Tivozanib drug shows superior PFS over sorafenib in Phase 3 study

16th May 2012 (Last Updated May 16th, 2012 18:30)

Aveo Oncology and Astellas Pharma have announced positive findings from the Tivozanib Versus Sorafenib in 1st line Advanced RCC (TIVO-1) study of its investigational agent tivozanib.

RCC

Aveo Oncology and Astellas Pharma have announced positive findings from the Tivozanib Versus Sorafenib in 1st line Advanced RCC (TIVO-1) study of its investigational agent tivozanib.

Tivozanib is an oral, once-daily long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, designed to optimise VEGF blockade while reducing off-target toxicities.

TIVO-1 is a global randomised Phase 3 superiority clinical trial conducted in 517 patients with advanced renal cell carcinoma (RCC) to investigate the efficacy and safety of tivozanib compared to sorafenib.

In the overall study population, tivozanib demonstrated improvement in progression-free survival (PFS) with a median PFS of 11.9 months, compared to a median PFS of 9.1 months for sorafenib, based on independent radiological reviews.

Patients who were treatment naïve for advanced RCC reported improvement in PFS with a median PFS of 12.7 months with tivozanib, compared to a median PFS of 9.1 months for sorafenib.

"In the overall study population, tivozanib demonstrated improvement in progression-free survival."

Cornell University, US, Weill Medical College medicine professor and Memorial Sloan-Kettering Cancer Center genitourinary oncology service attending physician Robert Motzer said TIVO-1 is novel in that the Phase 3 clinical study used an approved targeted comparator drug to evaluate first-line RCC treatment.

"Patients in the study who had no prior treatment for advanced kidney cancer and who were given tivozanib met the primary PFS endpoint and tolerated the drug well," Motzer added.

Astellas Pharma Global Development president Steven Ryder said based on the data, the company looks forward to advancing tivozanib in kidney cancer with Aveo.

"These data further support Astellas' goal of leadership in oncology and our commitment to developing a world-class oncology platform based on innovative, research-driven solutions and dynamic partnerships," Ryder added.

The data also showed that the objective response rate (ORR) for tivozanib was 33% versus 23% for sorafenib, demonstrating a consistent efficacy across subgroups in the Phase 3 study.


Image: Micrograph of the most common type of renal cell carcinoma on right of the image and non-tumour kidney is on the left of the image. Photo courtesy of: Nephron.