ASCO GU 2020: Overall Survival Results for Durvalumab and Savolitinib in Metastatic Papillary Renal Cancer

San Francisco, California (UroToday.com) There is a strong rationale for investigating the utility of PD-L1 and MET inhibition in the management of metastatic papillary renal cell carcinoma.  Durvalumab is a humanized monoclonal antibody that inhibits PD-L1.  Savolitinib is a potent selective MET inhibitor that has been shown to have activity in patients with MET driven papillary renal cell carcinoma.1 In the previously reported CALYPSO trial, which evaluated the safety and efficacy of combination durvalumab and savolitinib in patients with metastatic papillary renal cell carcinoma, the objective response rate of durvalumab and savolitinib was 27% with a median progression-free survival of 5.3 months.2

Dr. Christina Suarez Rodriguez presented a single arm phase I/II trial that evaluated the overall survival associated with combination durvalumab and savolitinib in patients with metastatic papillary renal cell carcinoma.  Furthermore, the authors set out to confirm the response rate, progression-free survival, and safety of the treatment regimen demonstrated in the CALYPSO trial.  In the presented study, patients underwent treatment with durvalumab and savolitinib after a 4-week savolitinib run in.  The study enrolled patients with metastatic papillary renal cell carcinoma regardless of whether they were treatment naïve or previously treated. 

The study designed utilized is shown: 

ASCOGU_CALYPSO_trial.png

Of 42 patients enrolled, 41 patients received at least one dose of study treatment.  At a median follow up of 14.3 months, the overall confirmed response rate was 27%, median progression-free survival was 4.9 months (95% CI: 2.5 – 12.0 months), and median overall survival was 12.3 months (95% CI: 5.8 – 21.3 months).  In the previously untreated cohort (n=27), the response rate was 33% and the median overall survival was 12.3 months (95% CI: 4.7 – not reached months).  With regards to treatment related adverse events, grade 3-4 adverse events occurred in 34% of patients.  PD-L1 and MET expression were not associated with higher response rate or longer overall survival. 

Dr. Rodriguez concluded that the combination of durvalumab and savolitinib has clinical activity with encouraging response rates, PFS, and OS in patients with metastatic papillary renal cell carcinoma.  Furthermore, outcomes were not enhanced by biomarker positive cancers. 

Presented by: Cristina Suarez Rodriguez, MD, Associate Professor, University of Washington School of Medicine, Seattle, Washington

Written by: Ziho Lee, MD Fellow in Advanced Robotic Oncology and Reconstruction Temple University, Philadelphia, PA Twitter: @ZLeeGU at the 2020 Genitourinary Cancers Symposium, ASCO GU #GU20, February 13-15, 2020, San Francisco, California

References:

  1. Choueiri TK, Plimack ER, Arkenau H-T, et al. "A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC)" American Society of Clinical Oncology 35, no. 6 (February 2017): 436-436.
  2. Powles T, Larkin JMG, Patel P, et al. A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). San Franscisco: 2019 Genitourinary Cancers Symposium. Abstract 545. Presented February 16, 2019.
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