AVEO Oncology and EUSA Pharma Announce TiNivo Combination Study Opt-in

AVEO Oncology and EUSA Pharma announced that EUSA Pharma, under its multi-territory licensing agreement with AVEO for FOTIVDA (tivozanib), has opted into the Phase 1/2 TiNivo study. Under terms of the agreement, 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 1/2 trial of tivozanib in combination with Bristol-Myers Squibb’s 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, MD, Chairman of the Genitourinary Oncology Committee. In June, AVEO announced the advancement of the trial into the Phase 2 expansion portion following successful completion of the Phase 1 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 1 results from the ongoing study have been submitted for presentation at a scientific meeting taking place in the fourth quarter.

“We look forward to working with EUSA in helping shape the future direction of FOTIVDA in an evolving treatment landscape for advanced RCC,” said Michael Bailey, president and chief executive officer of AVEO. “Immunotherapy is defining an important role as an early treatment option for this disease, creating an opportunity to investigate the role of TKIs following immunotherapy or in combination with immunotherapy. Having already demonstrated superior PFS and an improved side effect profile compared to sorafenib in the pivotal TIVO-1 study, FOTIVDA is currently being evaluated in an ongoing third line pivotal trial stratifying for prior immunotherapy, and is well positioned to play a role in this evolving treatment landscape.”

Lee Morley, EUSA Pharma’s Chief Executive Officer said, “Following the recent European approval of FOTIVDA for the first-line treatment of patients with advanced RCC, emerging data from the TiNivo study indicates the potential for FOTIVDA in this setting. With our partner AVEO and the RCC community, we are committed to the ongoing development of FOTIVDA and look forward to investigating new and innovative treatment options for patients with advanced RCC.”

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $388 million in future milestone payments and research and development funding, assuming successful achievement of specified development, regulatory and commercialization objectives. In addition, a tiered royalty will be due to AVEO ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. With European approval, AVEO will be eligible for up to $12 million in milestones from EUSA based on reimbursement and regulatory approvals. In the territories licensed to EUSA, thirty percent of milestone and royalty payments received by AVEO, excluding research and development payments such as the one announced today, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee. In the territories retained by AVEO, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.