14 February 2018 - - Cambridge, Massachusetts-based cancer therapeutics specialist Aveo Oncology (NASDAQ: AVEO) and Hemel Hempstead, England-based specialty pharmaceutical company EUSA Pharma have presented preliminary results from the Phase 2 portion of the TiNivo trial of oral tivozanib (Fotivda) in combination with intravenous nivolumab (Opdivo, Bristol-Myers Squibb), for the treatment of metastatic renal cell carcinoma, the companies said.
The results were presented at the 2018 American Society of Clinical Oncology's Genitourinary Cancers Symposium (ASCO GU) in a poster presentation titled "Tivozanib combined with nivolumab: Phase Ib/II study in metastatic renal cell carcinoma."
The Phase 1/2 multicenter study has enrolled a total of 27 patients. The Phase 2 portion of the study was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of PO tivozanib (1.5 mg/QD for 21 days followed by a 7-day rest period), as established in the Phase 1 portion of the study, in combination with IV nivolumab (240 mg every 2 weeks).
The combination was generally well tolerated. Treatment-related Grade 3/4 adverse events occurred in 44% of patients, the most common of which was hypertension.
Tivozanib (Fotivda) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor of all three VEGF receptors.
It is designed to optimize VEGF blockade while minimizing off-target toxicities, and has been shown to significantly reduce regulatory T-cell production in preclinical models. Fotivda has been investigated in several tumors types, including renal cell, hepatocellular, colorectal, and breast cancers.
EUSA Pharma focuses on oncology and oncology supportive care. The company has commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world.
Aveo Oncology is dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need.
The company is focused on development and commercialisation of its lead candidate tivozanib as a treatment for renal cell carcinoma and other cancers in North America, and is leveraging multiple partnerships to develop and commercialise tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia.