Lunsumio (mosunetuzumab-axgb) / Roche 
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 5 Diseases   9 Trials   9 Trials   228 News 


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  • ||||||||||  lenalidomide / Generic mfg., Lunsumio (mosunetuzumab-axgb) / Roche
    Review, Journal:  SOHO State of the Art Updates and Next Questions | Novel Immunotherapy Combinations for the Treatment of Indolent B-Cell Lymphoma. (Pubmed Central) -  Feb 27, 2025   
    While lenalidomide-based immunotherapy remains the standard of care for relapsed iNHL, its frontline use is limited, due to nonsuperiority as compared to CIT...We also summarize the activity in iNHL of agents targeting antigens other than CD20 (including CD19 and CD79b), and novel immunotherapies and cellular therapies (including NK-cell based treatments). The therapeutic landscape of iNHL is soon to significantly change.
  • ||||||||||  Review, Journal:  Antibody Therapy for Patients with Lymphoid Malignancies: Past and Present. (Pubmed Central) -  Feb 26, 2025   
    We describe the indications for rituximab, obinutuzumab, ADCs, and bispecific antibody therapies. Finally, we summarize early data from ongoing trials on emerging novel therapy combination regimens and discuss the role of machine learning in future therapy development.
  • ||||||||||  Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Epkinly (epcoritamab-bysp) / Genmab, AbbVie
    Review, Journal:  The Development and Application of Bispecific Antibodies in B-Cell Non-Hodgkin Lymphoma. (Pubmed Central) -  Feb 25, 2025   
    BsAbs are now being evaluated in combination with other anti-lymphoma agents and in earlier lines of treatment, and the results of ongoing clinical trials involving these agents have the potential to reshape the treatment landscape for B-NHL. In this review, we describe the structural features, clinical data, and toxicity profile associated with the BsAbs currently used to treat B-NHL and then discuss ongoing studies and future directions for this exciting new class of therapeutic agents.
  • ||||||||||  Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
    Trial completion date, Trial primary completion date:  UPCC 48420: CAR-T Followed by Bispecific Antibodies (clinicaltrials.gov) -  Feb 12, 2025   
    P2,  N=42, Recruiting, 
    Trial registration: www.clinicaltrials.gov (NCT02500407). Trial completion date: Dec 2025 --> Jun 2027 | Trial primary completion date: Dec 2024 --> Jun 2026
  • ||||||||||  Journal:  New bispecific antibodies in diffuse large B-cell lymphoma. (Pubmed Central) -  Feb 6, 2025   
    We also consider emerging understandings of resistance mechanisms. Finally, we review key ongoing trials and combinations and consider the potential future of bispecific antibodies within the sequence of available treatments for DLBCL.
  • ||||||||||  Lunsumio (mosunetuzumab-axgb) / Roche
    Review, Journal, CAR T-Cell Therapy:  Sequencing bispecific antibodies and CAR T cells for FL. (Pubmed Central) -  Dec 7, 2024   
    We generally prioritize CAR T before BsAbs for patients with proven or suspected HT given the curative-potential of this approach based on trial data from R/R diffuse large B-cell lymphoma; it is unknown whether BsAbs offer the same long-term benefit in transformed FL. Overall, with the ability to personalize the sequencing of BsAbs and CAR T, the recently expanding portfolio of highly effective immunotherapies for R/R FL is poised to offer considerable benefit to this patient population.
  • ||||||||||  Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Epkinly (epcoritamab-bysp) / Genmab, AbbVie
    Impact of Absolute Lymphocyte Count on Efficacy and Toxicity of T-Cell Engagers in Non-Hodgkin's Lymphoma () -  Dec 7, 2024 - Abstract #ASH2024ASH_9768;    
    This differs from the information currently known about ALC and CAR-T therapy and should be confirmed with a larger patient population. If confirmed in larger, multi-institution or in head-to-head studies, this could shift the treatment paradigm in favor of TCEs over CAR-T in patients with low ALC.
