Dr. Ailawadhi on the Efficacy of Lisaftoclax in Hematologic Malignancies

Sikander Ailawadhi, MD, professor of medicine, Division of Hematology/Oncology, Departments of Medicine and Cancer Biology, Mayo Clinic, discusses the activity of lisaftoclax in patients with hematologic malignancies.

Lisaftoclax was evaluated in patients with relapsed/refractory CLL and other hematologic malignancies, including non-Hodgkin lymphoma, multiple myeloma, myeloid malignancies, and hairy cell leukemia. In the phase 1 study (NCT03537482), patients received the oral BCL-2 inhibitor daily in 28-day cycles. Patients with a non-CLL hematologic malignancy and a low risk for tumor lysis syndrome (TLS) were grouped into cohort A and started on an assigned dose without a daily ramp-up. Patients with CLL/small lymphocytic lymphoma or intermediate-high risk of TLS were grouped into cohort B and started on a daily ramp-up schedule until the assigned dose. Doses ranged from 20 mg to 1200 mg.

The results of the study, which were presented during the 2021 ASCO Annual Meeting, indicated that among 15 patients with a high risk for TLS, 80% had an overall response to the agent. These findings are very encouraging given that this is the first-in-human study of the agent, says Ailawadhi. Among patients with a low risk for TLS, investigators reported a stable disease rate of 42.9% even with lower doses than the recommended phase 2 dose, indicating that the agent can elicit disease stabilization across a range of hematologic malignancies, concludes Ailawadhi.