Thomas Martin, MD, UCSF Helen Diller Family Comprehensive Cancer Center, discusses 2-year results from the CARTITUDE-1 study evaluating cilta-cel in heavily pre-treated, relapsed/refractory multiple myeloma patients.
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. Martin 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. Patients received a single cilta-cel infusion (target dose 0.75×106 CAR+ viable T cells/kg) 5–7 days after lymphodepletion. Primary objectives of the study were to characterize cilta-cel safety confirm the recommended dose, and to evaluate efficacy.
Previous data was presented at the American Society of Hematology Meeting & Exposition in 2020 (ASH 2020) when the median length of follow-up was 12 months. More recently, additional follow-up data was presented at ASH 2021, when the median length of follow-up was 18 months. This 2-year follow-up data demonstrated that in the 97 patients reported on, the overall response rate was 98% and the stringent complete response was 83% (compared to 67% at 12-month follow-up). The median progression-free survival was not estimable but, according to Dr. Martin, was approximately 61%.
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 February 28, 2022.
To learn more about multiple myeloma, visit our Multiple Myeloma Learning Page.