Zai Lab announces completion of ZL-2306 study for ovarian cancer patients
Zai Lab announced the early completion of an open-label study to evaluate the pharmacokinetic, or PK, profile of ZL-2306 made in China in Chinese ovarian cancer patients. The study demonstrated comparable PK profile of Chinese patients who were administered ZL-2306 to the PK profile of patients evaluated in Tesaro's clinical trials using product manufactured outside of China. These results are important in supporting the regulatory review of ZL-2306, a potent and highly selective PARP1/2 inhibitor, in ovarian cancer patients in mainland China. The open-label PK Study enrolled 36 subjects with dose levels ranging from 100mg, 200mg and 300mg, and assessed the PK profile of ZL-2306 made in China. The objective was to evaluate ZL-2306's PK profile and tolerability in Chinese patients, and to compare the key PK parameters with global data. The results showed that the drug exposure increased proportionally from 100mg to 300mg, with no unexpected safety issues noted. All key PK parameters were comparable to those in global studies. The population PK data and analysis showed no ethnicity differences between Chinese and non-Chinese patients.