First-in-human study of lisaftoclax (APG-2575), a novel BCL-2 inhibitor (BCL-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs).
Sikander Ailawadhi, Asher Alban Akmal Chanan-Khan, Zi Chen, Bo Huang, Marina Konopleva, Danielle M Brander, David Rizzieri, Masa Lasica, Constantine Si Lun Tam, Costas K Yannakou, H Miles Prince, Matthew Steven Davids, Zhicong He, Ming Lu, Mohammad Ahmad, Mingyu Li, Zhiyan Liang, Boyd Mudenda, Dajun Yang, Yifan Zhai
Journal of Clinical Oncology | American Society of Clinical Oncology (ASCO) | Published : 2021
7502 Background: The BCL-2i venetoclax is active in certain HMs but can increase the risk of tumor lysis syndrome (TLS), requiring a 5-week dose ramp-up for CLL patients. Cases of severe neutropenia with venetoclax treatment have also been reported. Lisaftoclax is a novel, potent, selective BCL-2i that is active against HMs and is under clinical development. Methods: This first-in-human global phase I dose study assessed the safety, PK, PD, efficacy, and MTD/RP2D of lisaftoclax in patients with R/R CLL and other HMs. Lisaftoclax was orally administered daily in a 28-day cycle. Patients with CLL or intermediate-high TLS risk were initiated on a daily ramp-up schedule until the assigned dose ..View full abstract