Related Experiment Video
Updated: Jul 27, 2025
A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Clinical Outcomes of Tivozanib Monotherapy as First-Line Treatment for Metastatic Renal Cell Carcinoma: A
Jonathan Heseltine1,2, Jennifer Allison3, Sam Wong4
1The Clatterbridge Cancer Centre, Clatterbridge Road, Bebington, Liverpool, CH63 4JY, UK. J.heseltine@nhs.net.
Background:
Tivozanib is a licensed as first-line treatment for metastatic renal cell carcinoma (mRCC).
Objective:
To evaluate the outcomes from tivozanib in a real-world mRCC population.
Patients And Methods:
Patients with mRCC commencing first-line tivozanib between March 2017 and May 2019 were identified across four specialist cancer centres in the UK. Data relating to response, overall survival (OS), progression-free survival (PFS) and adverse events (AEs) were collected retrospectively with censoring on 31 December 2020.
Results:
A total of 113 patients were identified: median age was 69 years; 78% had ECOG PS 0-1; 82% had clear cell histology; 66% had previous nephrectomy; International Metastatic RCC Database Consortium (IMDC) score was 22% favourable (F), 52% intermediate (I) and 26% poor (P). Twenty-six per cent were switched from another tyrosine kinase inhibitor (TKI) to tivozanib due to toxicity. Median follow-up was 26.6 months with 18% remaining on treatment at data censoring. Median PFS was 8.75 months. Median PFS by IMDC risk group was: F = 23.0 months; I = 10.0 months; P = 3.0 months, p value < 0.0001. Median OS was 25.0 months (F = not reached (NR) with 72% alive at data cut-off; I = 26.0 months; P = 7.0 months, p value < 0.0001). Seventy-seven per cent had an AE of any grade, and 13% had a grade ≥ 3 AE. Eighteen per cent of patients discontinued treatment due to toxicity. No patients who discontinued a prior TKI due to AEs stopped tivozanib due to AEs.
Conclusions:
These data suggest comparable activity of tivozanib with the pivotal trial data and other TKIs in a real-world population. Its tolerability positions tivozanib as an attractive first-line option for those unsuitable for combination therapies or unable to tolerate other TKIs.
Insights
Tivozanib demonstrates comparable efficacy to pivotal trials in real-world metastatic renal cell carcinoma (mRCC) patients. It offers good tolerability, making it a viable first-line option when other treatments are not suitable.
Area of Science:
- Oncology
- Pharmacology
Background:
- Tivozanib is approved for first-line treatment of metastatic renal cell carcinoma (mRCC).
- Real-world data is crucial for understanding treatment outcomes in diverse patient populations.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of first-line tivozanib in mRCC patients.
- To compare outcomes with existing clinical trial data and other tyrosine kinase inhibitors (TKIs).
Main Methods:
- Retrospective analysis of 113 mRCC patients initiating first-line tivozanib (March 2017-May 2019) across four UK centers.
- Data collected on response, overall survival (OS), progression-free survival (PFS), and adverse events (AEs) with censoring on December 31, 2020.
Main Results:
- Median PFS was 8.75 months, significantly varying by IMDC risk group (Favorable: 23.0, Intermediate: 10.0, Poor: 3.0 months).
- Median OS was 25.0 months (Favorable: NR, Intermediate: 26.0, Poor: 7.0 months).
- 77% experienced any AE, 13% had Grade ≥3 AEs; 18% discontinued due to toxicity. Patients switching from other TKIs due to toxicity did not stop tivozanib for AEs.
Conclusions:
- Tivozanib shows comparable activity to pivotal trials and other TKIs in a real-world mRCC setting.
- Its favorable tolerability profile makes it an attractive first-line choice for patients unable to tolerate other TKIs or combination therapies.
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