NEW YORK – Janssen and Legend Biotech on Friday said that they will unblind a Phase III trial of Carvykti (ciltacabtagene autoleucel) in relapsed or refractory multiple myeloma patients and discuss the positive findings with health authorities.
In the CARTITUDE-4 trial, the companies are comparing the activity of their autologous B-cell maturation antigen (BCMA)-directed CAR T-cell therapy against standard-of-care chemotherapy in relapsed or refractory multiple myeloma patients after prior treatment with Bristol Myers Squibb's Revlimid (lenalidomide). According to Janssen and Legend, which are codeveloping and co-commercializing Carvykti, the trial has met its primary endpoint and shown that the drug improves progression-free survival versus chemo. At the recommendation of an independent data monitoring committee, the randomized study will be unblinded.
Janssen and Legend will also present detailed findings at an upcoming medical meeting and discuss regulatory submissions with health authorities. The trial will continue even after unblinding so that Janssen and Legend can monitor secondary endpoints, including overall survival, safety, overall response rates, and minimal residual disease negativity rates.
Carvykti is already approved in the US as a fifth- or later-line multiple myeloma treatment and in Europe and Japan as a fourth- or later-line option. The CARTITUDE-4 trial now opens the door for Legend and Janssen to move Carvykti to earlier lines of treatment since it involves patients who have received one-to-three prior treatments.
In the BCMA-directed CAR T-cell therapy space, Carvykti competes with Bristol Myers Squibb's Abecma (idecabtagene vicleucel), which has recently shown benefit in multiple myeloma patients as an earlier-line treatment.