ASCO GU 2019: The Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer, CALYPSO Study
In this session, Dr. Suarez presented the CALYPSO trial, a multi-arm study that includes various histologies (clear cell, papillary and sarcomatoid variant). In summary, the trial enrolled 42 patients with metastatic pRCC who were VEGF treatment naïve or refractory. Patients were treated with savolitinib 600mg and durvalumab 1500mg Q4 weeks. Endpoints included objective response, progression free survival, overall survival, duration of response, best response, and safety. Median follow up on trial was 6.9 months.
63% of patients were IMDC intermediate risk, with 85% receiving prior nephrectomy. 68% of patients had no previous anti-tumor treatment. Median overall survival was not reached (95% CI 7.5 months-NR), suggesting this data is still immature. The overall response rate was 27%, while median progression free survival was 3.3 months. Response rate and median progression free survival in the previously untreated cohort were 29% and 12 months (95% CI 1.5 months-NR) respectively. The most common adverse effects were nausea, edema, fatigue, vomiting, and transaminitis. No correlation between PD-L1 and MET biomarker expression and outcome were noted in this study.
In summary, Dr. Suarez stated that combination savolitinib and durvalumab are associated with a durable response in patients with advanced pRCC. Tolerable adverse event profile was noted for this combination. However, data is still immature and we look forward to longer term follow up and other studies evaluating combinations in advanced papillary RCC.
Presented by: Christina Suarez, MD, PhD, Vall D’Hebron Institute of Oncology, Barcelona, Spain
Written by: David B. Cahn, DO, MBS, @dbcahn, Fox Chase Cancer Center at the Annual ASCO GU meeting 2019, San Francisco, CA, Twitter: @shekabhishek at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA