Lisocabtagene Maraleucel for Resistant CLL: Phase I Trial Update
Posted: Wednesday, January 13, 2021
The chimeric antigen receptor T-cell therapy lisocabtagene maraleucel seems to be effective in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), even those who are refractory to both a Bruton’s tyrosine kinase (BTK) inhibitor and venetoclax, according to 18-month follow-up results from a phase I study. This immunotherapy demonstrated high response rates and high rates of undetectable minimal residual disease (MRD). William Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston, and colleagues presented their results at the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 546).
“Responses were rapid and durable, with lisocabtagene maraleucel detectable for up to 18 months postinfusion [in 4 of 11 patients],” the authors wrote. A phase II monotherapy study has begun enrolling patients.
The phase I monotherapy cohort included 23 patients with relapsed or refractory CLL/small lymphocytic lymphoma. Patients had received at least two previous therapies. The median number of previous therapies was six, and 83% of patients had high-risk disease. Patients received 3 days of fludarabine and cyclophosphamide for lymphodepletion, then a lisocabtagene maraleucel infusion at either dose 1 (50 × 106 cells) or dose 2 (100 × 106 cells).
The overall response rate was 82% (18 of 22 patients were evaluable for efficacy). Patients refractory to both a BTK inhibitor and venetoclax had a similar overall response rate: 80% (8 of 10 patients). Of the 20 patients evaluable for MRD, 15 (75%) had undetectable MRD in the blood and 13 (87%) also had undetectable MRD in the bone marrow. A total of 60% of patients had even reached undetectable MRD in the bone marrow by day 30. In patients who achieved a response, the median duration of response was not reached after a median follow-up of 18 months.
Disclosure: The study authors’ disclosures may be found at ash.confex.com.