ASH 2020: Ciltacabtagene Autoleucel Under Study in Resistant Myeloma
Posted: Friday, December 18, 2020
A single low-dose infusion of ciltacabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy, appears to lead to early, deep, and durable responses among patients with multiple myeloma who have not responded to several previous therapies. Ciltacabtagene autoleucel has two B-cell antigen-targeting antibodies designed to confer avidity to multiple myeloma cells. These results from the CARTITUDE-1 trial were presented by Deepu Madduri, MD, of Mount Sinai Medical Center in New York, and colleagues at the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 177).
This trial enrolled 97 patients who had received a median of 6 prior treatment regimens. Most patients (97.9%) were refractory to their most recent line of therapy. Patients were first administered cyclophosphamide and fludarabine every day for 3 days to achieve lymphodepletion. Between 5 and 7 days later, they received a single infusion of ciltacabtagene autoleucel.
At the time of data cutoff in May 2020, the median follow-up duration was 8.8 months. The overall response rate was 94.8%, with a complete response rate of 55.7% and a very good partial response rate of 32.0%. The median time to first response was 1.0 month, and the median time to complete response was 1.9 months, with responses deepening over time. A total of 52 patients were evaluable for minimal residual disease, and 94.2% achieved minimal residual disease negativity. The median progression-free survival and overall survival have not yet been reached; however, the 6-month progression-free survival rate was 87.4%, and the 6-month overall survival rate was 87.4%.
Ten patients died on the study, with eight due to adverse events, both related and unrelated to the study therapy. Deaths were caused by hemophagocytic lymphohistiocytosis, neurotoxicity, respiratory failure, sepsis, septic shock, pneumonia, lung abscess, acute myeloid leukemia, and progressive disease. Common adverse events noted in more than 70% of patients included cytokine-release syndrome, neutropenia, anemia, and thrombocytopenia. CAR T-cell–related neurotoxicity occurred in 20.6% of patients.
Disclosure: For a full list of authors’ disclosures, visit ash.confex.com.