Posted: Friday, June 17, 2022
Lisaftoclax, a novel BCL2 inhibitor, appears to be well tolerated with no significant or unmanageable side effects reported for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to findings presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7543). According to Jianyong Li, MD, PhD, of Jiangsu Province Hospital, Nanjing, China, and colleagues, the treatment offers an alternative for patients with hematologic malignancies and a daily ramp-up schedule that may be more convenient for patients.
In this open-label phase Ib/IIstudy, the authors enrolled 45 patients with relapsed or refractory CLL or SLL. Three groups, consisting of 15 patients each, received 400-, 600-, or 800-mg daily doses of lisaftoclax every 28 days.
At the data cutoff, a preliminary pharmacokinetics profile of the patients revealed that exposures increased as lisaftoclax doses rose from 400 mg to 800 mg. A total of 42 patients experienced any-grade treatment-related adverse events, including neutropenia (55.6%), anemia (42.2%), and decreased leukocyte count (40%). The authors found that 28 patients (62.2%) experienced grade 3 or higher adverse events, and 13 patients (28.9%) had serious adverse events. Of those events, 25 and 9, respectively, were related to lisaftoclax, and 14 events (31.1%) led to treatment discontinuation. One case of clinical tumor-lysis syndrome was reported.
According to the study investigators, of the 41 evaluable patients with CLL, 1 achieved a complete response, and 27 with CLL and SLL achieved a partial response to treatment, for an objective response rate of 68.29%. The recommended phase II dose of lisaftoclax monotherapy is 600 mg.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.