Johnson & Johnson (JNJ.US) and Legend Biotech (LEGN.US) jointly announced the positive results of the second planned interim analysis of the phase III CARTITUDE-4 study on July 3. The study evaluated the chimeric antigen receptor (CAR) T therapy Carvykti developed by both parties compared to standard therapy for the treatment of relapsed or lenalidomide-resistant multiple myeloma (MM) patients who have undergone 1st-line treatment. The interim analysis showed statistically and clinically significant improvement in overall survival (OS) of patients treated with Carvykti compared to standard therapy.
Detailed data will be released at the upcoming medical conference and submitted to global regulatory authorities. Carvykti is the first B-cell maturation antigen (BCMA) targeting CAR-T therapy approved for second-line or higher treatment of multiple myeloma patients.
Data shows that Carvykti is a CAR-T cell therapy targeting BCMA, which modifies the patient's own T-cells with transgenic chimeric antigen receptors to identify and eliminate cells expressing BCMA. BCMA is mainly expressed on the surface of malignant multiple myeloma B cells, late-stage B cells, and plasma cells. The CAR protein of Carvykti has two single domain antibodies targeting BCMA with high affinity for cells expressing BCMA. After binding to cells expressing BCMA, CAR can promote T-cell activation and expansion, and then clear target cells.
The therapy was approved by the FDA in April of this year for the treatment of relapsed or refractory multiple myeloma adult patients who have previously received at least first-line treatment including proteasome inhibitors (PI) and immunomodulatory drugs (IMiD) and are resistant to lenalidomide.