Johnson & Johnson has reported data from the Phase III CARTITUDE-4 clinical trial where CARVYKTI (ciltacabtagene autoleucel), its cell therapy, demonstrated to significantly improve overall survival in patients with multiple myeloma.
The trial included patients who had received at least one prior line of therapy, including a proteasome inhibitor (PI).
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It compared CARVYKTI to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in a randomised setting.
Patients were eligible if they had one to three lines of therapy previously, including a PI and an immunomodulatory agent (IMiD), and were lenalidomide-refractory.
According to the data from the 30-month follow-up, overall survival (OS) rates were 76% for subjects treated with CARVYKTI versus 64% for those receiving standard therapies.
CARVYKTI also reduced the mortality risk by 45% versus standard therapies.
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By GlobalDataThe median progression-free survival (PFS) was not reached (NR) in the CARVYKTI group, indicating sustained deep and durable responses, while it was 11.79 months for those on standard therapies.
Patients on CARVYKTI achieved a 77% complete response or better, with an 85% overall response rate.
The therapy’s safety profile in the trial was in line with previous analyses.
In the safety analysis, 97% of patients in both treatment groups experienced grade 3/4 treatment-emergent adverse events (TEAEs), with cytopenia being the most common one.
Earlier this year, CARVYKTI received approval from the US Food and Drug Administration and the European Commission for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a PI, IMiD, and are refractory to lenalidomide.
Johnson & Johnson Innovative Medicine Multiple Myeloma Disease Area Leader vice-president Jordan Schecter said: “CARVYKTI is the first and only cell therapy approved for the treatment of patients with myeloma as early as second line, and now also the first and only cell therapy to improve overall survival and demonstrate improved patient quality-of-life outcomes versus standard therapies for patients with lenalidomide-refractory multiple myeloma.”
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