53: Outcomes of patients with metastatic renal cell carcinoma (mRCC) treated with tivozanib (TIVO) in the contemporary treatment landscape: The MD Anderson Cancer Center (MDACC) experience
Clinical Fellow, Hematology and Medical Oncology MD Anderson Cancer Center, TX, United States
Background: TIVO was approved for treatment of advanced RCC in ≥3rd line based on improved progression-free survival (PFS) compared with sorafenib. However, the sequencing of therapies for RCC has evolved since TIVO’s approval, and the clinical benefit of TIVO in the contemporary therapeutic landscape has not been appraised in a real-world experience.
Methods: We performed a retrospective study of patients with mRCC (any histology) treated with TIVO at MDACC during 6/2021-7/2023. Demographic and clinical data were abstracted from the electronic medical records. A blinded radiologist assessed tumor response by RECIST v1.1. Objective response rate (ORR), time on treatment (TOT), progression-free survival (PFS), safety, and overall survival (OS) were assessed.
Results: 34 patients were included in the analysis. Median follow-up was 10.1 months, 88% of patients had ≥3 metastatic sites and 47% had IMDC poor-risk disease at TIVO start. Median number of prior therapies was 4 (range 1-8). All patients received prior checkpoint inhibitors (35% nivolumab/ipilimumab), 88% received prior cabozantinib and 65% lenvatinib +/- everolimus. Of 29 patients with evaluable radiologic response, 1 patient had confirmed partial response (ORR 3.4%) and 6 patients had stable disease for ≥6 months (clinical benefit rate 24.1%). Median TOT was 2.9 months (range 0.1-13.5), median PFS 3.8 months (95% CI: 2.2, 4.7; range 0.7-13.5), and median OS not reached (12 deaths at time of analysis). Twenty patients discontinued TIVO due to progressive disease, 4 (11.8%) for toxicity (3 patients w/ grade ≥3 hypertension), and 2 for other reasons (declining PS, infection). One patient died of treatment-related GI perforation.
Conclusions: In this contemporary cohort of heavily pretreated patients with mRCC, TIVO produced a modest clinical benefit in a minority of patients.