Dr. Ailawadhi on the Safety Profile of Lisaftoclax in CLL

Sikander Ailawadhi, MD, consultant, Division of Hematology/Oncology, Department of Internal Medicine, professor of medicine, Division of Hematology/Oncology, Departments of Medicine and Cancer Biology, Mayo Clinic, discusses the safety profile of lisaftoclax in chronic lymphocytic leukemia (CLL).

During the 2021 ASCO Annual Meeting, findings from a first-in-human study of the novel BCL-2 inhibitor lisaftoclax were presented, demonstrating an 80% overall response rate in patients with relapsed/refractory CLL and small lymphocytic lymphoma.

Regarding safety, no dose-limiting toxicities were observed with up to 1,200 mg/day of lisaftoclax, says Ailawadhi. Any-grade adverse effects (AEs) were observed in 75% of patients and consisted of fatigue (n = 10; 27.8%), neutropenia (n = 8; 22.2%), diarrhea (n = 7; 19.4%), anemia (n = 6; 16.7%), constipation (n = 4; 11.1%), and nausea (n = 4; 11.1%), Ailawadhi explains. Grade 3 or higher AEs were rare and included neutropenia (n = 5; 13.9%), nausea (n = 2; 5.6%), and decreased platelet counts (n = 2; 5.6%).

Notably, no cases of laboratory or clinical tumor lysis syndrome were observed with lisaftoclax, Ailawadhi says. This suggests that lisaftoclax could offer patients a novel treatment approach that doesn’t require hospitalization or slow dose-escalation, concludes Ailawadhi.