▎WuXiEdited by the Kant Content Team

Johnson & Johnson and Legend Biotech today jointly announced positive results from the pre-specified second interim analysis of the Phase 3 CARTITUDE-4 study, which evaluated their jointly developed chimeric antigen receptor (CAR) T-cell therapy Carvykti (ciltacabtagene autoleucel, cilta-cel) compared to standard therapy for the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma (MM) after one prior line of therapy. The interim analysis showed,Compared with the standard therapy, patients treated with Carvykti showed a statistically and clinically significant improvement in overall survival (OS).Detailed data will be presented at the upcoming medical conference and submitted to global regulatory authorities. According to the press release,Carvykti is the first B-cell maturation antigen (BCMA)-targeted CAR-T therapy approved for second-line or later treatment of patients with multiple myeloma.

▲FDA toPFS Analysis Results of the CARTITUDE-4 Trial (Image Source: Reference [2])

Carvykti is a CAR-T cell therapy targeting BCMA, which modifies the patient's own T cells with a transgene encoding a chimeric antigen receptor to identify and eliminate cells expressing BCMA.BCMA is primarily expressed on the surface of malignant multiple myeloma B cells, late-stage B cells, and plasma cells. The CAR protein of Carvykti contains two single-domain antibodies targeting BCMA, exhibiting high affinity for cells expressing BCMA. After binding to BCMA-expressing cells, the CAR promotes T-cell activation and expansion, subsequently eliminating the target cells. This therapy, in April this year,FDA Approved, for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least one prior therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are lenalidomide-resistant.

References:

[1] CARVYKTI® (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study. Retrieved July 2, 2024 from https://www.prnewswire.com/news-releases/carvykti-ciltacabtagene-autoleucel-achieved-statistically-significant-and-clinically-meaningful-improvement-in-overall-survival-in-landmark-cartitude-4-study-302187545.html

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