  • ||||||||||  Estimation of Eligibility and Response to Bispecific Antibody Therapy in US Patients with Lymphoma and Multiple Myeloma () -  Dec 7, 2024 - Abstract #ASH2024ASH_9653;    
    Excluding blinatumomab, all have gained accelerated approval through phase II trials to treat relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL); primarily diffuse large B-cell lymphoma (DLBCL and follicular lymphoma (FL), and R/R multiple myeloma (MM)...The calculated number of people eligible was multiplied by the overall response rate (ORR) reported in the trial that led to the bsAb approval for each year a therapy had an approval, using the highest calculated response, to estimate the population who would potentially benefit of these therapies.ResultsSix bsAbs were approved in the US since 2022 to treat NLH and MM : epcoritamab and glofitamab in 2023 to treat R/R DLBCL and other mature B-cell neoplasms, mosunetuzumab in 2022 and epcoritamab in 2024 to treat R/R grade 1-3A FL, and for MM, teclistamab in 2022, and elranatamab and talquetamab in 2023...Based on best available response rates from registration trials, we estimated that 9.6% and 10.5% newly diagnosed NHL and MM patients, respectively, would potentially benefit from bsAbs.ConclusionsEven though CR and ORR of bsAbs are high for highly pretreated patients, we found the percentage of newly diagnosed NHL and MM patients who would become potentially eligible and would respond to these therapies to be quite low (approximately only 1 out of 10). Even though these conclusions are driven by best-case scenario assumptions and have a risk of bias, they provide insights of the actual impact and reach of these newer therapies.
  • ||||||||||  Future Landscapes of Bispecific Antibodies in Chronic Lymphocytic Leukemia (CLL). Systematic Review of Ongoing Trials () -  Dec 7, 2024 - Abstract #ASH2024ASH_8839;    
    The bispecific antibodies under investigation include Epcoritamab (4 trials), Mosunetuzumab (3 trials), and Plamotumab, Glofitamab, and GEN3009 (one trial each)...The trials primarily explore bispecific antibodies as third-line therapy in 5(50%) of the trials and as second-line therapy in 4(40%) of the trials, with Venetoclax being the most common combination therapy used...The diverse geographic distribution and variety of bispecific antibodies under investigation underscore the global effort to advance CLL treatment. The focus on safety and tolerability ensures that these new therapies will be effective and manageable for patients, paving the way for improved outcomes in this challenging disease.
  • ||||||||||  Lunsumio (mosunetuzumab-axgb) / Roche
    Efficacy and Safety Outcomes of CAR T-Cell Therapies in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Who Received Prior Treatment with Mosunetuzumab () -  Dec 7, 2024 - Abstract #ASH2024ASH_8598;    
    P1/2
    Two (18.2%) patients received bendamustine within 12 months prior to administration of CAR T-cell therapy...The CAR T-cell therapies received were an investigational CD19-targeted CAR T-cell therapy (n=4), axicabtagene ciloleucel (n=3), brexucabtagene autoleucel (n=2), and tisagenlecleucel (n=2).As of July 12, 2024, in patients with indolent B-NHL, the BOR rate with CAR T-cell therapy was 100% (6/6), with 3 (50.0%) patients achieving a CR; duration of response (DOR) ranged from 3.4 to 59.3 months, with 4 responses ongoing...These results suggest that CAR T-cell therapy is a good treatment option post mosunetuzumab for patients with R/R B-NHL; however, larger studies are needed to fully characterize the efficacy and safety of CAR T-cell therapy after mosunetuzumab. Additional patient data, including from other institutions, will be presented.
  • ||||||||||  Cytokine Release Syndrome: Trends with T Cell Engaging Bispecifics from a Systematic Review of Licensing Applications () -  Dec 7, 2024 - Abstract #ASH2024ASH_7878;    
    Mosunetuzumab and elranatamab had the lowest CRS risk among TCEs for non-hodgkin's lymphoma (NHL) (range 39-70%) and multiple myeloma (MM) (range 58-79%), respectively...All TCEs employed a 2 step priming approach, except blinatumomab (1 step; continuous infusion) and talquetamab bi-weekly (3 step), and were successful at mitigating CRS beyond the first full dose...Covariates associated with CRS included baseline factors (disease status, treatment history, target level, effector cell status, age) and on-treatment factors (tocilizumab use, prior Cmax)...Thus, further characterizing CRS and establishing a link between drug levels, biomarkers, and clinical events will not only aid TCE development but also benefit patients by reducing the need for intensive clinical interventions and hospitalization. Quantitative clinical pharmacology methods including mechanism- and empirical-based approaches will continue to be instrumental in TCE development, especially as regimens become more complex with combination and pretreatment integration.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Lunsumio (mosunetuzumab-axgb) / Roche, Yescarta (axicabtagene ciloleucel) / Gilead
    Review, Journal, CAR T-Cell Therapy, IO biomarker:  Comparative Analysis of Bispecific Antibodies and CAR T-Cell Therapy in Follicular Lymphoma. (Pubmed Central) -  Dec 3, 2024   
    Among BsAbs, mosunetuzumab showed promise in the GO29781 trial, with a 62% overall response rate in heavily pretreated RR-FL patients...Cost-effectiveness considerations are essential; while CAR-T therapies incur higher initial costs, their potential for long-term remission may mitigate expenses associated with repeated treatments or hospitalizations. Future research into resistance mechanisms and optimal therapeutic sequencing will further refine RR-FL management strategies.
