J&J : CARVYKTI Shows Higher MRD Negativity Rates Vs. Standard Therapies In Phase 3 Study

Johnson & Johnson

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(RTTNews) - Johnson & Johnson (JNJ) announced new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease or MRD negativity rates (10-5) in patients with relapsed or refractory multiple myeloma or RRMM who were lenalidomide-refractory and had received one to three prior lines of therapy, including a proteasome inhibitor or PI, compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).

Minimal residual disease is a prognostic marker of prolonged survival outcomes for patients with multiple myeloma.

At a median follow-up of almost three years (34 months), MRD-negativity rates for evaluable patients were more than double in those treated with CARVYKTI versus standard therapies (89 percent, 38 percent; P<0.0001).

At 2.5 years, sustained (12 months or more), MRD-negative complete response or better in evaluable patients treated with CARVYKTI was five-fold higher than that of standard therapies (52 percent, 10 percent; P<0.0001).

A post-hoc comparison between CARTITUDE-4 and CARTITUDE-1 was also presented, comparing earlier treatment (1-3 versus 3+ prior lines of therapy) demonstrating higher rates of MRD negativity, progression-free survival (PFS) and OS rates when CARVYKTI is used earlier in treatment.

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