July 2,Johnson & JohnsonAnnouncementCilta-cel(cilta-cel, Trade Name:Carvykti) TreatmentRecurrence orLenalidomideRefractory Multiple MyelomaPhase III CARTITUDE-4 Study Met Secondary Endpoint of Overall Survival (OS) in the Pre-specified Second Interim Analysis.This study is a global, randomized, open-label clinical trial that evaluatedCarvykti ComparisonPVd Regimen (Pomalidomide+Bortezomib+Dexamethasone) or DPd regimen (Daratumumab+Pomalidomide+Dexamethasone) TreatmentPreviously received one to three lines of treatment (including proteasome inhibitors and immunomodulatory agents)Efficacy and safety in adult patients with relapsed or lenalidomide-refractory multiple myeloma. The primary endpoint of the study was progression-free survival (PFS), with one of the secondary endpoints being OS.The primary endpoint of the study was reached in January 2023, andCarvykti has been approved by the FDA for second-line treatment based on this result in April this year.Relapsed or Lenalidomide-RefractoryMultiple Myeloma.
The results of the second interim analysis of this update showed that, compared with the standard treatment (PVd or DPd) group,Carvykti GroupThe OS of patients was significantly prolonged with both statistical and clinical significance. Detailed results will be announced at an upcoming medical conference and submitted to regulatory authorities.CarvyktiIt is a CAR-T therapy targeting B-cell maturation antigen (BCMA), which modifies the patient's own T cells using genetically engineered chimeric antigen receptors (CAR) to recognize and eliminate BCMA-expressing cells. BCMA is primarily expressed on the surface of malignant multiple myeloma B cell lineage, late-stage B cells, and plasma cells.CarvyktiThe CAR protein has two targeting BCMA single-domain antibodies, which have high affinity for cells expressing BCMA. After binding to cells expressing BCMA, the CAR can promote T-cell activation and expansion, subsequently eliminating target cells.In December 2017, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (now Johnson & Johnson Innovative Medicine), andLegend BiotechSigned a global exclusive license and cooperation agreement to develop and commercialize Cilta-cel. In February 2022,CarvyktiApproved by the FDA for marketing, used to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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