ASLAN Pharmaceuticals announced the completion of patient enrolment in TreeTopp (TREatmEnT OPPortunity), a global pivotal study investigating varlitinib in second-line biliary tract cancer (BTC). Topline data is expected in the second half of 2019. TreeTopp is a randomised, double-blind, placebo-controlled clinical trial in second-line BTC comparing varlitinib and capecitabine to placebo and capecitabine. It is the large global, placebo-controlled study in BTC conducted to date. Currently, there are no approved targeted therapies for the treatment of BTC which affects more than 200,000 people in Asia every year. The study recruited 127 patients who have failed first line therapy from 56 sites worldwide including the US, Europe, Australia, Japan, Korea and other Asia Pacific countries. The co-primary endpoints of the study are objective response rate and progression free survival. The trial will meet its primary objective if either endpoint is significant at the one-sided 5% level or if both endpoints are significant at the one-sided 10% significance level. If the study results are positive, ASLAN intends to submit a New Drug Application to the US Food and Drug Administration (FDA) for an accelerated approval in second-line BTC.