Johnson & Johnson Reports Durable Remissions With CARVYKTI In CARTITUDE-4 Study

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(RTTNews) - Johnson & Johnson (JNJ) announced updated results from the Phase 3 CARTITUDE-4 study, reinforcing the potential of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) to deliver durable, treatment-free remissions in patients with relapsed or refractory multiple myeloma (RRMM).

At 2.5 years (30 months) of follow-up, 80 percent of as-treated patients with standard-risk cytogenetics who received CARVYKTI as early as first relapse remained progression-free and required no further treatment. These findings add to the growing body of evidence from both clinical trials and real-world practice, where more than 9,000 patients worldwide have been treated with CARVYKTI.

Translational analyses presented at the 2025 American Society of Hematology (ASH) Annual Meeting demonstrated that patients treated earlier in their disease course exhibited improved immune fitness, which correlated with longer progression-free survival (PFS).

In CARTITUDE-4, 176 patients received CARVYKTI as early as second line, including 59 with standard-risk cytogenetics. At a median follow-up of 33.6 months, the 30-month PFS rate plateaued at 80.5% (95% CI, 67.2-88.8) after a single infusion. Notably, all 26 patients who achieved minimal residual disease (MRD)-negative complete response at 12 months remained progression-free at 30 months.

Further biomarker analyses across CARTITUDE-1 and CARTITUDE-4 revealed that patients treated after one or two prior lines of therapy had higher baseline CD4? naïve T cells, indicating stronger immune fitness compared to those treated after three or more prior lines. Bone marrow profiling also showed a more immune-activated environment in patients treated earlier, supporting the link between immune biomarkers and improved survival outcomes.

As CARVYKTI adoption expands across academic centers and community practices, Johnson & Johnson continues to collect and analyze both clinical and real-world data. This comprehensive evidence base strengthens confidence in CARVYKTI's role in earlier treatment settings and provides a foundation for broadening its use across diverse patient populations.

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