ASLAN Pharmaceuticals, a Singapore based clinical-stage oncology and immunology focused biopharma company, has signed an agreement with the Korean Cancer Diagnosis & Treatment Enterprise (K-MASTER) to investigate varlitinib in a phase 1b/2 multi-centre umbrella study to evaluate the safety and efficacy of varlitinib in combination with weekly paclitaxel as a second-line treatment in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients.

K-MASTER, operated by Korea University, is funded by the South Korean government to support three key goals: genomic sequencing of cancers, clinical trials for South Korean cancer patients, and the development of a cancer genomics database. K-MASTER is already involved in 16 clinical trials, which include testing new drugs targeted at specific cancer mutations.

The two-part, phase 1b/2, open label, multi-centre study will recruit approximately 400 patients, divided between four experimental arms and a common control arm based on biomarker profiling. Patients that are HER1/HER2 co-expressing will receive varlitinib in combination with weekly paclitaxel. Other arms will test PD1 and PI3K-beta inhibitors. The study, led by Professor Sun Young Rha of the Yonsei Cancer Center, will be conducted in up to 10 sites in South Korea. 

The primary objective of the phase 1b study is to determine the maximum tolerated dose and the recommended phase 2 dose of the varlitinib and paclitaxel combination. The phase 2 part of the study will evaluate the treatment effect of the varlitinib and paclitaxel combination on progression free survival (PFS) in subjects with HER1 and HER2 co-expression in advanced or metastatic gastric cancer. ASLAN has previously conducted studies of varlitinib in first-line gastric cancer patients where there was a trend towards a clinical benefit in patients treated with varlitinib. 

Dr Chih-Yi Hsieh, Chief Medical Officer of ASLAN Pharmaceuticals, said: “The current prognosis of patients with advanced gastric cancer remains poor, even in countries like Korea where screening is widely performed. There is a clear need for new therapeutic agents to improve treatment outcomes and the survival of patients. Varlitinib is a potent inhibitor of HER1 and HER2, which are often over-expressed in gastric cancer, and we are delighted that it has been identified by the prestigious K-MASTER group as a promising new treatment for second-line gastric cancer in this ground breaking study.”