New long-term data from the Phase III CARTITUDE-4 (NCT04181827) trial indicates that early administration of Johnson & Johnson (J&J)’s Carvykti (ciltacabtagene autoleucel) produced durable, treatment-free remissions in patients with relapsed or refractory multiple myeloma (RRMM) who received one to three prior lines of therapy.¹

Data collected from the study showed upwards of 80% of as-treated standard-risk patients administered Carvykti as early as first relapse did not experience disease progression and no further treatment was required at 30 months.

J&J’s announcement builds on the previously established clinical and real-world experiences of over 9,000 patients treated with Carvykti.¹ 

“These data suggest that a single infusion of Carvykti for standard-risk patients may provide additional benefit to patients as early as second line of therapy,” CARTITUDE-4 principal investigator Luciano J. Costa, MD, PhD, professor of Medicine at the University of Alabama, said in a press release. “Treating patients with multiple myeloma after first relapse offers the opportunity to achieve deeper and more durable responses, shifting the treatment paradigm closer to the possibility of long-term remission and, ultimately, cure.”

Carvykti, a chimeric antigen receptor (CAR) T-cell therapy, was approved by the FDA in February 2022 for adults with RRMM following four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In April 2024, Carvykti became the first FDA-approved cell therapy for adults with RRMM who received at least one prior line of therapy including a PI, an immunomodulatory agent, and who are refractory to lenalidomide.²

J&J’s Cartitude-4 Phase III clinical trial

The global, randomized, controlled CARTITUDE-4 trial is comparing Carvykti with standard treatments consisting of pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone. The trial is being conducted in three phases—screening, which is occurring up to 28 days prior to randomization, treatment, and follow-up.

According to J&J, follow-up now extends to 30 months, in which a significant proportion of patients remain both progression-free and off additional therapy.

J&J noted that the trial has continued to show a reduced risk of disease progression and death among patients treated with Carvykti compared to those treated with standard treatment regimens.

Median progression-free survival has not yet been reached, with trends favoring sustained benefit relative to investigator-selected standard-of-care therapies. The company also emphasized that many patients underwent long stretches without requiring subsequent lines of therapy, a departure from the continuous-treatment paradigm common in patients with multiple myeloma.

The safety profile reported at 30 months was consistent with previous observations for BCMA-targeted CAR T-cell therapies, with rates and severity of cytokine release syndrome and immune-effector cell–associated neurotoxicity aligning with earlier datasets from the Cartitude program.¹ Most events occurred shortly after infusion and were resolved with standard management approaches.

Investigators underscored that patients with RRMM who are refractory to lenalidomide often face diminishing responses to available options, emphasizing the need for earlier deployment of cell therapies that may provide deeper or more durable remissions.

“Our goal is to treat patients as early as possible, when they have the best chance for lasting remission,” said Jordan Schecter, MD, vice president, research & development, multiple myeloma, Johnson & Johnson Innovative Medicine. “With more than 9,000 patients treated globally, Carvykti has demonstrated robust efficacy as soon as first relapse and is the first and only CAR T to significantly extend overall survival versus standard therapies.”

Sources

1. Earlier use of Carvykti demonstrated lasting treatment-free remissions at 2.5 years in patients with relapsed or refractory multiple myeloma Johnson and Johnson December 6, 2025 https://www.jnj.com/media-center/press-releases/earlier-use-of-carvykti-demonstrated-lasting-treatment-free-remissions-at-2-5-years-in-patients-with-relapsed-or-refractory-multiple-myeloma
2. U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. News release. Johnson & Johnson. February 28, 2022. Accessed December 8, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-a-bcma-directed-car-t-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma