Johnson & Johnson has announced updated results from the phase 3 CARTITUDE-4 study, showing that CARVYKTI (ciltacabtagene autoleucel; cilta-cel) can deliver durable treatment-free remissions as early as second line therapy for patients with relapsed or refractory multiple myeloma.
In the trial, 80 percent of as-treated patients with standard-risk cytogenetics who received cilta-cel after first relapse remained progression- and treatment-free at 2.5 years. These findings add to the growing clinical and real-world evidence from more than 9,000 patients treated globally.
Luciano J Costa, Professor of Medicine at the University of Alabama and principal investigator of CARTITUDE-4, said: “These data suggest that a single infusion of cilta-cel for standard-risk patients may provide additional benefit to patients as early as second line of therapy. Treating patients with multiple myeloma after first relapse offers the opportunity to achieve deep and durable responses, shifting the treatment paradigm closer to the possibility of long-term remission.”
Jordan Schecter, Vice President, Research & Development, Multiple Myeloma, Johnson & Johnson Innovative Medicine, explained: “Our goal is to treat patients as early as possible, when they have the best chance for lasting remission. With more than 9,000 patients treated globally, cilta-cel has demonstrated robust efficacy as soon as first relapse and is the only CAR-T to significantly extend overall survival versus standard therapies.”
At a median follow-up of 33.6 months, the 30-month progression-free survival rate plateaued at 80.5 percent among standard-risk patients. All 26 patients who achieved minimal residual disease-negative complete response at 12 months remained progression-free at 30 months.
Ester in ‘t Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine, said: “Our mission in multiple myeloma is to deliver transformational innovations that fundamentally shift the trajectory of disease and extend and improve patients’ lives. The data presented at ASH add to the growing body of evidence confirming the potential of cilta-cel to do just that.”
The company continues to collect and analyse long-term clinical and real-world data to support broader use of cilta-cel in earlier treatment settings.
