Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer.

Authors

Cristina Suárez, Sr

Cristina Suarez Rodriguez

Vall d’Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain

Cristina Suarez Rodriguez , James M. G. Larkin , Poulam Patel , Begona Pérez Valderrama , Alejo Rodriguez-Vida , Hilary Glen , Fiona Thistlethwaite , Christy Ralph , Gopalakrishnan Srinivasan , Maria Jose José Mendez Vidal , Abigail Carter , Charlotte Tyson , Aaron Prendergast , Kelly Mousa , Thomas Powles

Organizations

Vall d’Hebron Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona, Spain, Royal Marsden NHS Foundation Trust, London, United Kingdom, Nottingham University Hospital NHS Trust, Nottingham, United Kingdom, Department of Medical Oncology, Hospital Universitario Virgen del Rocío, Seville, Spain, Hospital del Mar, Barcelona, Spain, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom, The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom, St. James's Institute of Oncology, University of Leeds, Leeds, United Kingdom, Mid Essex Hospital Services NHS Trust, Broomfield, United Kingdom, Hospital Universitario Reina Sofia, Cordoba, Spain, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom, International Collaborative Cancer Group (ICCG)/Imperial Clinical Trials Unit-Section of Cancer, Imperial College London, London, United Kingdom

Research Funding

Pharmaceutical/Biotech Company
AstraZeneca.

Background: There is a strong rationale for investigating MET and PD-L1 inhibition in metastatic papillary renal cancer (PRC). We previously reported response rates (RR) and progression free survival (PFS) for savolitinib (MET inhibitor) and durvalumab (PD-L1 inhibitor) together. Here we report overall survival (OS) data available 12 months after the last patient was enrolled. Methods: This single arm phase I/II trial explores durvalumab (1500mg Q4W) and savolitinib (600mg OD) together in PRC, with a 4wk savolitinib run in. Treatment naïve or previously treated patients with metastatic PRC were included. Confirmed RR (RECIST v1.1), PFS, tolerability (CTCAE v4.03) and overall survival (OS) were analysed. MET and PD-L1 biomarkers were explored (NCT02819596). Results: 42 patients were enrolled with 41 receiving at least one dose of study treatment. Safety and efficacy analyses were performed on these 41 patients. The median follow up was 14.3 months. IMDC good, intermediate and poor risk disease occurred in 29%, 63%, and 7% of patients respectively. Overall confirmed RR was 27% while median PFS was 4.9 months (95% CI: 2.5 – 12.0 months). Median OS was 12.3 months (95% CI: 5.8 – 21.3 months). Confirmed RR and median OS in the previously untreated cohort (N=27) were 33% and 12.3 months (95% CI: 4.7 – not reached (NR) months) respectively. Treatment related Grade 3/4 toxicity occurred in 34% of patients. No new safety signals were seen. PD-L1 and MET expression were not associated with higher RR (25% and 40% respectively) or longer OS. Conclusions: The combination of savolitinib and durvalumab has clinical activity in PRC and outcomes were not enhanced in biomarker positive cancers. Clinical trial information: NCT02819596

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02819596

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 619)

Abstract #

619

Poster Bd #

D5

Abstract Disclosures

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