Lynozyfic (linvoseltamab) / Regeneron, Sanofi 
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  • ||||||||||  Lynozyfic (linvoseltamab) / Regeneron, Sanofi
    Review, Journal:  An evaluation of linvoseltamab for treatment of relapsed/refractory multiple myeloma. (Pubmed Central) -  Mar 12, 2025   
    Linvoseltamab has a similar efficacy profile with favorable CRS incidence and time-to-onset compared to other approved bispecific antibodies. Pending final regulatory approval and labeling, further real-world analyses are needed to evaluate its final role in the evolving landscape of T cell redirection therapy for MM.
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron, Sanofi
    Comparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups Analysis () -  Dec 7, 2024 - Abstract #ASH2024ASH_9044;    
    P1/2
    After adjustment, ORR was significantly higher in patients who received linvoseltamab compared with patients in the ECA (69.5% vs 45.7%, odds ratio [OR] 2.5 [95% confidence interval (CI) 1.6-4.1]) and in key subgroups with age 65-74 years (76.9% vs 48.3%, OR 3.6 [1.6-8.6]), age ?75 years (72.4% vs 48.5%, OR 2.8 [1.1-7.4]), Black or African American race (82.4% vs 25.0%, OR 14.0 [3.0-85.4]), White race (68.9% vs 49.7%, OR 2.2 [1.3-4.0]), standard cytogenetic risk (72.3% vs 51.3%, OR 2.5 [1.3-4.8]), ISS stage III (58.8% vs 19.7%, OR 5.8 [1.5-25.2]), absence of EMP (71.6% vs 49.3%, OR 2.6 [1.5-4.6]), triple-class refractory status (68.2% vs 45.7%, OR 2.6 [1.5-4.4]), quadruple-class refractory status (66.7% vs 45.9%, OR 2.4 [1.3-4.3]), 4-5 prior LOTs (65.1% vs 40.4%, OR 2.8 [1.3-6.0]), and >5 prior LOTs (75.7% vs 36.1%, OR 5.5 [2.4-13.6]).Numerically higher (not statistically significant) or similar ORR was observed for patients receiving linvoseltamab compared with patients in the ECA with age <65 years (59.5% vs 46.8%, OR 1.7 [0.79-3.6]), high-risk cytogenetics (65.0% vs 63.1%, OR 1.1 [0.41-2.9]), ISS stage I (73.3% vs 64.6%, OR 1.5 [0.62-3.7]), ISS stage II (67.6% vs 53.5%, OR 1.8 [0.72-4.7]), presence of EMP (58.8% vs 56.9%, OR 1.1 [0.32-3.8]), penta-class refractory status (64.3% vs 48.5%, OR 1.9 [0.78-4.8]), BMPC <50% (77.0% vs 67.2%, OR 1.6 [0.61-4.3]), BMPC ?50% (41.7% vs 36.0%, OR 1.3 [0.36-4.7]), and ?3 prior LOTs (68.0% vs 66.4%, OR 1.1 [0.43-2.9]). Separate findings will be presented for IMF-IMWG and COTA/GRN data at the congress.ConclusionsLinvoseltamab induced better ORR vs RW SOC treatments overall, and better or similar ORR in the key subgroups assessed, highlighting its therapeutic value across a range of patients with RRMM with heterogeneous risk profiles and levels of disease burden.
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron, Sanofi
    Soluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in Linker-MM1 (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5508;    
    P1/2
    IMS 2023), linvoseltamab treatment resulted in a high ORR across BL sBCMA concentrations, with greater response rates in patients with lower sBCMA concentrations and with the 200 mg dose. sBCMA concentrations rapidly decreased upon linvoseltamab treatment and normalized as patients achieved a deeper response, consistent with sBCMA being a marker of disease burden in MM, with greater reductions observed in responders vs non?responders.
