- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
A Cost-Effectiveness Analysis of Mosunetuzumab for Treatment of Third- or Higher-Line Relapsed or Refractory (R/R) Follicular Lymphoma (FL) in the United States (US) () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_2034;
P1/2
A three-state (progression-free, progression, death) partitioned-survival model was developed to simulate the lifetime costs and outcomes of Mosun against 7 comparators: axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), tazemetostat (taz, EZH2 wild-type only), rituximab in combination with lenalidomide (R-Len) or bendamustine (R-Benda), obinutuzumab in combination with bendamustine (O-Benda), and 3L+ FL treatments used in routine care by a retrospective real-world cohort (RW). Mosun is projected to be cost-effective compared with most approved regimens for the treatment of adults with 3L+ R/R FL.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Real-World Treatment Patterns and Overall Survival Among Follicular Lymphoma Patients: A SEER-Medicare Analysis () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_443;
Across different LOTs, the most used regimens were rituximab or obinutuzumab (R/O) + chemotherapy (61.3% in 1L, 52.4% in 2L, 52.7% in 3L) and R/O monotherapy (30.7% in 1L, 30.1% in 2L, 21.8% in 3L). This retrospective analysis showed that FL patients experience worsening survival outcomes as they progress through later LOTs, demonstrating the high unmet need of FL patients with relapsed/refractory disease.
- |||||||||| Clinical Advances in Lupus Nephritis - A New Age in Biologic Therapy (Convention Center: 201) - Mar 8, 2023 - Abstract #PAS2023PAS_864;
Topic/title: Do we really need cyclophosphamide?...Topic/title: Voclosporin and calcineurin inhibitors does it really improve outcomes in lupus nephritis?...Topic/title: Utility of Belimumab as a steroid sparing agent in lupus nephritis Objective: Discuss the role of Belimumab in lupus treatment and effect on reducing long term steroid exposure in lupus nephritis...Discuss recent clinical trials on B cell depleting agents such as Obinutuzumab, Rituximab/Obinutuzumab, and the potential for CAR T cell B cell depletion for lupus treatment...Recognize risks of agents used in treatment of lupus nephritis. Describe new therapeutic options for treatment of lupus nephritis.
- |||||||||| ST-067 / Simcha Therap, Keytruda (pembrolizumab) / Merck (MSD), Gazyva (obinutuzumab) / Roche, Biogen
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: KEYNOTE-E64: Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067 (clinicaltrials.gov) - Mar 6, 2023
P1a, N=198, Recruiting,
No abstract available Trial completion date: Jul 2023 --> Jan 2025 | Trial primary completion date: May 2023 --> Jun 2024
- |||||||||| Brukinsa (zanubrutinib) / BeiGene
Enrollment change: ARIADNE: Zanubrutinib in Patients With Waldenstr (clinicaltrials.gov) - Mar 2, 2023
P=N/A, N=300, Recruiting,
Trial completion date: Jul 2023 --> Jan 2025 | Trial primary completion date: May 2023 --> Jun 2024 N=150 --> 300
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date: CLL2-BAAG: Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL (clinicaltrials.gov) - Feb 23, 2023
P2, N=46, Active, not recruiting,
Trial completion date: Apr 2029 --> Nov 2029 | Trial primary completion date: Apr 2029 --> Nov 2029 Trial completion date: Aug 2023 --> May 2023
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment closed, Monotherapy: CLL17: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (clinicaltrials.gov) - Feb 23, 2023
P3, N=897, Active, not recruiting,
Trial completion date: Aug 2023 --> May 2023 Recruiting --> Active, not recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Metastases: GAZELLE: An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma (clinicaltrials.gov) - Feb 23, 2023
P4, N=114, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed, Trial completion date, Trial primary completion date, 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) - Feb 17, 2023
P1/2, N=860, Active, not recruiting,
Trial primary completion date: Oct 2022 --> Jun 2022 Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Aug 2025 | Trial primary completion date: Jun 2023 --> Aug 2025
- |||||||||| sonrotoclax (BGB-11417) / BeiGene
Trial completion date, Trial primary completion date: BGB-11417-101: Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies (clinicaltrials.gov) - Feb 8, 2023
P1a/1b, N=506, Recruiting,
Our study suggests that AChR autoantibodies are produced by nonmalignant, polyclonal B cells The new anti-CD20 treatment obinutuzumab might be considered in effectively treating AChR MG. Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
- |||||||||| 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, 2023
P2, N=30, Active, not recruiting,
Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025 Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Obinutuzumab Desensitization with a Twist () - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1539;
The patient was admitted to intensive care and premedicated 30 minutes prior to infusion with methylprednisolone 80mg IV, and acetaminophen 650mg PO, diphenhydramine 50mg PO, and famotidine 20mg PO...Reaction occurred 2 hours into infusion at a cumulative dose of approximately 0.42mg. Decision was made to avoid further treatment with this medication.
