Johnson & Johnson (J&J) and Legend Biotech have shared positive results from a late-stage study of their BCMA-directed T-cell immunotherapy Carvykti (ciltacabtagene autoleucel) in previously-treated multiple myeloma.
The phase 3 CARTITUDE-4 has been comparing Carvykti against pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adults with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).
Results from an interim analysis demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with Carvykti versus the two standard regimens, and the safety data was reported to be consistent with the therapy’s approved label.
Jordan Schecter, vice president, disease area leader, multiple myeloma, J&J Innovative Medicine, said: “Carvykti… is now the first cell therapy to significantly improve OS versus standard of care for patients with myeloma as early as [the] second line.”
More than 35,000 new cases of multiple myeloma, an incurable blood cancer that affects a type of white blood cell called plasma cells, are expected to be diagnosed in the US in 2024.
Carvykti is prepared using a patient’s own T-cells, which are extracted from the blood, genetically modified, and then given back to the patient via a single infusion into a vein.
The therapy already holds authorisation to treat certain adults with previously-treated multiple myeloma and was most recently approved by the European Commission to treat those with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an IMiD and a PI, have demonstrated disease progression on the last therapy and are refractory to lenalidomide.
Commenting on the latest readout for the therapy, Ying Huang, Legend’s chief executive officer, said: “We are gratified to have observed an OS benefit with a one-time infusion of Carvykti in the latest analysis of the CARTITUDE-4 study.
“This latest data point builds on the growing body of evidence from CARTITUDE-4 that shows the significant benefit Carvykti offers multiple myeloma patients battling an incurable disease.”
A detailed analysis of the trial will now be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide, the companies said.