukemia in the frontline setting. (Pubmed Central) - Sep 25, 2024
A similar decline in costs was not observed among those treated with BTKis. Our study highlights the substantial economic benefits of fixed-duration VEN-O relative to treat-to-progression therapies like BTKis in the first-line CLL setting.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: Acalabrutinib in Combination with Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Sep 23, 2024
P2, N=52, Recruiting,
Our study highlights the substantial economic benefits of fixed-duration VEN-O relative to treat-to-progression therapies like BTKis in the first-line CLL setting. Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| Darzalex (daratumumab) / J&J
Refractory Primary Podocytopathy: Any Role for Daratumumab? (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_4343;
Guidelines recommend high-dose steroids as first-line the treatment for primary FSGS and MCD...Further randomized control trials of patient with multi-drug resistant primary podocytopathy are needed to determine the efficacy of daratumumab. Clinical course and treatment
- |||||||||| Darzalex (daratumumab) / J&J
Daratumumab for Anti-CD20-Refractory Membranous Nephropathy (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1725;
He was treated with tacrolimus followed by obinutuzumab (OBI) 1gx2...Plasma cell-directed agents like bortezomib or DARA, first approved for B cell malignancies, are now being investigated for autoimmune disease...DARA was able to achieve rapid serologic remission and reversal of his Cr trend, suggesting that anti-CD38 therapy holds promise for multidrug-resistant MN. Clinical course
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Obinutuzumab for Treatment of Refractory Lupus Nephritis (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1686;
Obinutuzumab therapy along with MMF, HCQ and ACE-i was associated with significant improvement in proteinuria, serum albumin and serum C4 levels in patients with refractory LN. Obinutuzumab could be considered as a treatment option for refractory LN.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Obinutuzumab in Children with Kidney Diseases: A Single-Center Experience (Exhibit Hall, Convention Center) - Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1671;
We noted significant reduction in proteinuria and 33% improvement in eGFR. All patients were able to be weaned off the steroids, 75% had complete remission and 24% were off all medications.
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