Papillary renal cell carcinoma (PRCC) is the most common of the non-clear cell renal cell carcinomas (RCCs), accounting for 10–15% of RCCs. However, there are no therapies approved specifically for patients with PRCC, who currently receive treatments approved for clear cell RCC, such as sunitinib. PRCC is often MET-driven (defined as MET kinase domain mutations, MET amplification, chromosome 7 gain and/or HGF amplification). Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor which demonstrated anti-tumour activity for patients with MET-driven PRCC in a phase II trial.
SAVOIR (NCT03091192) is a global, phase III, open-label, randomised, controlled trial evaluating the efficacy and safety of savolitinib, compared with sunitinib, in patients with MET-driven, unresectable, locally advanced or metastatic PRCC. Approximately 180 patients will be randomised at ∼50–75 sites across 5–10 countries. Eligible patients (aged ≥18 with MET-driven PRCC confirmed by a novel, sponsor designated, validated, targeted next-generation sequencing assay; a Karnofsky performance status ≥80; and measurable disease at baseline) will be randomised in a 1:1 ratio to receive either continuous savolitinib 600 mg (400 mg if
Clinical trial identification
Clinical trial registration number: NCT03091192
Legal entity responsible for the study
T.K. Choueiri: Ad boards: AstraZeneca, Bayer, Bristol-Myers Squib, Cerulean, Eisai, Foundation Med. Inc., Genetech, GSK, Merck, Novartis, Peloton, Pfizer, Prometheus Labs, Roche, Eisai; Funding: AstraZeneca, Bristol-Myers Squib, Exelixis, Genentech, GSK, Merck, Novartis, Peloton, Pfizer, Roche, Tracon, Eisai; Travel. R. Jakacki, M.M. Frigault, L. Ottesen: Employed by AstraZeneca. D. Ghiorghiu, V. Haddad, A. Kohlmann: Employee and shareholder- AstraZeneca