AstraZeneca and Chi-Med begin Phase III trial of savolitinib for PRCC
AstraZeneca and Hutchison China MediTech (Chi-Med) have started a Phase III SAVOIR clinical trial of savolitinib to treat patients with papillary renal cell carcinoma (PRCC).
Savolitinib is an oral, highly selective inhibitor of c-MET receptor tyrosine kinase enzyme found in various solid tumours.
The global, open-label, randomised, multi-centre, controlled, registration Phase III trial is designed to assess the safety and efficacy in around 18 patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC, when compared with sunitinib.
Set to be conducted at 50 to 75 centres across five to ten countries, the trial will involve administration of continuous 600mg once a day savolitinib or 50mg once-daily sunitinib on a six-week cycle.
Chi-Med CEO Christian Hogg said: "The launch of the SAVOIR trial, designed to support product registration in the US and Europe, continues to advance our strategy to deliver innovative medicines to major markets worldwide.
"Based on the results of our Phase II study, we believe savolitinib has the potential to bring meaningful clinical benefit to patients with c-MET-driven PRCC."
The primary objective of the trial is primary efficacy endpoint progression-free survival, while secondary endpoints are overall survival, objective response rate, duration of response, best percentage change in tumour size, disease control rate, safety, and tolerability.
AstraZeneca IMED Oncology senior vice-president Susan Galbraith said: "The data building across our early development studies are encouraging, that savolitinib has the potential to be an important treatment option for c-MET driven cancers including kidney, lung and gastric cancers."
Under a licence and collaboration agreement signed between the firms in 2011, the Phase III trial start has triggered a $5m milestone payment from AstraZeneca to Chi-Med’s division Hutchison MediPharma.