Legend Biotech(US:LEGN) Globenewswire·2025-12-06 19:00Core Insights - Legend Biotech Corporation announced long-term clinical data for CARVYKTI, showing a median progression-free survival (mPFS) of 50.4 months in triple-class-exposed relapsed/refractory multiple myeloma patients after a single infusion, marking one of the longest PFS outcomes for BCMA-targeted CAR-T therapy in this population [1][8][12] Group 1: Clinical Data and Efficacy - The CARTITUDE-1 and CARTITUDE-4 studies demonstrated that patients treated with CARVYKTI earlier in their treatment journey exhibited stronger immune fitness and a more immunocompetent tumor microenvironment, correlating with longer PFS [3][4][12] - At a median follow-up of 33.6 months, patients with standard-risk cytogenetics in the CARVYKTI arm achieved a 30-month PFS rate of 71.0%, compared to 43.2% in the standard-of-care arm [7][8] - Notably, all patients who achieved minimal residual disease (MRD)-negative complete response at 12 months following CARVYKTI infusion remained progression-free at 30 months [9] Group 2: Safety and Adverse Events - Among patients receiving CARVYKTI, cytokine release syndrome (CRS) occurred in 84% of cases, with a median time to onset of 7 days and resolution in 82% of patients [20][22] - Neurologic toxicities, including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), occurred in 24% of patients, with a median time to onset of 10 days [25][28] - Hypogammaglobulinemia was reported in 36% of patients, with 93% experiencing laboratory IgG levels below 500 mg/dL after infusion [52][53] Group 3: Company Overview and Future Directions - Legend Biotech is a leader in cell therapy, particularly with CARVYKTI, which has been approved for treating relapsed or refractory multiple myeloma [64][65] - The company is focused on expanding patient access and therapeutic potential of CARVYKTI while driving innovation across its pipeline of cell therapy modalities [71]