Saad Usmani, MD, FACP, Division Chief of Plasma Cell Disorders and Director of Clinical Research in Hematological Malignancies at Levine Cancer Institute, discusses follow-up data from the CARTITUDE-1 trial presented at ASCO 2021.
Multiple myeloma is a blood cancer associated with uncontrolled growth of plasma cells. Abnormal plasma cells – also known as myeloma cells – interfere with the production of healthy blood cells in the bone marrow. Myeloma cells also produce inactive clones of abnormal antibodies that may negatively affect the bones and kidneys. Symptoms of multiple myeloma may include: bone pain (particularly in the chest and spine), frequent infections, weakness or numbness in the legs, fatigue, confusion, excessive thirst, and constipation. While the disease is treatable, relapses are common and some patients are refractory to first line treatment.
As Dr. Usmani explains, the CARTITUDE-1 study is an ongoing Phase 1b/2, open-label, multi-center study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma. Follow-up data was presented at ASH 2020 when the median length of follow-up was 12 months. Dr. Usmani presented additional follow-up data more recently at ASCO 2021 when the median length of follow-up was 18 months. The 18-month data demonstrated that in the 97 patients reported on, the overall response rate was 98% and the stringent complete response was 80.4%. The 18-month progression-free survival rate was 66% and the 18-month overall survival was 81%.
Dr. Usmani also notes that the longer follow-up did not reveal any new safety concerns with cilta-cel.
Cilta-cel as a treatment from relapsed and/or refractory multiple myeloma patients is currently under review by the FDA. They are set to make a decision by November 29, 2021.
To learn more about multiple myeloma, visit our Multiple Myeloma Learning Page.
Usmani SZ, Berdeja JG, Madduri D, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) therapy, in relapsed/refractory multiple myeloma (R/R MM): Updated results from CARTITUDE-1. J Clin Oncol. 2021,39(suppl 15; abstr 8005). Retrieved from https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.8005