Legend Biotech to Present Comprehensive CARVYKTI Data and First-in-Human Allogeneic CAR-T Results at ASH 2025
核心洞察
Legend Biotech will present nine abstracts on CARVYKTI (ciltacabtagene autoleucel) at the 67th ASH Annual Meeting, including two oral presentations demonstrating long-term progression-free survival benefits and improved immune fitness with earlier treatment use.
The company will deliver first-in-human Phase 1 data for Lucar-G39D, an investigational anti-CD20 (搜索)/CD19 (搜索) dual-CAR allogeneic gamma delta T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma (搜索).
CARVYKTI is now commercially available in 14 countries and has treated more than 9,000 patients as the first and only BCMA (搜索)-targeted CAR-T therapy approved for multiple myeloma (搜索) patients with at least one prior line of therapy.
Legend Biotech Corporation announced it will present 10 abstracts at the 67th Annual American Society of Hematology (ASH) Annual Meeting from December 6-9, 2025, in Orlando, Florida. The presentations include nine abstracts on CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for multiple myeloma (搜索) and first-in-human data for its next-generation allogeneic CAR-T cell therapy.
CARVYKTI Presentations Demonstrate Clinical Impact
The company will deliver two oral presentations highlighting key clinical findings from the CARTITUDE studies. The first presentation will focus on long-term progression-free survival benefits with ciltacabtagene autoleucel in standard-risk relapsed/refractory multiple myeloma (搜索) patients. The second oral presentation will demonstrate that earlier use of cilta-cel is associated with better immune fitness and stronger immune effects, based on correlative analysis of peripheral blood and bone marrow tumor microenvironment from the CARTITUDE-4 study.
"With nine abstracts highlighting CARVYKTI, these presentations further demonstrate the durability of responses, evolving safety profile, and real-world outcomes that support the potential of CAR-T therapy earlier in the multiple myeloma (搜索) treatment journey," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech.
Seven poster presentations will provide additional clinical insights, including effectiveness of bridging therapy, comparative efficacy analyses, quality-adjusted survival analysis of neurologic events, and real-world manufacturing outcomes. The presentations will cover data from both the CARTITUDE-1 and CARTITUDE-4 studies, which evaluated cilta-cel in patients with relapsed and refractory multiple myeloma (搜索).
First-in-Human Allogeneic CAR-T Data
Legend Biotech will present first-in-human Phase 1 data for Lucar-G39D, a novel anti-CD20 (搜索)/CD19 (搜索) dual-CAR allogeneic gamma delta T cell therapy being evaluated in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (搜索). This oral presentation represents the company's expansion into next-generation allogeneic cell therapies for B-cell malignancies.
"Our first-in-human data on Lucar-G39D highlights our ongoing efforts to expand our pipeline into next-generation allogeneic cell therapies for patients with B-cell malignancies," Huang noted.
CARVYKTI Commercial Success and Safety Profile
CARVYKTI is the first and only BCMA (搜索)-targeted CAR-T cell therapy approved for treatment of patients with multiple myeloma (搜索) who have had at least one prior line of therapy. The therapy is now commercially available in 14 countries and has been used to treat more than 9,000 patients to date.
The therapy carries significant safety warnings, including cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged and recurrent cytopenia, and secondary hematological malignancies. Among patients receiving CARVYKTI for relapsed/refractory multiple myeloma (搜索) in the CARTITUDE-1 and CARTITUDE-4 studies (N=285), CRS occurred in 84% of patients, including Grade 3 or higher CRS in 4% of patients.
Neurologic toxicities occurred in 24% of patients, including Grade 3 cases in 7% of patients. The median time to onset was 10 days, with 91% of cases developing by 30 days. Neurologic toxicities resolved in 72% of patients with a median duration to resolution of 23 days.
Clinical Trial Background
The CARTITUDE-4 study is an ongoing, international, randomized, open-label Phase 3 study evaluating cilta-cel versus pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide, and dexamethasone in adult patients with relapsed and lenalidomide-refractory multiple myeloma (搜索) who received one to three prior lines of therapy.
The CARTITUDE-1 study is a Phase 1b/2, open-label, multicenter study evaluating safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma (搜索) who have received at least three prior lines of therapy or are double refractory to a proteasome inhibitor and immunomodulatory drug.