Teclistamab majestec-1
WebNov 23, 2024 · Introduction: Teclistamab (JNJ-64007957) is a T-cell redirecting, bispecific IgG4 antibody that targets both B-cell maturation antigen (BCMA) and CD3 receptors to … WebOct 28, 2024 · The phase 1/2 MajesTEC-1 trial (NCT03145181; NCT04557098) of teclistamab-cqyv (Tecvayli) demonstrated high rates of deep and durable responses in patients with triple-class-exposed relapsed/refractory (R/R) multiple myeloma, leading to FDA approval of the agent. In the single-arm, open-label, multicenter MajesTEC-1 trial, …
Teclistamab majestec-1
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WebDec 13, 2024 · The primary objective of the MajesTEC-1 Phase 2 study (NCT04557098) was to evaluate the efficacy of teclistamab at the RP2D, established at SC 1.5 mg/kg … WebBackground: Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, demonstrated an overall response rate of 63.0% in 165 heavily pretreated patients with relapsed or refractory multiple myeloma in the phase 1/2 MajesTEC-1 study. Cytokine release syndrome (CRS), a known manifestation of T-cell redirection, was observed in …
WebNov 10, 2024 · The tolerability profile of teclistamab after ≈ 9 months of follow up in MajesTEC-1 was consistent with earlier analyses, and no new safety signals were seen . Immunogenicity was assessed in 238 patients from MajesTEC-1; one patient (0.4%) developed low-titre neutralizing antibodies to teclistamab treatment . WebJun 2, 2024 · Expert perspectives on the MajesTEC-1 trial, a study of BCMA- and CD3-targeted agent teclistamab in relapsed/refractory multiple myeloma. EP: 1. Patient …
WebAug 11, 2024 · Teclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and … WebOct 25, 2024 · The pivotal Phase 2 MajesTEC-1 clinical trial included patients who had received a median of five prior lines of therapy (n=110). 1 An overall response rate (ORR) ... TECVAYLI™ is supplied as 30mg/3mL and 153mg/1.7mL single-dose vials. 1 “In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated ...
Web160 Teclistamab in Combination with Subcutaneous Daratumumab and Lenalidomide in Patients with Multiple ... Emma Searle 1 *, Hang Quach 2, Sandy W. Wong, MD ... early disease control through the addition of tec. These data warrant further investigation. The randomized phase 3 MajesTEC-7 study will compare tec-dara-len vs the combination of …
WebSep 29, 2024 · The approval, based on the results of the MajesTEC-1 trial, is for adults with multiple myeloma that has come back after at least four prior lines of treatment. Further details on the MajesTEC-1 trial are discussed in the story below. ... Teclistamab is known as a bispecific antibody, meaning it can bind to two different targets at the same ... christian bernard watches wikiWebJun 8, 2024 · In the 2-part, open-label, first-in-human phase 1 MajesTEC-1 trial (NCT03145181), teclistamab was administered across 4 dosing cohorts, of which subcutaneous teclistamab 1500 µg/kg once weekly was identified as the recommended dose (RP2D), with step-up doses of 60 µg/kg and 300 µg/kg used to mitigate the risk for … christian berner oyWebNov 15, 2024 · Introduction: Teclistamab is an off-the-shelf, B-cell maturation antigen (BCMA) bispecific IgG4 antibody that redirects CD3+ T cells to mediate T-cell activation and subsequent lysis of BCMA-expressing myeloma cells. The multicohort, open-label, phase 1/2 MajesTEC-1 study is investigating safety/efficacy of teclistamab in patients with … george michael top songs everything she wantsWebJun 2, 2024 · 8036 Background: Teclistamab is a B-cell maturation antigen × CD3 bispecific antibody currently being evaluated in MajesTEC-1 (NCT04557098), an open-label, single-arm, phase 1/2 trial in patients with RRMM who had received ≥3 prior lines of therapy (LOT) and were TCE to an immunomodulatory agent, a proteasome inhibitor, and an anti … christian bernard vintage watchesWebBackground: Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, demonstrated an overall response rate of 63.0% in 165 heavily pretreated patients with … christian bernard watch pricesWebJun 13, 2024 · In the phase I/II MajesTEC-1 trial presented at the 2024 ASCO Annual Meeting (Abstract 8007) and simultaneously published in The New England Journal of Medicine, Philippe Moreau, MD, and colleagues found that the bispecific antibody teclistamab produced responses in nearly two-thirds of patients with relapsed or … george michael tributeWebDec 29, 2024 · “We look forward to working with the FDA in their review of our teclistamab submission.” The BLA submission for teclistamab is supported by data from MajesTEC-1 (NCT04557098, NCT03145181), an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with R/R multiple myeloma. In the study ... george michael tribute act dublin