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news.Chi-Med and AstraZeneca have commenced a phase 3 study of their c-MET receptor tyrosine kinase inhibitor savolitinib for the treatment of papillary renal cell carcinoma (PRCC).
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Dubbed SAVOIR, the phase 3 trial will be held globally in five to ten countries to assess the efficacy and safety of savolitinib in comparison with sunitinib.
The open-label, randomized, controlled trial will feature about 180 patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC.
Chi-Med CEO Christian Hogg said: “The launch of the SAVOIR trial, designed to support product registration in the U.S. 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.
“We also expect to further understand the correlations between c-MET alterations and patient outcomes through epidemiological analyses using our newly developed companion diagnostic assay.”
Patients will be equally randomized in the phase 3 trial to either receive continuous oral treatment with 600mg of savolitinib once daily, or intermittent oral treatment with 50mg of sunitinib once daily (4 weeks on/2 weeks off), on a 6-week cycle.
The main objective of the SAVOIR trial is to measure the primary endpoint which will be progression free survival of savolitinib in comparison with sunitinib.
Secondary endpoints on the other hand will feature overall survival, objective response rate, best percentage change in tumor size, duration of response, disease control rate, along with safety and tolerability.
AstraZeneca IMED Oncology SVP 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.”
Following the initiation of the SAVOIR trial, Chi-Med’s subsidiary Hutchison MediPharma has bagged a milestone payment of $5m from AstraZeneca.
The payment was in connection with a license and collaboration agreement signed between Hutchison and AstraZeneca in 2011.