Johnson & Johnson (J&J) has announced positive long-term results from the Phase 3 CARTITUDE-4 study of Carvykti (cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma.
The study compared Carvykti, an autologous T-cell immunotherapy, to standard therapies of pomalidomide, bortezomib, and dexamethasone (PVd), or daratumumab, pomalidomide, and dexamethasone (DPd).
It randomised 419 patients who had received one to three prior lines of therapy.
After a median follow-up of 34 months, the median overall survival (OS) was not reached for either group.
The study showed that a single infusion of Carvykti significantly improved OS for patients with relapsed or lenalidomide-refractory multiple myeloma.
The OS rates at 30 months were 76% for cilta-cel and 64% for standard therapies. The data demonstrated that Carvykti significantly extended OS compared to standard treatments.
Patients who received cilta-cel had a 45% lower risk of death compared to standard therapies.
The median progression-free survival (PFS) was not reached for Carvykti, while it was 11.8 months for standard therapies.
Patients treated with cilta-cel achieved a complete response or better in 77% of cases, with an overall response rate of 85%.
The safety profile of T-cell immunotherapy compared to standard therapies was consistent with prior analyses.
Johnson & Johnson innovative medicine multiple myeloma disease area leader 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.”
Earlier this year, the US Food and Drug Administration (FDA) and European Commission (EC) approved cilta-cel for the same indication.
Carvykti has now been launched in five countries, and over 3,500 patients have been treated globally.
In December 2017, Janssen Biotech, a Johnson & Johnson company, entered into a worldwide licensing and collaboration agreement with Legend Biotech USA to develop and commercialise the drug.
Carvykti received FDA approval in February 2022 for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
