ASLAN Pharmaceuticals announced the presentation of new data from a phase 1b open-label, dose escalation study of varlitinib in combination with modified irinotecan and infusional 5-fluorouracil chemotherapy to determine the safety, tolerability and maximum tolerated dose in advanced solid tumours.
Singapore, 2 October 2019 – ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology and immunology focused biopharma company, today announced the presentation of new data from a phase 1b open-label, dose escalation study of varlitinib in combination with modified irinotecan and infusional 5-fluorouracil (mFOLFIRI) chemotherapy to determine the safety, tolerability and maximum tolerated dose (MTD) in advanced solid tumours. The study findings were presented in a poster session at the 2019 European Society for Medical Oncology (ESMO) Congress.
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 16 patients with a median of 3 lines of prior chemotherapy. Patients received varlitinib twice daily (BID) at a dose of either 200mg or 300mg plus mFOLFIRI for up to 9 cycles (14 day cycles), followed by varlitinib as monotherapy from cycle 10 onwards.
The MTD of varlitinib combined with mFOLFIRI was 300mg BID administered orally. The overall response rate was 13% and median PFS was 4.2 months. Durable responses were observed in a biliary tract cancer patient (one prior line of chemotherapy) and a HER2 positive ovarian clear cell carcinoma patient (five prior lines of chemotherapy), maintained at 7.5 and 6.1 months respectively. The most commonly occurring adverse events were fatigue, oral mucositis, anorexia and grade 1/2 diarrhoea, with 0% grade 3/4 diarrhoea. As at 15 February 2019 (the cut-off date for the poster data), four patients were still on study.
The abstract can be accessed on ASLAN’s website via this link.
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About varlitinib (ASLAN001)
Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a clinical-stage oncology and immunology focused biopharma company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe. Led by a senior management team with extensive experience in global and regional development and commercialisation, ASLAN is headquartered in Singapore and has offices in Taiwan and China. ASLAN’s clinical portfolio is comprised of three product candidates which target validated growth pathways applied to new patient segments, novel immune checkpoints and novel cancer metabolic pathways. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. For additional information please visit www.aslanpharma.com.
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