Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up.
Johnson & Johnson and Legend Biotech’s CAR T therapy Carvykti kept half of multiple myeloma patients alive and without disease progression after a median follow-up of at least five years.
This finding comes from Cohort A in the Phase 2 CARTITUDE-2 study, presented Friday at the International Myeloma Society annual congress in Glasgow. The group featured 20 patients who received a single dose of Carvykti after at least one prior line of treatment. At a median of 60.7 months of follow-up, 10 participants remained alive and showed no signs of disease progression. Overall survival at this timepoint was 69.2%.
Since the last data cut off, two deaths have occurred. One patient’s disease progressed, according to the Friday announcement. Another patient died due to the development of a new malignancy, which was breast cancer, a spokesperson for Legend told BioSpace in an email. None of the deaths observed in the cohort were deemed to be related to Carvykti, the spokesperson confirmed.
CARTITUDE-2 is a multicohort, open-label trial with more than 200 patients enrolled. Cohort A focused on patients who had received between one and three prior lines of therapy. Previous data from CARTITUDE-2 presented in November 2023 showed that at a median follow-up of around 29 months, all 17 evaluable patients in Cohort A showed no detectable signs of residual cancer cells in bone marrow samples after treatment—the trial’s primary endpoint.
At the time, Cohort A had accumulated five deaths. The deaths reported on Friday were new since the 29-month analysis. Of the seven total deaths in the study, one was considered related to cilta-cel, the spokesperson said.
CARTITUDE-2 also includes cohorts B to F, each with specific criteria based on prior treatment exposure.
Carvykti is a CAR T therapy that targets a protein called BCMA commonly expressed on malignant immune cells. In December 2017, J&J paid $350 million to license the asset. The FDA approved Carvykti in February 2022 for relapsed or refractory multiple myeloma and included a boxed warning for cytokine release syndrome, neurologic toxicities and secondary hematologic malignancies, among other side effects.
The CAR-T therapy “is more suitable for a younger and higher risk population due to the proven high efficacy balanced by known toxicities that might not be suitable for older and more fragile patients,” analysts at RBC Capital Markets wrote in a Sept. 9 note. Carvykti made nearly $1.9 billion worldwide last year.
Gilead is looking to challenge Carvykti in multiple myeloma with anito-cel, originally developed in collaboration with Arcellx, which the pharma acquired in February for $7.8 billion. Anito-cel is under FDA review, with a decision expected on Dec. 23.
