EUSA Pharma opts into combination study

UK-based EUSA Pharma, under its multi-territory licensing agreement with the USA’s AVEO Oncology (Nasdaq: AVEO) for Fotivda (tivozanib), has opted into the Phase I/II TiNivo study, with the news sending AVEO’s shares up nearly 4% to $3.99 in pre-market trading on Wednesday.

Under terms of the accord, EUSA may utilize data from the study for regulatory or commercial purposes in exchange for a research and development funding payment totaling $2.0 million. EUSA’s decision follows approval in August of tivozanib by the European Commission for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.

The TiNivo trial is a Phase I/II study of tivozanib in combination with Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of RCC. The TiNivo trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, chairman of the Genitourinary Oncology Committee. In June, AVEO announced the advancement of the trial into the Phase II expansion portion following successful completion of the Phase I dose escalation portion. The combination was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The expansion portion of the trial is expected to enroll an additional 20 subjects. Phase I results from the ongoing study have been submitted for presentation at a scientific meeting taking place in the fourth quarter.