Zai Lab presents results of PK study for ZL-2306.
Zai Lab (ZLAB) presented results of its open-label study to evaluate the pharmacokinetic, or PK, profile of ZL-2306 made in China in Chinese ovarian cancer patients. Results from the study show comparable PK profile of the Chinese patients administered ZL-2306 to that of patients evaluated in Tesaro's (TSRO) global PK study. These data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology, or CSCO. The open-label PK Study enrolled 36 Chinese patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients had received no more than two lines of platinum-based therapy and were responsive to the most recent platinum-based treatment. Subjects were randomly assigned to dose levels of 100mg, 200mg and 300mg. The primary objective of the study was to assess the PK profile of ZL-2306 in Chinese patients following both single and multiple doses. The secondary objective was a safety assessment. There were no unexpected safety issues noted during the trial. All key PK and safety parameters were comparable to those in global studies. The study results and population PK data did not identify ethnicity differences between Chinese and non-Chinese patients. The positive outcome of this PK study will further enhance ZL-2306 application package in China.