Singapore, 12 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 that the Safety Monitoring Committee (SMC) has completed its safety review of data from an ongoing phase 1b study of varlitinib in metastatic solid tumours. The SMC has confirmed the maximum tolerated dose (MTD) of varlitinib to be 300mg BID in combination with (i) cisplatin and 5-fluorouracil, and (ii) cisplatin and capecitabine.
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor, and is currently being developed as an experimental therapy across multiple indications including biliary tract cancer, gastric cancer, metastatic breast cancer and metastatic colorectal cancer.
The phase 1b dose-escalation study was conducted to determine the safety and early efficacy signals of varlitinib in combination with chemotherapy regimens commonly used in first line gastric cancer. ASLAN has established MTD with a wide range of standard regimens used to treat gastric cancer, biliary tract cancer, breast cancer and colorectal cancer. The study recruited 42 patients. Responses in the heavily pre-treated patients, who prior to being included in the study had received up to three lines of therapy, range from disease control to partial response, with one patient demonstrating a 87% reduction in tumour size. Eight patients with gastric cancer were enrolled in the study. Of the four patients with target lesions, one had partial response and three had stable disease as their best overall response. One patient without target lesions had stable disease as the best overall response. Varlitinib demonstrated good tolerability and the adverse events observed in the study were consistent with those observed in previous studies.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “Establishing safety and tolerability with these regimens will ultimately give physicians a broader choice in the agents they combine with varlitinib in first line gastric cancer. The clinical activity seen in gastric cancer patients in this study, together with our previously reported phase 2a data in gastric cancer, points towards meaningful clinical benefits of varlitinib and the potential to address the poor prognosis often faced by these patients.”
Interim data from the phase 1b study was recently published in an abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting which took place on 2-6 June in Chicago, Illinois.
ENDS
Media contacts
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
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 United States 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. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and colorectal cancer, and has two global pivotal studies in biliary tract cancer and gastric cancer underway. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. www.aslanpharma.com
Varlitinib is a potent, reversible, small molecule pan-HER inhibitor, and is currently being developed as an experimental therapy across multiple indications including biliary tract cancer, gastric cancer, metastatic breast cancer and metastatic colorectal cancer.
The phase 1b dose-escalation study was conducted to determine the safety and early efficacy signals of varlitinib in combination with chemotherapy regimens commonly used in first line gastric cancer. ASLAN has established MTD with a wide range of standard regimens used to treat gastric cancer, biliary tract cancer, breast cancer and colorectal cancer. The study recruited 42 patients. Responses in the heavily pre-treated patients, who prior to being included in the study had received up to three lines of therapy, range from disease control to partial response, with one patient demonstrating a 87% reduction in tumour size. Eight patients with gastric cancer were enrolled in the study. Of the four patients with target lesions, one had partial response and three had stable disease as their best overall response. One patient without target lesions had stable disease as the best overall response. Varlitinib demonstrated good tolerability and the adverse events observed in the study were consistent with those observed in previous studies.
Dr Bertil Lindmark, Chief Medical Officer, ASLAN Pharmaceuticals, said: “Establishing safety and tolerability with these regimens will ultimately give physicians a broader choice in the agents they combine with varlitinib in first line gastric cancer. The clinical activity seen in gastric cancer patients in this study, together with our previously reported phase 2a data in gastric cancer, points towards meaningful clinical benefits of varlitinib and the potential to address the poor prognosis often faced by these patients.”
Interim data from the phase 1b study was recently published in an abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting which took place on 2-6 June in Chicago, Illinois.
ENDS
Media contacts
Chris Fang
ASLAN Pharmaceuticals
Tel: +886 2 2758 3333
E-mail: media@aslanpharma.com
Emma Thompson / Stephanie Tan
Spurwing Communications
Tel: +65 6340 7287
Email: ASLAN@spurwingcomms.com
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 United States 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. The Company is developing 5 drugs addressing multiple indications including biliary tract cancer, gastric cancer and colorectal cancer, and has two global pivotal studies in biliary tract cancer and gastric cancer underway. ASLAN’s partners include Array BioPharma, Bristol-Myers Squibb, Almirall and CSL. www.aslanpharma.com
