Genscript Bio (01548) announced that Legend Biotech (NASDAQ: LEGN) released the positive overall survival (OS) results of the CARTITUDE4 study in Somerset County, New Jersey, USA. This is a global randomized open-label Phase III study evaluating the efficacy and safety of CARVYKTI (cilta-cel, ide-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and refractory multiple myeloma who are resistant to lenalidomide. These patients had been previously treated with one to three lines of therapy, including proteasome inhibitors (PI) and immunomodulators (IMiDs). In the pre-specified trial's second interim analysis, CARVYKTI demonstrated a statistically significant and clinically meaningful improvement in OS. Safety was consistent with the known safety profile of CARVYKTI, and no new safety signals were identified.
Futubull Financial News App reports that Genscript Bio (01548) announced that Legend Biotech (NASDAQ: LEGN) released the positive overall survival (OS) results of the CARTITUDE4 study in Somerset County, New Jersey, USA. This is a global randomized open-label Phase III study evaluating the efficacy and safety of CARVYKTI (cilta-cel, ide-cel) versus pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in adult patients with relapsed and refractory multiple myeloma who are resistant to lenalidomide. These patients had been previously treated with one to three lines of therapy, including proteasome inhibitors (PI) and immunomodulators (IMiDs). In the pre-specified trial's second interim analysis, CARVYKTI demonstrated a statistically significant and clinically meaningful improvement in OS. Safety was consistent with the known safety profile of CARVYKTI, and no new safety signals were identified.
Dr. Ying Huang, CEO of Legend Biotech, said, "We are delighted to observe overall survival benefit with a single infusion of CARVYKTI in the latest analysis of the CARTITUDE-4 study. Based on this latest data from the increasing evidence from CARTITUDE-4 study, CARVYKTI offers significant benefits to patients fighting this incurable disease."
These latest results will be presented at an upcoming medical conference and shared with regulatory authorities to update product labels globally.
Data from CARTITUDE-4 support the US FDA's approval of CARVYKTI on April 5, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and who are refractory to lenalidomide. CARVYKTI is the first and only FDA-approved CAR-T cell therapy targeting BCMA for the treatment of multiple myeloma patients who have received at least one prior line of therapy.
CARVYKTI (ciltacabtagene autoleucel) is a transgenic autologous T cell immunotherapy targeting B-cell maturation antigen (BCMA), approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (including proteasome inhibitors and immunomodulators) and are refractory to lenalidomide.