Study shows survival benefits in early use of J&J/Legend’s Carvykti in multiple myeloma

Johnson & Johnson announced updated results from a phase 3 study supporting durable treatment-free remissions as early as second line treatment with Carvykti, a BCMA-directed autologous T-cell immunotherapy jointly developed and commercialized by J&J’s Janssen Biotech and Legend Biotech.

In the analysis of CARTITUDE-4 data, 176 patients received Carvykti as early as second line and 59 of those patients had standard-risk cytogenetics. Follow-up data from the study show at least 80% of as-treated standard-risk patients with relapsed or refractory multiple myeloma (RRMM) remained progression and treatment-free at 2.5 years, following a single infusion as early as second line.

These data were featured in oral presentations at the 2025 American Society of Hematology (ASH) Annual Meeting.

“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,” said Luciano Costa, M.D., Ph.D., Professor of Medicine at the University of Alabama and principal investigator of the CARTITUDE-4 study.

Carvykti, first approved by the FDA in 2022 for the treatment of RRMM after four or more prior lines of therapy, holds the distinction of being the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. Carvykti’s approval was expanded in 2024, allowing use in patients who have received at least one prior line of therapy.