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Topline data from largest global, placebo-controlled study in second line biliary tract cancer expected in the second half of 2019


Singapore, 2 January 2019 – ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today 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 largest 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.


Dr Mark McHale, Chief Operating Officer of ASLAN Pharmaceuticals, said: “TreeTopp has generated strong levels of interest from the international oncology community, which enabled us to recruit patients into the study ahead of our timeline and demonstrates the clear need for a new therapy to treat BTC, a cancer that is often diagnosed at an advanced stage with limited treatment options and poor survival rates.”


Varlitinib is a potent, reversible, small molecule pan-HER inhibitor currently in development across multiple indications including biliary tract, gastric, metastatic breast and metastatic colorectal cancers. It has previously demonstrated tumour shrinkage responses and durable disease stabilization in BTC patients in a phase 1b study and has obtained Orphan Drug Designation (ODD) from the US FDA for BTC and the Ministry of Food and Drug Safety in South Korea.


ASLAN will present new safety and efficacy data from its ongoing multicentre phase 1b/2 study of varlitinib plus gemcitabine and cisplatin in first line BTC at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on Friday, 18 January 2019 in San Francisco. Data from a pooled analysis of three phase 1 studies of varlitinib in combination with platinum-based regimens in BTC will also be presented at the same conference.

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Last Updated: 04-Jan-2019