Early Study of Lisocabtagene Maraleucel Plus Ibrutinib in Resistant CLL
Posted: Friday, January 8, 2021
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues conducted a study to assess the efficacy and safety of lisocabtagene maraleucel plus ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Their research, presented at the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 544), demonstrated that this combination has anticancer activity with manageable safety.
A total of 19 patients from the phase I/II TRANSCEND CLL 004 study were enrolled. All patients had experienced disease progression; they had high-risk features and received ibrutinib for at least 6 months with less-than-a-complete response, had a Bruton’s tyrosine kinase (BTK) or PLCγ2 gene mutation, and/or had received ibrutinib with no contraindication to reinitiating it. Participants received ibrutinib through leukapheresis for 90 or more days after lisocabtagene maraleucel infusion, which was performed after 3 days of lymphodepletion with fludarabine/cyclophosphamide at a dosage of 50 x 106 (dose level 1) or 100 x 106 (dose level 2) chimeric antigen receptor–positive T cells.
Patients had a median of four prior therapies, and 95% had high-risk cytogenetics. Prior to ibrutinib, 74% received a BTK inhibitor, and 53% were administered venetoclax.
Neutropenia, anemia, and febrile neutropenia of at least grade 3 occurred in 89%, 47%, and 26% of evaluable patients, respectively. A total of six patients in dose level 2 had infections. Diarrhea, hypertension, rash, and atrial fibrillation affected seven, four, one, and one patient, respectively. Cytokine-release syndrome and neurologic events occurred in 74% and 32% of patients, respectively, and seven patients required corticosteroids and/or tocilizumab. Overall response was reported in 95% of patients, and 83% maintained that response after 3 months. Undetectable minimal residual disease was achieved in 89% of participants.
Disclosure: For full disclosures of study authors, visit ash.confex.com.