Johnson & Johnson declares data from Phase III multiple myeloma treatment trial

Johnson & Johnson (J&J) has announced positive results from the second interim analysis of the Phase III CARTITUDE-4 trial evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for relapsed or lenalidomide-refractory multiple myeloma after one prior therapy line. The randomized study compares CARVYKTI against standard treatments like pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

Participants include adults who have undergone one to three prior therapy lines. Progression-free survival (PFS) is the primary endpoint, with overall survival (OS), minimal residual disease negative rate, and overall response rate as secondary endpoints.

Interim analysis data demonstrated that patients treated with CARVYKTI showed significant and clinically meaningful improvements in OS compared to those receiving standard therapies. Safety data aligned with the therapy’s approved label.

CARVYKTI received FDA approval in February 2022 for treating adults with relapsed or refractory multiple myeloma after four or more prior therapy lines.