Legend Biotech Sees Bright Future for Blockbuster CAR-T Therapy
Legend Biotech, a leader in cell therapy, has achieved significant milestones in its fourth quarter of 2024 performance. The company's CEO, Ying Huang, highlighted the impressive progress made in bringing its CAR-T therapy, CARVYKTI, to patients with multiple myeloma.
In a recent conference call, Legend Biotech executives discussed the therapy's unique profile, which has demonstrated a survival benefit compared to standard of care. The company shared new results from the Phase III CARTITUDE-4 study, showing that 89% of evaluable patients achieved minimal residual disease negativity with a single infusion of CARVYKTI after a 3-year follow-up, compared to 38% for those treated with standard of care.
The FDA Committee's recent recommendation on the use of marginal activity as a potential surrogate endpoint in multiple myeloma trials creates additional opportunities for approval. Furthermore, CARVYKTI outcomes data has been published by the International Myeloma Working Group, which has made recommendations on sequencing therapy for the treatment of multiple myeloma, with CAR-T therapy being prioritized first for patients who are reasonable candidates.
The company's sales trajectory since launch is a testament to CARVYKTI's unique profile and strong manufacturing and commercial execution. Legend Biotech and its partner, J&J, have pioneered a large-scale effort in the field of multiple myeloma for CAR-T therapy.
Notably, the FDA has approved the company's CMO, Novartis facility, for commercial production of CARVYKTI in New Jersey. Commercial production is expected to begin at Legend Biotech's Tech Lane facility in GantBelgium later this year, meeting the increasing demand and serving patients in Europe.
The early launch performance of CARVYKTI has been impressive, with the company continuing its commitment to bringing the therapy to all eligible patients in the U.S. and Europe who might benefit from its differentiated efficacy. The company's goal is to achieve blockbuster status and operational breakeven for CARVYKTI by 2025 and company-wide profitability in 2026.
