ASLAN Pharmaceuticals, a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, announced the enrolment of the first patient in a global phase 2/3 study investigating varlitinib as first line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients.

Varlitinib is a potent, reversible, small molecule pan-HER inhibitor and is currently being developed across multiple indications including biliary tract, gastric, metastatic breast and metastatic colorectal cancers.

The global phase 2/3 study is a double blind, randomised two-arm study that aims to determine the efficacy of varlitinib in combination with mFOLFOX6 (a combination chemotherapy regimen) in comparison to mFOLFOX6 alone in the first-line setting. The first part of the study will enrol 40 HER1/HER2 coexpressing patients who were not exposed to prior systemic therapy and will read out in 2018.

Dr Bertil Lindmark, chief medical officer, ASLAN Pharmaceuticals, said: "This marks an important milestone for ASLAN as we treat the first patient in a further global late stage study of varlitinib, the second that we have initiated this year. Varlitinib has the potential to be an important first line therapeutic for metastatic or advance-stage gastric cancer patients who currently have very limited treatment options."

Gastric cancer currently ranks fourth in cancer incidence worldwide and is one of the most common types of cancer in Asia.

Varlitinib is also currently being investigated in a global pivotal trial in biliary tract cancer (BTC). Varlitinib has been awarded the Orphan Drug Designation (ODD) by the Korea MFDS for BTC. An ODD status was also granted by the US FDA for varlitinib in gastric cancer and cholangiocarcinoma.