AVEO Pharmaceuticals and EUSA Pharma said the Phase 2 portion of a study evaluating a treatment for renal cell carcinoma, the most common type of kidney cancer, showed a total of 72% of patients reported around a quarter shrinkage in their tumors and that a majority of patients kept their disease under control for up to 48 weeks.
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 in combination with nivolumab developed by Bristol-Myers Squibb (NYSE:BMY). The combination was generally well tolerated, the company said. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension.
“With high and durable tumor shrinkage rates for the combination of tivozanib and nivolumab, including a complete response, coupled with a favorable tolerability profile and nearly all patients having disease control, the (TiNivo) study continues to underscore a compelling rationale … in immuno-oncology combinations,” Doctor Bernard Escudier, the ex-chairman of the Genitourinary Oncology Committee, Gustave Roussy, and lead investigator of the study, said.
He added that the ability to give an inhibitor and immuno-oncology agent “at full dose and strength could serve to deliver both improved outcomes and an improved patient experience.”
“We continue to build out a clinical strategy for studying such combinations, and look forward to outlining our plans following reporting of topline data … which is expected in the mid-fourth quarter,” said Michael Bailey, president and CEO of AVEO.
Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.