Clinical Trials

Johnson & Johnson Innovative Medicine (formerly Janssen) has announced the long-term phase 3 results from its CARTITUDE-4 study, which evaluated treatment CARVYKTI in patients with relapsed or lenalidomiderefractory multiple myeloma after one prior line of therapy.

CARVYKTI is a BCMAdirected, genetically modified autologous T-cell immunotherapy. As BCMA is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells, the CARVYKTI CAR protein features two BCMA-targeting single domains designed to bind to the BCMA-expressing cells and promote T-cell activation, expansion and elimination of target cells.

CARTITUDE-4 compared CARVYKTI with standard therapies of pomalidomide, bortezomib and dexamethasone (PVd,) or daratumumab, pomalidomide and dexamethasone (DPd). At a 30-month follow up, overall survival (OS) rates were 76% for patients on the CARVYKTI arm and 64% for patients on the standard therapy arm.

Jordan Schecter MD, vice president and disease area leader, Multiple Myeloma, Innovative Medicine, Johnson & Johnson, stated: “CARVYKTI is the first and only cell therapy approved for the treatment of patients with myeloma as early as second line, and now also the first and only cell therapy to improve OS and demonstrate improved patient quality-of-life outcomes vs standard therapies for patients with lenalidomiderefractory multiple myeloma. At Johnson & Johnson, we remain committed to addressing unmet need through the development of innovative treatments for patients and healthcare providers, and we look forward to submitting these results to local health authorities worldwide.”

Multiple myeloma, also known as myeloma, is a type of bone marrow cancer. Multiple myeloma often affects several areas of the body, such as the spine, skull, pelvis and ribs.