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journal article May 10, 2023

Phase II Study Investigating the Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer (CALYPSO)

Cristina Suarez James M.G. Larkin Poulam Patel Begoña P. Valderrama Alejo Rodriguez-Vida ORCID Hilary Glen ORCID Fiona Thistlethwaite ORCID Christy Ralph Gopalakrishnan Srinivasan Maria Jose Mendez-Vidal ORCID Ryan Hartmaier Aleksandra Markovets Aaron Prendergast ORCID Bernadett Szabados ORCID Kelly Mousa Thomas Powles ORCID
Journal of Clinical Oncology Vol. 41 No. 14 pp. 2493-2502 · American Society of Clinical Oncology (ASCO)
View at Publisher Save 10.1200/jco.22.01414
Abstract
PURPOSE Metastatic papillary renal cancer (PRC) has poor outcomes, and new treatments are required. There is a strong rationale for investigating mesenchymal epithelial transition receptor (MET) and programmed cell death ligand-1 (PD-L1) inhibition in this disease. In this study, the combination of savolitinib (MET inhibitor) and durvalumab (PD-L1 inhibitor) is investigated. METHODS This single-arm phase II trial explored durvalumab (1,500 mg once every four weeks) and savolitinib (600 mg once daily; ClinicalTrials.gov identifier: NCT02819596 ). Treatment-naïve or previously treated patients with metastatic PRC were included. A confirmed response rate (cRR) of > 50% was the primary end point. Progression-free survival, tolerability, and overall survival were secondary end points. Biomarkers were explored from archived tissue (MET-driven status). RESULTS Forty-one patients treated with advanced PRC were enrolled into this study and received at least one dose of study treatment. The majority of patients had Heng intermediate risk score (n = 26 [63%]). The cRR was 29% (n = 12; 95% CI, 16 to 46), and the trial therefore missed the primary end point. The cRR increased to 53% (95% CI, 28 to 77) in MET-driven patients (n/N = 9/27) and was 33% (95% CI, 17 to 54) in PD-L1–positive tumors (n/N = 9/27). The median progression-free survival was 4.9 months (95% CI, 2.5 to 10.0) in the treated population and 12.0 months (95% CI, 2.9 to 19.4) in MET-driven patients. The median overall survival was 14.1 months (95% CI, 7.3 to 30.7) in the treated population and 27.4 months (95% CI, 9.3 to not reached [NR]) in MET-driven patients. Grade 3 and above treatment related adverse events occurred in 17 (41%) patients. There was 1 grade 5 treatment-related adverse event (cerebral infarction). CONCLUSION The combination of savolitinib and durvalumab was tolerable and associated with high cRRs in the exploratory MET-driven subset.
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Cited By
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Xiao-Peng Duan, Bao-Dong Qin · 2024

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Details
Published
May 10, 2023
Vol/Issue
41(14)
Pages
2493-2502
Authors
C
Cristina Suarez

Medical Oncology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain

J
James M.G. Larkin

The Royal Marsden Hospital, London, United Kingdom

P
Poulam Patel

Nottingham University Hospital NHS Trust, Nottingham, United Kingdom

B
Begoña P. Valderrama

Hospital Universitario Virgen del Rocío, Seville, Spain

A
Alejo Rodriguez-Vida

Hospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain

H
Hilary Glen

Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

F
Fiona Thistlethwaite

The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom

C
Christy Ralph

St. James's Institute of Oncology, University of Leeds, Leeds, United Kingdom

G
Gopalakrishnan Srinivasan

Mid Essex Hospital Services NHS Trust, Broomfield, United Kingdom

M
Maria Jose Mendez-Vidal

Reina Sofía University Hospital, Cordoba, Spain

R
Ryan Hartmaier

Translational Medicine, Oncology R&D, AstraZeneca, Gaithersburg, MD

A
Aleksandra Markovets

Translational Medicine, Oncology R&D, AstraZeneca, Gaithersburg, MD

A
Aaron Prendergast

Barts ECMC, Barts Cancer Institute, Queen Mary University London, London, United Kingdom

B
Bernadett Szabados

Barts ECMC, Barts Cancer Institute, Queen Mary University London, London, United Kingdom

K
Kelly Mousa

Barts ECMC, Barts Cancer Institute, Queen Mary University London, London, United Kingdom

T
Thomas Powles

Barts ECMC, Barts Cancer Institute, Queen Mary University London, London, United Kingdom

Cite This Article
Cristina Suarez, James M.G. Larkin, Poulam Patel, et al. (2023). Phase II Study Investigating the Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer (CALYPSO). Journal of Clinical Oncology, 41(14), 2493-2502. https://doi.org/10.1200/jco.22.01414
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