  • ||||||||||  A CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-Engager (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5387;    
    In RRMM, linvoseltamab activates T cells by engaging the T cell receptor (TCR)/CD3 complex in the presence of BCMA-expressing MM tumor cells leading to tumor cell killing...CD28-targeting bsAbs, including REGN5668 (MUC16xCD28) and REGN5837 (CD22xCD28), are an emerging class of therapeutics capable of providing targeted costimulation and enhancing T cell effector function in combination with CD3-targeted bsAbs...Based on these promising preclinical results, a Phase 1 clinical trial is planned to evaluate the safety, tolerability, and preliminary efficacy of the CD38xCD28 bsAb REGN7945 and the BCMAxCD3 bsAb linvoseltamab in patients with RRMM. This innovative approach, leveraging the combinatorial potential of CD38xCD28 costimulation with linvoseltamab's targeted cytolytic activity, represents a novel therapeutic strategy with the potential to improve RRMM treatment outcomes.
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron, Sanofi
    Characterization of Linvoseltamab (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5369;    
    This study identified a unique binding orientation for linvoseltamab and demonstrated that linvoseltamab retains its binding and functional activity even in the presence of an identified BCMA mutation (R27P) that negatively impacts other BCMAxCD3 bispecific antibodies. This suggests that linvoseltamab may be less susceptible to resistance mechanisms that involve these mutations, resulting in improved patient outcomes.
  • ||||||||||  MODULE 4: Bispecific Antibodies for the Treatment of MM (Manchester Grand Hyatt San Diego, Seaport Ballroom EFGH; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_245;    
    No abstract available This program is supported by educational grants from GSK, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC and Karyopharm Therapeutics.Available efficacy and safety findings leading to the FDA approvals of the BCMA-directed bispecific antibodies teclistamab and elranatamab for R/R MM; optimal incorporation into management algorithms Efficacy and safety documented with investigational anti-BCMA bispecific antibodies for pretreated MM, such as linvoseltamab and alnuctamab Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab and cevostamab Recent FDA approval and optimal incorporation of talquetamab into disease management Spectrum, incidence and severity of CRS and other toxicities with various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies, including other bispecific antibody platforms, for MM
  • ||||||||||  Lynozyfic (linvoseltamab) / Regeneron, Sanofi
    Enrollment open, Minimal residual disease:  IMMUNOPLANT for Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=28, Recruiting, 
    This program is supported by educational grants from GSK, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC and Karyopharm Therapeutics.Available efficacy and safety findings leading to the FDA approvals of the BCMA-directed bispecific antibodies teclistamab and elranatamab for R/R MM; optimal incorporation into management algorithms Efficacy and safety documented with investigational anti-BCMA bispecific antibodies for pretreated MM, such as linvoseltamab and alnuctamab Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab and cevostamab Recent FDA approval and optimal incorporation of talquetamab into disease management Spectrum, incidence and severity of CRS and other toxicities with various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies, including other bispecific antibody platforms, for MM Not yet recruiting --> Recruiting
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron, Sanofi
    Journal:  Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. (Pubmed Central) -  Jul 29, 2024   
    Not yet recruiting --> Recruiting Linvoseltamab 200 mg induced deep and durable responses, with a median DOR of 29.4 months, in patients with RRMM with an acceptable safety profile.
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron, Sanofi
    Assessment of health-related quality of life (HRQoL) in triple-class () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_4593;    
    P1/2
    Over 76 weeks of treatment, improvements in measures of HRQoL including pain and fatigue were reported in patients with triple-class exposed RRMM receiving linvoseltamab; responders showed significant improvements on all scales. These PRO results support a favorable benefit
  • ||||||||||  Lynozyfic (linvoseltamab) / Regeneron, Sanofi
    New P2 trial, Minimal residual disease:  IMMUNOPLANT for Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) -  Apr 18, 2024   
    P2,  N=28, Not yet recruiting, 
  • ||||||||||  Journal:  Antibodies to watch in 2024. (Pubmed Central) -  Jan 9, 2024   
    In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
  • ||||||||||  Lynozyfic (linvoseltamab) / Regeneron, Sanofi
    Enrollment open, Trial completion date, Trial primary completion date:  LINKER-MM1: Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Dec 14, 2023   
    P1/2,  N=387, Recruiting, 
    Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful. Active, not recruiting --> Recruiting | Trial completion date: Mar 2032 --> Jun 2032 | Trial primary completion date: Jun 2023 --> May 2032
  • ||||||||||  Pooled Analysis on Bispecific Antibody-Related Toxicities in Multiple Myeloma (Halls G-H (San Diego Convention Center)) -  Nov 3, 2023 - Abstract #ASH2023ASH_2383;    
    Our results showed that non-BCMA bsAb were associated less hematotoxicity (combined grade 3-4 events and hypogammaglobulinemia), whereas BCMA bsAb were associated with less CRS rates. This is important information for treatment selection and mitigation strategy development aiming to optimize patient outcomes.