  • ||||||||||  Lunsumio (mosunetuzumab-axgb) / Roche, Zynlonta (loncastuximab tesirine-lpyl) / Overland ADCT BioPharma
    A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 21, 2024 - Abstract #ASH2024ASH_7164;    
    P2
    Exploratory objective is to evaluate the tumor immune microenvironment (TME) and biomarkers of response to Lonca/Mosun. We will explore whether the response to Lonca/Mosun is associated with features of the TME, including density of and/or spatial relationships between immune cell populations, level of expression of CD19 and CD20, and genetic mutations particularly in immune-related genes.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
    Revealing the Synergistic Potential of Mosunetuzumab Plus Polatuzumab Vedotin through CD20 Upregulation (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5225;    
    Overall, this review offers a real-world view of CRS/ICANS incidence, as well as resource utilization that supports the safety and feasibility of outpatient administration. Background Despite the development of effective therapies for aggressive non-Hodgkin lymphoma, such as polatuzumab vedotin (Pola) in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP), approximately 20
  • ||||||||||  EVOLVE-205 / EvolveImmune Therap
    EVOLVE205, a Highly Potent 2:1 CD20-Targeted CD2 Co-Stimulatory T Cell Engager Engineered for the Treatment of B Cell Malignancies and B Cell Autoimmune Diseases (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5209;    
    Introduction : T cell engager (TCE) CD3-bispecifics have improved the treatment of patients with B cell lymphomas leading to recent approvals of the CD20-targeted CD3 bispecifics Glofitamab, Mosunetuzumab, and Epcoritamab for patients with relapsed, refractory diseases...Importantly, in a B-cell depleted PBMC-HT tumor co-culture assay, the tumor-killing potency of EVOLVE205 was improved by up to 60-fold compared to Glofitamab and Epcoritamab, and by over 1,000-fold compared to B-cell depleting therapeutics (BCDTs) such as Rituximab...Conclusion : CD20-targeted EVOLVE205 utilizes integrated CD2 costimulation to potently induce T cell activation and tumor killing without mediating significant cytokine release, and demonstrates significant in vivo efficacy, IgG-like pharmacokinetics, and a favorable developability profile. These features of EVOLVE205 appear to offer efficacy and safety advantages compared to clinically available CD20-targeted TCE therapies and BCDTs for the treatment of B cell lymphomas and for B cell-mediated autoimmune diseases.
  • ||||||||||  LY4152199 / Eli Lilly
    LY4152199, a First-in-Class BAFF-RxCD3 Bispecific Antibody for the Treatment of B Cell Malignancies (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5204;    
    Taken together, LY4152199 exhibits specificity, desirable functional activity and good developability. It has demonstrated the potential as a first-in-class BAFF-RxCD3 bispecific antibody to treat BAFF-R-positive B cell malignancies, including relapsed or refractory cases with CD19/CD20 expression loss.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
    Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5113;    
    Dexamethasone 20 mg is mandated before all C1 Mosun doses and optional thereafter...Conclusions : Analysis of Mosun plus Pola for frontline systemic treatment in high tumor burden FL demonstrates a high CR rate and toxicity profile aligning with prior studies. With 19 of the first 23 patients having achieved CR as best response, this phase 2 trial has met its prespecified primary endpoint, and this regimen appears encouraging for further study.