Singapore – ASLAN Pharmaceuticals, a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, announced the presentation of new data from an ongoing phase 1 study to determine the safety, tolerability and maximum tolerated dose (MTD) of varlitinib in combination with oxaliplatin and capecitabine (COX) or oxaliplatin and 5-FU (FOL) in advanced solid tumours. The study findings, presented in a poster session at the 2018 European Society for Medical Oncology (ESMO) Congress, indicate encouraging signs of efficacy for varlitinib as a treatment for late-stage oncology patients.

The investigator-initiated trial was conducted by Dr Matthew Chau Hsien Ng and supported by ASLAN and the Singapore National Medical Research Council. The trial enrolled 30 patients with a median ECOG score of 1 and a median of 3 lines of prior chemotherapy. Patients were dosed with varlitinib and either COX or FOL for 18 weeks, after which patients continued on varlitinib monotherapy. The most commonly occurring adverse events were fatigue, anorexia and diarrhoea, with grade 3 / 4 diarrhoea occurring in 7% of patients.

Of 28 patients evaluable for response, 3 (11%) showed partial response (PR), 16 (57%) experienced stable disease (SD) and 10 (36%) patients had PR or SD continuing beyond 18 weeks. The MTD for varlitinib in combination with COX and FOL was 300mg BID administered orally. Durable efficacy was seen in patients with biliary tract cancer (BTC) and HER2 over-expressing colorectal cancer (CRC), with 7 patients having progression free survival over 24 weeks up to 92 weeks, all of whom had prior platinum exposure. As at 12 April 2018 (the cut-off date for the poster data), four patients were still on study. The full study results are expected in the first half of 2019.

Dr Mark McHale, COO of ASLAN Pharmaceuticals, said: “To see responses and durable disease control in such heavily pre-treated patients is encouraging. The early signs of efficacy we have observed in this study suggest that varlitinib has the potential to become a new treatment option for patients with late-stage biliary tract cancer and HER2 over-expressing colorectal cancer.”