Legend Biotech to Demonstrate Progress in Advancing Potential Treatment Options for Patients with Multiple Myeloma

Legend Biotech Corporation, a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, has announced that new and updated data from the CARTITUDE Clinical Development Program evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association’s (EHA) 2023 Hybrid Congress. Five-year follow-up data from Legend-2 (NCT03090659), an investigator-initiated trial that has been assessing a similar CAR construct since 2015, will also be presented at the meetings.

From the CARTITUDE Clinical Development Program, the first analysis of the Phase 3 CARTITUDE-4 study was accepted as a late breaking abstract at ASCO and will be presented as an oral presentation at both ASCO and in a plenary session at EHA. CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study investigating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received cilta-cel vs standard-of-care regimens, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), following one to three prior lines of therapy.

“We are pleased that the latest data from the CARTITUDE-4 study will be officially presented at the meetings. We are continuing to investigate cilta-cel in earlier lines of treatment and the readout from this study is crucial to how we move forward,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We also eagerly anticipate the presentation of the five-year follow-up data from Legend-2 at ASCO. This was the study that showed — in front of the international community back in 2017 —promising results in heavily pretreated patients with multiple myeloma. Since then, we have taken significant steps toward advancing the treatment landscape for myeloma patients in the CARTITUDE Development Program and are exploring the potential of other agents in our pipeline for this and other indications.”

Additional data at this year’s meetings will include longer-term results from the final protocol-specified analysis of the CARTITUDE-1 study (NCT03548207), which will be shared as a poster presentation at ASCO and an oral presentation at EHA. CARTITUDE-1 is a Phase 1b/2 study evaluating cilta-cel for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma. The study’s 18-month follow-up data supported the U.S. Food and Drug Administration (FDA) approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in February 2022.

Data from the 5-year follow-up analysis of LEGEND-2 will be presented as a poster at ASCO and EHA. This first-in-human, Phase 1 study evaluates LCAR-B38M CAR-T cells in patients with relapsed and refractory multiple myeloma. It is the longest follow-up for any BCMA-targeted CAR-T cell therapy study to be presented at the meetings.