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23rd April 2024
A type II variation of ciltacabtagene autoleucel (cilta-cel; brand name Carvykti) has been approved by the European Commission (EC) for use in the treatment of eligible patients with multiple myeloma, its manufacturer Janssen has announced.
Cilta-cel has been recommended for adult patients with relapsed and refractory (R/R) multiple myeloma, who have received at least one prior therapy including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
Cilta-cel is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA) and is the first BCMA CAR-T therapy approved in Europe for the treatment of eligible patients as early as first relapse.
The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024.
Professor Jesús San Miguel, director of clinical & translational medicine at the University of Navarra in Pamplona, Spain, said: ‘Patients with lenalidomide-refractory multiple myeloma tend to experience early resistance to standard treatments and their disease worsens exponentially with each additional line of therapy.
‘A single infusion of cilta-cel has been shown to significantly lower the risk of progression or death compared to current treatment options, as early as after first relapse.’
The EC approval was based on the results of a phase 3 CARTITUDE-4 clinical trial evaluating the efficacy and safety of cilta-cel in patients with relapsed and lenalidomide-refractory multiple myeloma.
Data from the study were previously published in the New England Journal of Medicine.
The primary endpoint was progression-free survival (PFS), defined as the time from randomisation to the first documentation of disease progression or death.
In total, 419 patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy underwent randomisation.
Patients were randomised to receive either a sequence of apheresis, bridging therapy, lymphodepletion and cilta-cel (n=208) or standard of care, which included daratumumab, pomalidomide and dexamethasone (DPd) or pomalidomide, bortezomib and dexamethasone (PVd) (n=211).
At a median follow-up of 15.9 months, a single infusion of cilta-cel gave rise to a significantly lower risk of disease progression or death compared to standard care (hazard ratio, HR = 0.26, 95% CI 0.18 – 0.38, p < 0.001).
The median duration of PFS was not reached in the cilta-cel arm and was 11.8 months in the standard care arm (95% CI, 10-14).
After 12 months, PFS was 75.9% (95% CI 69.4 – 81.1) in the cilta-cel group and 48.6% (95% CI 41.5 – 55.3) in the standard care group. In addition, a higher proportion of patients in the cilta-cel group had an overall response (84.6% vs. 67.3%), a complete response or better (73.1% vs 21.8%) and an absence of minimal residual disease (60.6% vs. 15.6%).
In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% vs 94.2%, cilta-cel vs standard care).
13th March 2024
A type II variation of ciltacabtagene autoleucel (cilta-cel; brand name Carvykti) has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for use in the treatment of eligible patients with multiple myeloma, its manufacturer Janssen has announced.
Cilta-cel has been recommended for adult patients with relapsed and refractory (R/R) multiple myeloma, who have received at least one prior therapy including an immunomodulatory agent and a proteasome inhibitor, demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
Cilta-cel is a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy and is the first CAR T-cell therapy to receive a positive CHMP opinion for this patient population as early as second line.
It is currently approved under conditional marketing authorisation in the EU for the treatment of adults with R/R multiple myeloma, after three prior lines of therapy.
Edmond Chan, EMEA lead for haematology at Janssen-Cilag, said: ‘Early resistance to standard treatments is becoming more common in patients with lenalidomide-refractory multiple myeloma, highlighting a need for new options earlier in the course of treatment.’
He added that the CHMP recommendation ‘recognises the potential of cilta-cel to significantly improve outcomes for eligible patients with relapsed and refractory multiple myeloma, as early as after first relapse.’
The CHMP recommendation was based on the results of a phase 3 CARTITUDE-4 clinical trial comparing the CAR T-cell therapy directed against b-cell maturation antigen versus the standard care treatment, which was the physician’s choice of pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone.
The primary endpoint was progression-free survival, defined as the time from randomisation to the first documentation of disease progression or death.
In total, 419 patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy underwent randomisation, with 208 (mean age 61.5 years, 55.8% male) receiving cilta-cel.
Cilta-cel treatment gave rise to a significantly lower risk of disease progression or death compared to standard care (hazard ratio, HR = 0.26, 95% CI 0.18 – 0.38, p < 0.001).
After 12 months, PFS was 75.9% (95% CI 69.4 – 81.1) in the cilta-cel group and 48.6% (95% CI 41.5 – 55.3) in the standard care group. In addition, a higher proportion of patients in the cilta-cel group had an overall response (84.6% vs. 67.3%), a complete response or better (73.1% vs. 21.8%) and an absence of minimal residual disease (60.6% vs. 15.6%).
In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% vs 94.2%, cilta-cel vs standard care).
9th June 2023
A cilta-cel infusion lowers the risk of disease progression or death compared to standard care in lenalidomide-refractory patients with multiple myeloma, according to the findings of a recent randomised trial.
Multiple myeloma represents a malignant disease of plasma cells with a worldwide incidence of 6-7 cases per 100 000 persons per year. Lenalidomide is an immunomodulatory drug for maintenance treatment in newly diagnosed multiple myeloma which improves progression-free survival (PFS). But when patients fail to respond to lenalidomide, what is the most appropriate therapy?
This was the question addressed in a recent study published in the New England Journal of Medicine. Researchers undertook a randomised trial of cilta-cel – a B-cell maturation antigen-directed CAR-T cell therapy – in patients with lenalidomide-refractory disease.
All participants had received one to three prior therapies and were equally randomised to either cilta-cel or the physician’s choice of effective standard care. The physician’s standard care was pomalidomide, bortezomib and dexamethasone, or daratumumab, pomalidomide and dexamethasone. Researchers set the primary outcome as PFS, defined as the time from randomisation to the first documentation of disease progression or death.
In total, 419 patients underwent randomisation, with 208 (mean age 61.5 years, 55.8% male) receiving cilta-cel.
Cilta-cel treatment gave rise to a a significantly lower risk of disease progression or death compared to standard care (hazard ratio, HR = 0.26, 95% CI 0.18 – 0.38, p < 0.001).
After 12 months, PFS was 75.9% (95% CI 69.4 – 81.1) in the cilta-cel group and 48.6% (95% CI 41.5 – 55.3) in the standard care group. In addition, a higher proportion of patients in the cilta-cel group had an overall response (84.6% vs. 67.3%), a complete response or better (73.1% vs. 21.8%) and an absence of minimal residual disease (60.6% vs. 15.6%).
In terms of safety, Grade 3 or 4 adverse events occurred in a similar proportion of participants in the two groups (96.6% vs 94.2%, cilta-cel vs standard care).
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