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Tivozanib: status of development

Muhammad Omer Jamil1, Amanda Hathaway, Amitkumar Mehta

  • 1Division of Hematology and Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, 1720 2nd Avenue South, NP2540N, Birmingham, AL, 35294, USA.

Current Oncology Reports
|April 22, 2015
PubMed

Insights

Tivozanib, a VEGF receptor inhibitor, showed promise in preclinical studies but faced setbacks in metastatic clear cell renal cell carcinoma clinical trials. Ongoing research explores its potential in other cancers and as a biomarker for treatment response.

Area of Science:

  • Oncology
  • Pharmacology
  • Molecular Biology

Background:

  • Tivozanib is an oral tyrosine kinase inhibitor targeting vascular endothelial growth factor (VEGF) receptors.
  • It demonstrated preclinical efficacy in various solid tumors.
  • Previous clinical trials in renal cell carcinoma yielded mixed results regarding overall survival.

Purpose of the Study:

  • To evaluate the efficacy and safety of tivozanib in diverse solid tumors.
  • To investigate the role of neuropilin-1 (NRP-1) as a predictive biomarker for tivozanib response.
  • To explore ongoing clinical trials assessing tivozanib in hepatocellular carcinoma, sarcomas, and gynecologic cancers.

Main Methods:

  • Phase III TIVO-1 trial comparing tivozanib with sorafenib in metastatic clear cell renal cell carcinoma.
  • Analysis of serum neuropilin-1 (NRP-1) levels in the BATON-CRC trial.
  • Ongoing clinical trials in various solid tumor types.

Main Results:

  • Tivozanib demonstrated potent inhibition of VEGF receptors.
  • The TIVO-1 trial did not meet its primary endpoint for overall survival in renal cell carcinoma, leading to a negative recommendation from ODAC.
  • Low serum NRP-1 levels correlated with improved progression-free survival in patients treated with tivozanib in the BATON-CRC trial.

Conclusions:

  • Tivozanib's efficacy in renal cell carcinoma requires further investigation, despite its potent VEGFR inhibition.
  • Neuropilin-1 (NRP-1) shows potential as a predictive biomarker for tivozanib treatment response.
  • Further clinical trials are warranted to fully characterize tivozanib's activity in other solid tumors, including hepatocellular carcinoma, sarcomas, and gynecologic cancers.

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