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Poster display session

3903 - Savolitinib versus sunitinib in patients with MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma: SAVOIR, a randomised, phase III trial

Date

10 Sep 2017

Session

Poster display session

Presenters

Toni Choueiri

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

T.K. Choueiri1, R. Jakacki2, D. Ghiorghiu3, V. Haddad4, A. Kohlmann5, M.M. Frigault6, L. Ottesen3

Author affiliations

  • 1 Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 2 Global Medicines Development, AstraZeneca, Gaithersburg/US
  • 3 Global Medicines Development, AstraZeneca, Cambridge/GB
  • 4 Biometrics & Information Sciences, AstraZeneca, Cambridge/GB
  • 5 Personalised Healthcare And Biomarkers, AstraZeneca, Cambridge/GB
  • 6 Translational Science, AstraZeneca, San Francisco/US
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Resources

Abstract 3903

Background

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.

Trial design

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

AstraZeneca

Funding

AstraZeneca

Disclosure

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

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