Legend Biotech has introduced CARVYKTI®, the pioneering BCMA-Targeted CAR-T cell therapy aimed at treating individuals with relapsed or refractory multiple myeloma who have undergone at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are resistant to lenalidomide.
CARVYKTI® stands out as the primary B-cell maturation antigen (BCMA) targeted therapy, encompassing CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs), sanctioned for use starting from the second line of treatment for multiple myeloma patients.
Ciltacabtagene autoleucel, the core of CARVYKTI®, is a BCMA-directed, genetically modified autologous T-cell immunotherapy. It entails reprogramming the patient's own T-cells with a transgene encoding a chimeric antigen receptor (CAR) capable of identifying and eradicating BCMA-expressing cells.
The CAR protein within cilta-cel comprises two BCMA-targeting single domain antibodies, meticulously designed to possess high avidity against human BCMA. Once bound to BCMA-expressing cells, the CAR triggers T-cell activation, proliferation, and the eradication of target cells.
With an expanded label, CARVYKTI® has the potential to revolutionize the treatment approach for multiple myeloma, offering patients and healthcare providers a tailored immunotherapy option that can be implemented earlier in the treatment sequence.
FDA approval for CARVYKTI® was based on positive results from the CARTITUDE-4 study, demonstrating significant improvements in progression-free survival compared to standard regimens PVd or DPd in adults with relapsed and lenalidomide-refractory multiple myeloma. The study highlighted cilta-cel's clinical advantages over continuous standard care for patients experiencing relapse after one to three prior treatments.
Given the incurable and progressive nature of multiple myeloma, which often leads to treatment resistance and relapse, the introduction of innovative options like CARVYKTI® is crucial to address the pressing needs of patients.
