Carvykti(Ciltacabtagene Autoleucel):A Breakthrough in CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma
Carvykti(Ciltacabtagene Autoleucel):A Breakthrough in CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma
Legend Biotech and Janssen Biotech Inc. entered into a collaboration agreement in December 2017 to co-develop a gene therapy product called Ciltacabtagene Autoleucel (Carvykti).
Carvykti is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed or refractory multiple myeloma (R/R MM).
Carvykti
In February 2022, Carvykti received approval from the U.S. FDA, and in May of the same year, it received conditional approval from the European Union, becoming the first China-produced CAR-T cell therapy drug to be approved by the U.S. FDA. On January 2, 2023, Legend Biotech announced that the National Medical Products Administration (NMPA) of China had officially accepted the New Drug Application (NDA) for Carvykti.
Carvykti Global Approval Timeline
Global Approval Timeline for Carvykti
Mechanism of Action
Carvykti is a BCMA-directed, autologous, transgenic T-cell immunotherapy. It involves genetically modifying a patient’s own T cells to encode a chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells expressing BCMA.
BCMA is primarily expressed on the surface of malignant multiple myeloma B cells, as well as late-stage B cells and plasma cells.
The Carvykti CAR protein contains two BCMA-binding domains designed to confer high avidity for human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, proliferation, and elimination of target cells.
How carvykti works
Safety Evaluation
According to the results of the pivotal Phase 1b/2 CARTITUDE-1 study, which enrolled 97 patients who had previously received a median of six lines of therapy (range 3-18), including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 antibodies, patients receiving a single infusion of Carvykti demonstrated deep and durable responses.
The overall response rate (ORR) was 96.9%, with 65 patients achieving a stringent complete response (sCR), resulting in a sCR rate of 67%.
At a median follow-up of 18 months, the median duration of response (DOR) was 21.8 months.
Among 106 patients treated with Carvykti, 105 (99.1%) experienced adverse events, with the most common being cytokine release syndrome (94.3%), cytopenias (79.2%), neutropenia (75.5%), thrombocytopenia (59.4%), anemia (51.9%), neurologic toxicities (39.6%), infections (19.8%), and hypogammaglobulinemia (11.3%).
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