Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, and AstraZeneca AB (publ) (“AstraZeneca”) have completed enrolment in a global Phase II study of savolitinib (AZD6094), a potent and highly selective mesenchymal epithelial transition factor (“c-Met”) inhibitor. This is a Phase II study to evaluate the efficacy and safety of savolitinib monotherapy (600 mg once daily) in papillary renal cell carcinoma (“PRCC”) in the United States, Canada and Europe. PRCC represents about 14% of all new cases of kidney cancer.
Savolitinib is a potential global first-in-class inhibitor of c-Met, receptor tyrosine kinase, an enzyme which exhibits aberrant behaviour (e.g. gene amplification, over-expression and mutation) in many types of solid tumours. Savolitinib was developed as a potent and highly selective oral c-Met inhibitor that was designed to address renal toxicity, the primary issue that has to-date prevented other selective c-Met inhibitors from gaining regulatory approval. In Phase I/Ib clinical studies, savolitinib has shown promising signs of clinical efficacy, causing tumour size reduction, in c-Met aberrant patients in PRCC, non-small cell lung cancer, colorectal cancer and gastric cancer.
This Phase II study is an open-label, single-arm, multicentre study designed to evaluate the efficacy and safety of savolitinib in patients with locally advanced or metastatic PRCC. A total of 90 patients have been enrolled in 22 centres, making it the largest prospective clinical study in PRCC ever conducted. The primary objective of this study is to assess the anti-tumour activity of savolitinib in patients with PRCC, with secondary assessment objectives including progression free survival, duration of response, safety and tolerability and pharmacokinetics and pharmacodynamics. Importantly, tumour samples from each patient are concurrently being subjected to molecular analysis to determine c-Met status in order to better understand the relationship between c-Met aberration and clinical outcome.
The interim data of the Phase II trial is expected to be published at the American Society of Clinical Oncology meeting in 2016.