- |||||||||| 09- New therapies in SLE () - Feb 4, 2023 - Abstract #BSR2023BSR_32;
For example, in lupus nephritis treatment choice is increasingly dependent on specifics of the biopsy, and there are logical choices for biologic sequencing emerging based on the type of prior therapy failure. Aim To understand the theoretical basis and effective use of the range of new therapies for SLE Objective1 To understand the evidence and effective use of existing and emerging B cell and BAFF targeted therapies for SLE Objective2 To understand new therapeutic options in lupus nephritis and how to select appropriate therapy Objective3 To understand the rationale and role for type I interferon and other non-B cell targeted therapies in SLE
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Trial completion date, Trial primary completion date: Lenalidomide and Obinutuzumab in Treating Patients With Relapsed Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov) - Feb 2, 2023
P1/2, N=70, Completed,
This case highlights the potential of γδ T cells and the feasibility of this therapeutic approach for further clinical trials. Active, not recruiting --> Completed | Trial completion date: May 2022 --> Jan 2023 | Trial primary completion date: May 2022 --> Jan 2023
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Obinutuzumab Effectively Depletes Key B-cell Subsets in Blood and Tissue in End-stage Renal Disease Patients. (Pubmed Central) - Jan 27, 2023
This loss of B cells was associated with increased B cell-activating factor and decreased CXCL13 levels in circulation. Our data further characterize the mechanistic profile of obinutuzumab and suggest that it may elicit greater efficacy in indications such as lupus where B-cell targeting therapeutics are limited by the resistance of pathogenic tissue B cells to depletion.
- |||||||||| Review, Journal: Systemic lupus erythematosus. (Pubmed Central) - Jan 27, 2023
Additionally, as many susceptibility genes for SLE are associated with signal transduction of dendritic and B cells, cytokines and signaling molecules that bridge the innate and adaptive immune systems are the current focus of attention. Promising approaches include the development of a Janus kinase inhibitors targeting tyrosine kinase deucravacitinib, plasmacytoid dendritic cell-targeted drugs, proteasome inhibitors (e.g., iberdomide), type II anti-CD20 antibody, and obinutuzumab.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date, Adverse events, Combination therapy: Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - Jan 26, 2023
P2, N=20, Recruiting,
Promising approaches include the development of a Janus kinase inhibitors targeting tyrosine kinase deucravacitinib, plasmacytoid dendritic cell-targeted drugs, proteasome inhibitors (e.g., iberdomide), type II anti-CD20 antibody, and obinutuzumab. Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Sep 2025
- |||||||||| 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) - Jan 26, 2023
P1, N=47, Active, not recruiting,
Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Sep 2025 Trial completion date: Dec 2022 --> Sep 2023 | Trial primary completion date: Dec 2022 --> Sep 2023
- |||||||||| glofitamab (RG6026) / Roche
Glofitamab in Primary Mediastinal Large B-cell Lymphoma after CAR T-cell Treatment Failure (Poster Area) - Jan 24, 2023 - Abstract #EHAEBMTCART2023EHA_EBMT_CART_94;
Being a standard of care in r/r PMBCL, autologous HSCT was not performed due to inadequate response to multiple salvage regimens (DHAP, nivolunab-R-ICE, brentuximab vedotin, bendamustine, lenalidomide, nivolumab-gemcitabine-vinorelbine)...After pretreatment with 1000 mg of obinutuzumab, glofitamab was applied within Named Patient Program in a standard step-up dosing mode...Durable remission has lasted for eight months after HSCT.Treatment with glofitamab in r/r PMBCL after CAR T-cell therapy failure seems to be safe and effective. Glofitamab showed durable remission and paved the way to subsequent allogeneic HSCT in the heavily pretreated PMBCL patient.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Review, Journal, HEOR, Real-world evidence, Real-world: Real-world evidence on venetoclax in chronic lymphocytic leukemia: The Italian experience. (Pubmed Central) - Jan 22, 2023
Addition of rituximab to venetoclax produced more complete responses in patients with relapsed/refractory CLL, while higher disease burden and progression while receiving a prior Bruton's tyrosine kinase inhibitor were both associated with poorer outcomes in patients treated with venetoclax...No studies of venetoclax plus obinutuzumab for the first-line treatment of patients with CLL were available due to the short time since approval in Italy...Several cohorts addressed the impact of COVID-19 on patient management and outcomes, suggesting that treated patients and those in clinical observation had similar rates of COVID-19-related hospital admission, intensive care unit admission, and mortality. Overall, the responses and tolerance to venetoclax observed in the Italian real-world setting confirm the tolerability and effectiveness of venetoclax regimens in high-risk patients.
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies (clinicaltrials.gov) - Jan 18, 2023
P1, N=35, Active, not recruiting,
Overall, the responses and tolerance to venetoclax observed in the Italian real-world setting confirm the tolerability and effectiveness of venetoclax regimens in high-risk patients. Trial completion date: Oct 2022 --> Dec 2024 | Trial primary completion date: Oct 2022 --> Dec 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion: CLL2-GiVe: Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL (clinicaltrials.gov) - Jan 17, 2023
P2, N=41, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
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