ASLAN Receives Clinical Trial Authorization To Initiate Pivotal Study Of Varlitinib In Gastric Cancer

Published: Jun 01, 2017

Singapore, 1 June 2017 – ASLAN Pharmaceuticals (ASLAN, 6497.TT), a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumour types, today announced receipt of clinical trial authorisation (CTA) from Singapore’s Health Sciences Authority to initiate a pivotal study of varlitinib, its lead asset, for the treatment of gastric cancer.

The placebo-controlled study will investigate the safety and efficacy of varlitinib in combination with mFOLFOX6 (a combination chemotherapy regimen) in patients with HER1/HER2 coexpressing advanced or metastatic gastric cancer without prior exposure to systemic therapy. The study is expected to commence in the third quarter of 2017 and interim data will be available in 2018. Primary outcome measures are the percentage change from baseline in tumour size at week 12 and overall survival. Secondary outcome measures will include objective response rate, progression-free survival and time to response.

Varlitnib is a potent, reversible, small molecule pan-HER inhibitor, and is currently being developed across multiple indications including biliary tract cancer, gastric cancer, metastatic breast cancer and metastatic colorectal cancer. Incidences of gastric cancer in Asia are among the highest in the world1. It is the third most common cancer after breast and lung, and is the second most common cause of cancer death after lung cancer2. It is one of the top ten most common cancers in Singapore1.

Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: “The receipt of clinical trial authorisation marks an important milestone for ASLAN and the late-stage development of varlitinib in an indication which remains a highly prevalent, yet poorly treated, disease area in Asia. This trial will be the second pivotal study that ASLAN initiates in 2017, a significant achievement for our team and for patients as we move closer to regulatory submissions for varlitinib.” Varlitinib has been awarded Orphan Drug Designation by the US Food and Drug Administration for gastric cancer.

Ends Media contact Chris Fang ASLAN Pharmaceuticals Tel: +886 2 2758 3333 E-mail:

Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287

About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a potent small molecule inhibitor of the HER-family of receptor tyrosine kinases (RTKs). The type I RTK family consists of four distinct but closely related receptors: epidermal growth factor receptor (EGFR, ErbB1, HER1), epidermal growth factor receptor 2 (HER2, ErbB2), epidermal growth factor receptor 3 (HER3, ErbB3), and epidermal growth factor receptor 4 (HER4, ErbB4). Varlitinib is a potent, reversible, small molecule inhibitor of EGFR, HER2 and HER4. In a large variety of cancers, the overexpression and/or constitutive activation of EGFR and HER2 are often observed and frequently correlate with poor clinical prognosis. Therefore, by inhibiting the activation of the HER receptors via varlitinib, effects such as shrinkage of the tumour and longer survival can be anticipated. Varlitinib is currently being studied in biliary tract, breast and gastric cancers. Varlitinib has been granted orphan drug status in the USA for cholangiocarcinoma and gastric cancer and was awarded orphan drug status for the treatment of advanced biliary tract cancer after first line systemic therapy by the Korean MFDS.

About ASLAN Pharmaceuticals ASLAN Pharmaceuticals (6497.TT) is an oncology focused biotechnology company developing a portfolio of immunotherapies and targeted drugs, focusing on Asia prevalent tumour types. Led by a highly experienced management team with global pharmaceutical expertise, ASLAN is headquartered in Singapore with a platform that reaches across the region via its offices in Taiwan, China and Australia, enabling the Company to conduct and support regional clinical development programmes. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and breast cancer. ASLAN has several compounds in late stage development: varlitinib (ASLAN001), a pan-HER inhibitor which has completed phase 2 studies in gastric and breast cancer, and is entering pivotal studies for biliary tract cancer; and ASLAN002 (partnered with BMS), a RON and cMET inhibitor in phase 2 development for gastric and breast cancer.

1 National Cancer Centre Singapore
2 Globocan. Cancer Fact Sheet

Back to news