Clinical lymphoma, myeloma & leukemia · 2026
Phase 1 Trial of BCL-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Other Non-Hodgkin Lymphomas.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Sun Mingyuan, Zhou Keshu, Qi Junyuan, Liu Huilan, Shen Aizong, Geng Liangquan, Zhou Fuling, Huang Jianying, Chen Zi, Zhang Ke, Men Lichuang, Cong Danhua, Lu Fang, Yang Dajun, Zhai Yifan, Wang Jianxiang
Аннотация
BACKGROUND: Lisaftoclax is a novel BCL-2 inhibitor. This phase 1 trial (NCT03913949) evaluated the safety and preliminary efficacy of lisaftoclax in Chinese patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and other non-Hodgkin lymphomas (NHL).
PATIENTS AND METHODS: Lisaftoclax was administered orally in 28-day cycles, targeting daily doses of 20-800 mg for up to 24 cycles, using a daily ramp-up to minimize tumor lysis syndrome (TLS) risk. Patients with previous resistance to a BCL-2 inhibitor or exposure to a BCL-2 inhibitor in the most recent treatment line were excluded. Among 51 enrolled patients, 14 had CLL/SLL, 13 mantle cell lymphoma (MCL), and 4 marginal zone lymphoma (MZL).
RESULTS: The maximum tolerated dose of lisaftoclax was not reached; neither dose-limiting toxicity nor TLS was observed. Common adverse events included anemia, neutropenia, and thrombocytopenia. Significant antitumor activity was observed in CLL/SLL (overall response rate [ORR] 71.4%, complete response [CR] 28.6%); MCL (ORR 50.0%, CR 20.0%); and MZL (ORR 50.0%, CR 0). Median progression-free survival was 7.9 (95% CI, 4.9-14.1) months for all patients and 18.6 (95% CI, 8.4-not reached [NR]) and 7.9 (95% CI, 2.0-NR) months for those with CLL/SLL and MCL, respectively. The median overall survival was NR (95% CI, 26.2-NR) for all patients.
CONCLUSION: Lisaftoclax has a manageable safety profile and induces durable responses in R/R CLL/SLL and NHL.
PATIENTS AND METHODS: Lisaftoclax was administered orally in 28-day cycles, targeting daily doses of 20-800 mg for up to 24 cycles, using a daily ramp-up to minimize tumor lysis syndrome (TLS) risk. Patients with previous resistance to a BCL-2 inhibitor or exposure to a BCL-2 inhibitor in the most recent treatment line were excluded. Among 51 enrolled patients, 14 had CLL/SLL, 13 mantle cell lymphoma (MCL), and 4 marginal zone lymphoma (MZL).
RESULTS: The maximum tolerated dose of lisaftoclax was not reached; neither dose-limiting toxicity nor TLS was observed. Common adverse events included anemia, neutropenia, and thrombocytopenia. Significant antitumor activity was observed in CLL/SLL (overall response rate [ORR] 71.4%, complete response [CR] 28.6%); MCL (ORR 50.0%, CR 20.0%); and MZL (ORR 50.0%, CR 0). Median progression-free survival was 7.9 (95% CI, 4.9-14.1) months for all patients and 18.6 (95% CI, 8.4-not reached [NR]) and 7.9 (95% CI, 2.0-NR) months for those with CLL/SLL and MCL, respectively. The median overall survival was NR (95% CI, 26.2-NR) for all patients.
CONCLUSION: Lisaftoclax has a manageable safety profile and induces durable responses in R/R CLL/SLL and NHL.