Biopharmaceutical firm Hutchison China MediTech (Chi-Med) has begun a Phase II clinical trial of savolitinib for the treatment of locally advanced or metastatic pulmonary sarcomatoid carcinoma (PSC) in China.
Savolitinib is developed as a selective oral inhibitor of mesenchymal epithelial transition factor (c-Met) receptor of an enzyme tyrosine kinase, which was reported to have abnormal functionality in several types of solid tumours.
The multi-centre, single-arm, open-label Phase II trial will evaluate the efficacy and safety of savolitinib as a monotherapy in patients harbouring Met gene alterations.
The trial's primary endpoint is objective response rate (ORR), while secondary endpoints include progression free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS) and safety.
The drug was reported to have shown encouraging results of clinical efficacy in Phase I trial. It was found to decrease the tumour size in patients with c-Met gene amplification in papillary renal cell carcinoma, non-small-cell lung cancer, colorectal cancer and gastric cancer.
The firm is currently evaluating savolitinib in collaboration with AstraZeneca, in several parallel proof-of-concept studies as a monotherapy and in combination with other targeted therapies, immunotherapies and chemotherapy.
Chi-Med has recently initiated a Phase I clinical trial of small molecule inhibitor HMPL-453 in Australia, to treat advanced or metastatic solid malignancies.
The open-label, dose-escalation Phase I trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of HMPL-453.
