Johnson & Johnson (J&J) and Legend Biotech have shared positive long-term results for their BCMA-directed T-cell immunotherapy, Carvykti (ciltacabtagene autoleucel), in previously-treated multiple myeloma.
The phase 3 CARTITUDE-4 study has been evaluating 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).
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.
Results presented at this year’s International Myeloma Society Annual Meeting showed that Carvykti reduced the risk of death by 45% compared to the standard therapies after a median follow-up of almost three years.
Median overall survival (OS) was not reached in either arm but, at month 30, OS rates were 76% for patients receiving Carvykti and 64% for those being treated with PVd or DPd.
Carvykti is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as second line, according to the companies.
The therapy already holds approvals 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.
Study investigator Binod Dhakal, Medical College of Wisconsin, said: “The three-year follow-up data from the phase 3 CARTITUDE-4 study shows a statistically significant and clinically meaningful improvement in OS and quality-of-life measures with Carvykti versus standard therapies – meaningful results that have the potential to transform the multiple myeloma treatment landscape.
“This adds to the growing body of data reinforcing the promise of a single infusion of Carvykti, which, in addition to demonstrating a significant os benefit, also offers patients the opportunity of a period free from multiple myeloma treatment as early as second line.”