CARVYKTI received approval from the US FDA to treat adults with relapsed or refractory multiple myeloma. Credit: /

The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that the Phase III CARTITUDE-4 clinical trial of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) to treat relapsed and lenalidomide-refractory multiple myeloma met its primary endpoint.

In the trial, CARVYKTI was evaluated against pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd).

The Independent Data Monitoring Committee recommended the unblinding of the Phase III trial, as it met its endpoint of significant improvement in progression-free survival (PFS) at the initial pre-specified interim analysis.

Janssen Research & Development Clinical Development Cellular Therapy Program vice-president Jordan Schecter said: “The CARTITUDE-4 study represents the first Phase III programme in our comprehensive clinical development strategy for CARVYKTI, and further demonstrates our commitment to advance the treatment of patients with relapsed/refractory multiple myeloma.

“We look forward to the presentation of the data from the CARTITUDE-4 study at a future medical meeting.”

The first randomised Phase III CARTITUDE-4 trial has been designed to evaluate CARVYKTI’s efficacy and safety and compares the therapy with standard of care PVd or DPd treatments in adults who received one to three lines of therapy.

The secondary endpoints of the study are overall survival, safety, minimal residual disease negative rate, and overall response rate.

Patients who are enrolled will continue to be followed for primary, secondary, and exploratory endpoints during the study duration.

The BCMA-directed, genetically modified, autologous T-cell immunotherapy CARVYKTI received approval from the US Food and Drug Administration (FDA) in February last year to treat adults with relapsed or refractory multiple myeloma.

Janssen Biotech and Legend Biotech USA signed an exclusive global license and collaboration agreement in December 2017 to develop and commercialise CARVYKTI.

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