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Outcomes with durvalumab and savolitinib in metastatic papillary renal cancer (mPRC) according to international metastatic renal cell carcinoma database consortium (IMDC) risk groups

Choy, J.
Rodriguez, C. S.
Larkin, J.
Patel, P.
Valderrama, B. P.
Rodriguez-Vida, A.
Glen, H.
Thistlethwaite, Fiona C
Ralph, C.
Srinivasan, G.
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Abstract
Background: Recent studies have shown the important role of MET and PD-L1 inhibition in mPRC. Response rate (RR), progression free survival (PFS) and overall survival (OS) for Savolitinib and Durvalumab combined have previously been reported in a papillary cohort. Here we present RR, PFS and OS data according to risk classification using IMDC criteria based on interim data available 12 months after the last patient was enrolled. Methods: This arm within a phase I/II trial investigated Durvalumab and Savolitinib in both treatment naïve and previously treated patients with mPRC. Confirmed RR (RECIST v 1.1), PFS (RECIST v 1.1) and OS according to IMDC risk score were then analysed. Kaplan-Meier and univariate Cox regression analysis were performed. Results: Data from 41 patients were evaluated over a median follow-up period of 14.3 months and a comparison between good (N¼12) versus intermediate/poor (N¼29) was made. 2 patients stopped treatment due to toxicity in the good IMDC risk group and 5 in the intermediate/poor risk group. Overall RR was 27%, median PFS was 4.9 months (95% CI: 2.5-12.0) and median OS was 12.3 months (95% CI: 5.8-21.3). RR was 42% and 21% in patients with good and intermediate/poor IMDC classification, respectively. Twelve-month PFS was 53.7% in good IMDC risk disease(95% CI: 15.5- 18.3) and 22.5% in the intermediate/poor risk IMDC cohort (95% CI: 9.2-39.4). Twelvemonth OS was 78.8% in those with good risk disease(95% CI: 38.1-94.3) and 42.0% in the intermediate/poor risk group (95% CI: 23.5-59.5). In regression analysis, the survival results in the good IMDC risk group were superior to those in the intermediate/ poor IMDC group (hazard ratio for death 0.27, 95% CI: 0.08-0.92; p¼0.037; hazard ratio for progression 0.33, 95% CI: 0.11-0.96; p¼0.042). Conclusions: The combination of Savolitinib and Durvalumab is active across IMDC risk groups, this appears more marked in good risk disease.
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2020
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Meetings and Proceedings
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Choy J, Rodriguez CS, Larkin J, Patel P, Valderrama BP, Rodriguez-Vida A, et al. 69P Outcomes with durvalumab and savolitinib in metastatic papillary renal cancer (mPRC) according to international metastatic renal cell carcinoma database consortium (IMDC) risk groups. Annals of Oncology. 2020;31:S1446-S.
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