Clinical Research Papers:
Puquitinib mesylate, an inhibitor of phosphatidylinositol 3-kinase p110δ, for treating relapsed or refractory non-Hodgkin’s lymphoma
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Hang Yang1,2,*, Yu Wang1,2,*, Jing Zhan1,3, Yi Xia1,2, Peng Sun1,2, Xi-Wen Bi1,2, Pan-Pan Liu1,2, Zhi-Ming Li1,2, Su Li1,3, Ben-Yan Zou1,4, Wen-Qi Jiang1,2
1Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China
2Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
3Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
4Nursing Department, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
*These authors have contributed equally to this work
Wen-Qi Jiang, e-mail: [email protected]
Ben-Yan Zou, e-mail: [email protected]
Keywords: XC-302, PI3K pathway, non-Hodgkin lymphoma, safety and efficacy, pharmacokinetics
Received: July 20, 2015 Accepted: September 24, 2015 Published: October 17, 2015
Objectives: To determine the safety of Puquitinib Mesylate (XC-302), an oral inhibitor of phosphatidylinositol 3-kinase, in treating relapsed or refractory non-Hodgkin’s lymphoma (NHL).
Methods: Between October 2013 and July 2015, 21 patients from Sun Yat-sen University Cancer Center were treated twice daily on each day of a 28-day cycle (median number of cycles, 2; maximum, 20) with XC-302 at a post prandial dose of 25 mg, 37.5 mg, or 50 mg. Adverse events (AEs), AUClast and Cmax, response rates, and overall survival were assessed.
Results: Patients had received a median (range) of 1 (1 to 3) previous cancer treatments. At the latest follow-up, two patients were still benefitting from the study. The most common drug-related AEs were elevations in alanine transaminase (ALT, 14 of 21 patients) and aspartate transaminase (AST, 7 of 21 patients). Four patients, both in the-50-mg group, had dose-limiting toxicities, and therapy was discontinued in a fifth because of persistent abnormal liver function. The overall response rate was 2 of19. Serum concentrations of XC-302 increased in a dose-dependent pattern. Median progression-free survival in all patients was 1.9 (95% CI, 1.7 to 2.0) months.
Conclusion: XC-302 has an acceptable safety profile and offers potential therapeutic value to patients with relapsed or refractory non-Hodgkin lymphoma.
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