- |||||||||| Columvi (glofitamab) / Roche, Lunsumio (mosunetuzumab) / Roche, Biogen, Epkinly (epcoritamab-bysp) / Genmab, AbbVie
303-A - Bispecifics in Lymphoma (Ballroom A) - Feb 27, 2024 - Abstract #HOPA2024HOPA_72; Session Description: A review of the literature, adverse effects and economic analysis for the 3 lymphoma bispecifics mosunetuzumab, epcoritamab and glofitamab. Learning Objectives:
- |||||||||| Review, Journal: Bispecific antibodies in indolent B-cell lymphomas. (Pubmed Central) - Jan 30, 2024
This article reviews contemporary data and ongoing studies evaluating the role of bispecific antibodies in indolent b-cell non Hodgkin lymphomas. This is an area of active research and presents many opportunities in advancing the treatment of indolent lymphomas and potentially forge a chemo-free treatment paradigm in this condition.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Dec 26, 2023 P1, N=30, Recruiting, This is an area of active research and presents many opportunities in advancing the treatment of indolent lymphomas and potentially forge a chemo-free treatment paradigm in this condition. Not yet recruiting --> Recruiting | Trial completion date: May 2025 --> Dec 2025 | Initiation date: Dec 2023 --> Sep 2024 | Trial primary completion date: May 2025 --> Dec 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Lunsumio (mosunetuzumab-axgb) / Roche
Enrollment change, Trial completion date, Trial primary completion date: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Dec 11, 2023 P1, N=137, Recruiting, Phase classification: P1b --> P1 N=56 --> 137 | Trial completion date: Jul 2027 --> Oct 2029 | Trial primary completion date: Feb 2026 --> May 2027
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Journal, HEOR, Real-world evidence, Real-world: Matching-adjusted indirect comparison from the Lymphoma Epidemiology of Outcomes Consortium for Real World Evidence (LEO CReWE) study to a clinical trial of mosunetuzumab in relapsed or refractory follicular lymphoma. (Pubmed Central) - Nov 30, 2023 Progression-free survival at 12 months was similar in the weighted LEO CReWE (60%, 95% CI:51-69%) and the mosunetuzumab trial (PFS 58%, 95% CI:47-68%). Sensitivity analyses examining the impact of matching variables, selection of line of therapy, and application of eligibility criteria, provide context for best practices in this setting.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Journal, IO biomarker: Alternative splicing of its 5' UTR limits CD20 mRNA translation and enables resistance to CD20-directed immunotherapies. (Pubmed Central) - Nov 17, 2023 To determine whether CD20 splicing is involved in immunotherapy resistance, we performed RNA-seq on four post-mosunetuzumab follicular lymphoma relapses and discovered that in two of them downregulation of CD20 was accompanied by the V3-to-V1 shift. Thus, splicing-mediated mechanisms of epitope loss extend to CD20-directed immunotherapies.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche
Enrollment closed, Phase classification: CO41942: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (clinicaltrials.gov) - Nov 14, 2023 P1/2, N=187, Active, not recruiting, Not yet recruiting --> Recruiting | Trial completion date: Mar 2026 --> Oct 2026 | Initiation date: Oct 2023 --> Jul 2024 | Trial primary completion date: Mar 2026 --> Oct 2026 Recruiting --> Active, not recruiting | Phase classification: P1 --> P1/2
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion: GO40515: A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Nov 9, 2023 P1/2, N=117, Completed, Recruiting --> Active, not recruiting | Phase classification: P1 --> P1/2 Active, not recruiting --> Completed
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen, Yescarta (axicabtagene ciloleucel) / Gilead
Cost-Effectiveness of Axicabtagene Ciloleucel Versus Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma in the US (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6551; P1/2, P2 Conclusions Axi-cel is cost-effective versus mosun in r/r 3L+ FL at an ICER of $84,016/QALY gained, which is far lower than the commonly-cited US willingness-to-pay threshold of $150,000/QALY. This analysis demonstrates the value of using axi-cel, reflecting the aggregate benefits of a one-time therapy, reduction in need for subsequent treatment lines, and population segment experiencing effective cure.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Infectious Complications in Patients with Relapsed or Refractory (R/R) Non-Hodgkin (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5843; P1/2 Viral infections were especially common, including respiratory infections and shingles episodes. Our findings highlight the need for careful monitoring and implementation of preventive strategies to decrease the infection burden in these vulnerable patients.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Early Complete Responses with Mosunetuzumab Monotherapy in Treatment-Na (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5837; Dexamethasone prophylaxis was administered through C2D1, and could be omitted after that for patients without CRS in the previous cycle...Pts with SD or PR could receive 6 cycles (21 day cycle, Part B) of polatuzumab vedotin and obinutuzumab, followed by an end of treatment (EOT) PET/CT...No pts required tocilizumab...Injection site reactions and headaches were common but reversible. Safety and efficacy has remained well within study suspension thresholds and accrual is ongoing to a goal of 42 total patients.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Marsun, a Phase III, Multicenter, Open Label, Randomized, Controlled Study Investigating Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients with Relapsed or Refractory Margin... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4013; Previous treatment lines must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (CHOP, bendamustine, CVP, chlorambucil) or targeted treatment such as ibrutinib...For each patient, investigator choice must be decided before randomization between R-Len (12 cycles) and R-chemotherapy (R-Bendamustine or R-CHOP followed by a 6 months maintenance)...The study will comprise a first stage of 10 patients in a safety cohort with mosunetuzumab-lenalidomide followed by a stage 2 with patients randomized 1:1 to receive M-len or investigator choice (125 patients per arm). The sponsor of the trial is the Lymphoma Academic Research Organisation (LYSARC) in collaboration with GLA and FIL with the support of F.Hoffmann-La Roche Ltd.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Baseline CD4 T Cells Are Associated with Improved Response to CD20-CD3 Bispecifics in Lymphoma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3961; P1/2 Background : Mosunetuzumab (Mosun) is a CD20xCD3 T-cell engaging bispecific monoclonal antibody that redirects T cells to eliminate malignant B cells...Conclusions : Baseline biomarker data reveal an important role for CD4 T cells in Mosun response and suggest that higher prevalence of CD4s may be a factor in the improved response to Mosun in indolent NHL. Our data specifically point to Tfh cells as potential drivers of response, although the mechanisms by which Tfh contributes to response, as well as the implications for other bispecifics, requires more exploration.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Novel CD20 Mutations As a Mechanism of Resistance to CD20-CD3 Targeted Therapies in Non-Hodgkin (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3756; Given the success of these targeted therapies, strategies to further enhance therapeutic activity are being explored, including the CD20-CD3 bispecific molecule, mosunetuzumab, which is approved for treatment of relapsed and refractory Follicular Lymphoma in adults who have received > 2 lines of treatment...[1] Schuster et al. Journal of Clinical Oncology 2022, 40 (16), 7526.