  • ||||||||||  MODULE 4: Bispecific Antibodies in the Treatment of MM (Omni San Diego, Grand Ballroom (Level 2), 4) -  Sep 23, 2023 - Abstract #ASH2023ASH_274;    
    Supported by AbbVie Inc, GSK, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Karyopharm Therapeutics, Legend Biotech, Regeneron Pharmaceuticals Inc, and Sanofi. Similarities and differences in the cellular targets and mechanisms of action among bispecific antibodies for MM Antitumor activity observed with teclistamab in the Phase I/II MajesTEC-1 study leading to its recent FDA approval for R/R MM; optimal incorporation into the treatment paradigm Rate, depth and duration of response observed with elranatamab in the pivotal Phase II MagnetisMM-3 trial for patients with R/R MM; FDA approval and current clinical role Key findings with other promising anti-BCMA bispecific antibody constructions, such as alnuctamab, linvoseltamab and ABBV-383, for heavily pretreated MM Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab, cevostamab and RG6234; FDA approval of talquetamab for patients with R/R MM after at least 4 prior therapies Spectrum, incidence and severity of cytokine release syndrome and other toxicities with the various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies for MM
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron
    Efficacy and safety of linvoseltamab 200 mg in patients with relapsed/refractory multiple myeloma (RRMM): Analysis of the LINKER-MM1 study (In Person) -  Sep 10, 2023 - Abstract #IMW2023IMW_521;    
    P1/2
    Similarities and differences in the cellular targets and mechanisms of action among bispecific antibodies for MM Antitumor activity observed with teclistamab in the Phase I/II MajesTEC-1 study leading to its recent FDA approval for R/R MM; optimal incorporation into the treatment paradigm Rate, depth and duration of response observed with elranatamab in the pivotal Phase II MagnetisMM-3 trial for patients with R/R MM; FDA approval and current clinical role Key findings with other promising anti-BCMA bispecific antibody constructions, such as alnuctamab, linvoseltamab and ABBV-383, for heavily pretreated MM Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab, cevostamab and RG6234; FDA approval of talquetamab for patients with R/R MM after at least 4 prior therapies Spectrum, incidence and severity of cytokine release syndrome and other toxicities with the various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies for MM In pts who had prior BCMA-targeted therapy exposure with belantamab mafodotin (n=10), ORR was 60%...CRS onset usually occurred on the day of dosing (median [range] time to first CRS onset from most recent dose, 14.8 h [0
  • ||||||||||  linvoseltamab (REGN5458) / Regeneron
    Trial in Progress: Linvoseltamab, a BCMAxCD3 bispecific antibody, in a Phase 1b multi-cohort study of combination regimens for patients with relapsed/refractory multiple myeloma (Trianti Upper Foyer; In Person) -  Sep 10, 2023 - Abstract #IMW2023IMW_319;    
    P1/2, P1b
    LINKER-MM2 (NCT05137054) is a global, Phase 1b, open-label, multi-cohort study designed to assess the safety, tolerability, and efficacy of linvoseltamab in combination with nine different agents (daratumumab, carfilzomib, lenalidomide, bortezomib, pomalidomide, isatuximab, fianlimab, cemiplimab, or nirogacestat) in separate cohorts of participants with RRMM. Analyses from the LINKER-MM2 study will provide important information on the tolerability and preliminary clinical efficacy of linvoseltamab when given in combination with other cancer therapies, aiming to improve care for patients with RRMM.