The invited discussant of the phase I trial of lisaftoclax (APG-2575), Jacqueline C. Barrientos, MD, of Hofstra/Northwell, Great Neck, New York, commented on the positive findings: “The 15 patients with chronic lymphocytic leukemia [CLL] had an objective response rate of 80% and a median time to response of two cycles, with a favorable safety profile. Only two discontinuations were related to toxicity, and there was no evidence of laboratory or clinical tumor-lysis syndrome. Grade 3 and 4 adverse events were infrequent.”
Jacqueline C. Barrientos, MD
The lack of evidence of tumor-lysis syndrome is important. “From a historical perspective, in the first-in-human trial of venetoclax, there were three cases of laboratory tumor-lysis syndrome, and two patients died of it in subsequent trials, necessitating a reduction in the recommended dose and schedule,” Dr. Barrientos reminded listeners.
“APG-2575 is a promising new agent for CLL and has clinical activity in other hematologic malignancies, with a rapid response and shorter daily ramp-up schedule time [than venetoclax]. Its favorable safety profile is another advantage,” she noted.
DISCLOSURE: Dr. Barrientos has received honoraria from Janssen; has served as a consultant or advisor to AbbVie, AstraZeneca, BeiGene, Genentech, Gilead Sciences, Innate Pharma, and Pharmacyclics; and has received institutional research funding from AstraZeneca, Oncternal Therapeutics, and Pharmacyclics.
The novel, selective BCL2 inhibitor lisaftoclax (APG-2575) has shown activity in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in a phase I study reported at the 2021 ASCO Annual Meeting.1 Preliminary data suggest that lisaftoclax stands out for its favorable safety...