Legend Biotech unveils five-year survival data fro CARVYKTI

Legend Biotech (LEGN) announced new long-term results from the CARTITUDE-1 study in heavily pretreated relapsed/refractory multiple myeloma patients. RRMM patients were treated with a single infusion of CARVYKTI with no maintenance or subsequent myeloma therapy. Notably, an unprecedented 33% of patients remained progression-free for five years or more.These data were featured in an oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting. To date, more than 6,500 patients have been treated with CARVYKTI, the first and only CAR T-cell treatment in multiple myeloma to show overall survival benefit vs. standard of care. In a subset of 12 patients from a single center from this analysis who underwent serial minimal residual disease assessments, all 12 patients remained progression-free greater than or equal to5 years, were MRD-negative and showed no disease on annual PET/CT scans for five years. At median follow-up of 61.3 months in CARTITUDE-1, patients treated with CARVYKTI demonstrated a median OS of 60.7 months. Thirty-two patients remained progression-free for greater than or equal to5 years after a single CARVYKTI infusion, with no further multiple myeloma treatment. These patients had a median age of 60 years, received a median of 6.5 prior lines of therapy, and included patients with high-risk cytogenetics, with extramedullary disease, triple-class refractory disease, and penta-drug refractory disease. Prior to enrollment, their median time to progression following the last line of therapy was four months. Safety signals were consistent with the known benefit/risk safety profile of CARVYKTI. No new movement or neurocognitive treatment-emergent adverse events/parkinsonism were reported. Two new cases of second primary malignancies were reported, both solid tumors. These data were also simultaneously published in the Journal of Clinical Oncology. In addition to the long-term survival data, the following updates were provided during poster presentations: CARTITUDE-4: Data from intent-to-treat high-risk subgroups show CARVYKTI improved progression-free survival and overall survival versus standard therapy. CARTITUDE-4 is a Phase 3 study evaluating CARVYKTI versus two standard of care therapies of pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, dexamethasone in patients with relapsed, lenalidomide-refractory multiple myeloma after one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. At median follow-up of 33.6 months, CARVYKTI demonstrated consistent and durable benefit in PFS and OS compared with SOC across high-risk subgroups, including cytogenetic risk groups, EMD status, and number of prior lines of therapy. In patients with EMD: Median PFS was 13 months with CARVYKTI versus 4 months with standard therapies. Median OS was not reached with CARVYKTI versus 16 months with standard therapies. By 1, 2, or 3 prior lines of therapy: In patients with one pLOT: Median PFS was NR with CARVYKTI versus 17 months with standard therapies; Median OS was NR with CARVYKTI versus NR with standard therapies. In patients with two pLOT: Median PFS was NR with CARVYKTI versus 12 months with standard therapies Median OS was NR with CARVYKTI versus NR with standard therapies. In patients with three pLOT: Median PFS was NR with CARVYKTI versus 8 months with standard therapies; Median OS was NR with CARVYKTI versus 34 months with standard therapies. These data further support a favorable benefit-risk profile for CARVYKTI as early as after first relapse for multiple myeloma patients who are lenalidomide-refractory and have a poor prognosis.