Ying Huang, PhD, CEO of Legend Biotech, discusses updated results from the CARTIFAN-1 study, evaluating cilta-cel in patients in China with relapsed/refractory multiple myeloma who have received ≥3 prior lines of therapy. These data were recently presented at the American Society of Hematology Meeting & Exposition (ASH 2022).
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. Huang explains, the CARTIFAN-1 study is an ongoing Phase 2, open-label study evaluating the safety and efficacy of cilta-cel in adults in China with relapsed and/or refractory multiple myeloma who have received three or more prior lines of therapy. Patients received a single cilta-cel infusion (target dose 0.75×106 CAR+ viable T cells/kg). Primary objective of the study was overall response rate (ORR).
As of the April 19, 2022, corresponding to a median follow-up of 26.4 months (minimum 18 months), the 48 patients who had received cilta-cel had a median of 4 prior lines of therapy. 31% were triple-class exposed, 19% were triple-class refractory, and 98% were refractory to their last line of therapy. Since the last data cut (July 2021), the ORR remained at 85.4%, but responses deepened, with 79.2% of patients achieving stringent complete response. Median duration of response was not reached. Of the 41 evaluable patients, 40 were MRD negative. Median PFS and OS were not reached; 24-month PFS and OS rates were 52.6% and 74.2%, respectively. Patients who achieved sustained MRD negativity for ≥12 months had more favorable PFS than the overall population.
All patients experienced one or more grade 3/4 treatment-emergent AEs (TEAEs). The most common TEAEs were hematologic. Grade 3/4 cytopenias included neutropenia (97.9%), lymphopenia (91.7%), thrombocytopenia (54.2%), and anemia (52.1%). The overall incidence of cytokine release syndrome (97.9%), hemophagocytic lymphohistiocytosis (6.3%), CAR-T cell neurotoxicity (4.2%), and infection (85.4%) remained consistent since the previous data cut. There were no cases of parkinsonism/movement and neurocognitive TEAEs. A total of 12 deaths post cilta-cel infusion (8 considered treatment-related) were reported. At data cutoff, 36 cilta-cel-treated patients remained on study; 16 patients have remained disease-free for 24 months or more, and 1 patient for 36 months or more.
Overall these data indicate that responses to cilta-cel deepen over time and the risk-benefit profile remains favorable.
To learn more about multiple myeloma and other rare cancers, visit checkrare.com/diseases/cancers/