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

(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company, announced three-year follow-up data from the Phase 3 CARTITUDE-4 study that showed a single infusion of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) significantly extended overall survival (OS) in patients with relapsed or lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI). Cilta-cel reduced the risk of death by 45 percent versus standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).

The company said that CARVYKTI is now the first and only cell therapy to improve overall survival versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line.

According to the company, at median follow-up of almost three years (34 months), median overall survival for patients treated with both cilta-cel or standard therapies was not reached [(95 percent Confidence Interval [CI], not estimable (NE)-NE) and (95 percent CI, 37.75 months-NE) (Hazard Ratio [HR], 0.55; 95 percent CI, 0.39-0.79; p=0.0009)].

At 30-month follow-up, overall survival rates were 76 percent for patients on the cilta-cel arm and 64 percent for patients on the standard therapies arm. These data show cilta-cel significantly extended overall survival for patients compared to standard therapies.

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

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