J&J's Carvykti boosts survival in myeloma study

Johnson & Johnson and Legend Biotech's BCMA-directed CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), has shown significant improvement in overall survival (OS) for patients with relapsed or lenalidomide-refractory multiple myeloma (MM) after one prior line of therapy. Jordan Schecter, who leads the disease area for multiple myeloma at Johnson & Johnson Innovative Medicine, announced on Tuesday that this "one-time infusion" is the first cell therapy to substantially improve overall survival compared to the standard of care for multiple myeloma patients as early as the second line of treatment.

The promising results originate from the Phase III CARTITUDE-4 study. Previously, Johnson & Johnson reported that the study had achieved its primary endpoint of progression-free survival (PFS). Data presented at last year’s American Society of Clinical Oncology (ASCO) annual meeting showed that Carvykti reduced the risk of disease progression or death by an impressive 74% compared to standard treatments. These PFS findings have supported recent approvals of the therapy in both the U.S. and Europe for second-line settings.

On Tuesday, Johnson & Johnson highlighted that the new OS results, derived from a prespecified second interim analysis of the CARTITUDE-4 trial, are clinically significant and meaningful. The company plans to present these findings at an upcoming medical conference and submit them to regulatory authorities for review.

The OS data from CARTITUDE-4 may also strengthen Carvykti’s leading position among CAR-T therapies and bispecific antibodies for second-line multiple myeloma treatment. A recent poll by FirstWord indicated that about 40% of respondents are likely or very likely to prescribe Carvykti as a second-line treatment for both transplant-eligible and transplant-ineligible multiple myeloma patients. This positions Carvykti ahead of Bristol Myers Squibb’s CAR-T therapy, Abecma (idecabtagene vicleucel), as well as various bispecific antibody treatments.