- |||||||||| Columvi (glofitamab) / Roche, Blincyto (blinatumomab) / Astellas, Amgen, Lunsumio (mosunetuzumab) / Roche, Biogen
Fine Tuning Bispecific Activity in CLL: Harmonizing a CD19/20-T Cell Bispecific with a CD28 or 4-1BBL Costimulatory Bispecific (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2492; Costimulatory bispecifics provide co-stimulation to T cells in cases of missing expression of costimulatory molecules on tumor cells as well as improving function of exhausted T cells. Clinical trials will be needed to assess the impact of combinatorial strategies to improve T-cell efficacy and to overcome resistance.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Alterations in Immune Cell Composition during First-Line Therapy with Mosunetuzumab for Follicular or Marginal Zone Lymphoma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2068; P2 Additional data from this trial will aid in understanding whether the persistent increase in PD1+CD8+ T-cells and expansion of Tregs are linked to a functionally exhausted phenotype and whether lenalidomide could potentially reverse it. Although our observation is limited by sample size, it can still provide insights into optimizing the administration schedules of BiAb therapy in future trials (e.g., intermittent vs.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Cost Effectiveness of Mosunetuzumab and CAR-T Cell Therapy in Relapsed/Refractory Follicular Lymphoma (Marriott Marquis - Marriott Grand) - Nov 3, 2023 - Abstract #ASH2023ASH_1286; Although our observation is limited by sample size, it can still provide insights into optimizing the administration schedules of BiAb therapy in future trials (e.g., intermittent vs. Background: T cell engaging therapies including mosunetuzumab (mosun), a CD20/CD3 bispecific antibody, and two CAR-T cell products
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche, Biogen
Enrollment open, Trial initiation date: MERLIN: Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries (clinicaltrials.gov) - Oct 31, 2023 P2, N=80, Recruiting, Background: T cell engaging therapies including mosunetuzumab (mosun), a CD20/CD3 bispecific antibody, and two CAR-T cell products Not yet recruiting --> Recruiting | Initiation date: Jun 2023 --> Sep 2023
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Journal: T cell-Dependent Bispecific Therapy Enhances Innate Immune Activation and Antibody-Mediated Killing. (Pubmed Central) - Oct 30, 2023 Here we show that treatment with mosunetuzumab in patients results in natural killer (NK) cell activation in the peripheral blood...Finally, we showed that TDB treatment enhanced the efficacy of Fc-driven killing to an orthogonal solid tumor target in vivo. These results provide rationale for novel antibody therapy combinations that take advantage of both adaptive and innate immune responses.
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Review, Journal: Mosunetuzumab and the emerging role of T-cell-engaging therapy in follicular lymphoma. (Pubmed Central) - Oct 30, 2023 T-cell-dependent bispecific antibodies, of which mosunetuzumab is the first to be approved for R/R FL, are proving to be a highly effective, 'off-the-shelf' option with manageable toxicities. This review covers approved treatments for R/R FL and focuses on preclinical and clinical data available for mosunetuzumab (Lunsumio
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab) / Roche, Biogen
A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Diffuse Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma. (Crystal A (Lobby Level, West Tower)) - Oct 28, 2023 - Abstract #SWOGFall2023SWOG_Fall_185; Summary Statement The study was activated on February 23, 2023. As of June 30, 2023, six participants had been registered, including four participants from Medical University of South Carolina, one from Providence Portland Medical Center, and one from University of Rochester.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche, Tazverik (tazemetostat) / Ipsen
Enrollment open: Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma (clinicaltrials.gov) - Oct 26, 2023 P2, N=50, Recruiting, As of June 30, 2023, six participants had been registered, including four participants from Medical University of South Carolina, one from Providence Portland Medical Center, and one from University of Rochester. Not yet recruiting --> Recruiting
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