FX.co ★ J&J : Phase 3 Trial Results Show CARVYKTI Extends Overall Survival In Relapsed Multiple Myeloma

Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has reported promising three-year follow-up results from the Phase 3 CARTITUDE-4 study. These results indicate that a single infusion of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) significantly improves overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma who have undergone at least one prior line of therapy, including a proteasome inhibitor (PI). Specifically, cilta-cel was found to reduce the risk of death by 45% compared to standard therapies such as pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

The company highlighted that CARVYKTI is now the first and only cell therapy to demonstrate an improvement in overall survival versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as the second line of treatment.

At a median follow-up of nearly three years (34 months), the median overall survival for patients treated with either cilta-cel or standard therapies had not been reached [(95% Confidence Interval [CI], not estimable (NE)-NE) and (95% CI, 37.75 months-NE) (Hazard Ratio [HR], 0.55; 95% CI, 0.39-0.79; p=0.0009)].

Moreover, at the 30-month follow-up mark, the overall survival rates were 76% for those on the cilta-cel arm versus 64% for those on the standard therapies arm. These findings underscore that cilta-cel significantly extends overall survival compared to standard treatments.

In December 2017, Janssen Biotech, Inc., another Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc., to develop and commercialize cilta-cel.