Johnson & Johnson declares positive results from phase 3 CARTITUDE-4 study of Carvykti to treat relapsed or lenalidomide-refractory multiple myeloma

Johnson & Johnson reported positive results from the phase 3 CARTITUDE-4 study's second interim analysis, comparing Carvykti (ciltacabtagene autoleucel; cilta-cel) with standard therapies (pomalidomide, bortezomib, and dexamethasone [PVd] or daratumumab, pomalidomide, and dexamethasone [DPd]) in relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy. The analysis showed a significant improvement in overall survival (OS) with Carvykti versus standard treatments. Safety data were consistent with the approved profile.

Further details will be presented at an upcoming medical meeting and submitted to regulatory agencies worldwide.

CARTITUDE-4 (NCT04181827) is the first randomized phase 3 trial assessing Carvykti's efficacy and safety in adults who have received one to three prior lines of therapy. Primary endpoint is progression-free survival (PFS), with OS, minimal residual disease negativity, and overall response rate as secondary measures.

Carvykti, a BCMA-directed autologous T-cell therapy, received US FDA approval in February 2022 for relapsed or refractory multiple myeloma. It targets BCMA on malignant plasma cells, offering a promising treatment option for this incurable disease.