AVEO Oncology (NASDAQ:AVEO) has announced the final overall survival data from the Phase 3 TIVO-3 Study in the European Urology journal.
AVEO publishes TIVI-3 study results in European Urology Journal
The TIVO-3 study is AVEO’s pivotal third phase study comparing tivozanib to sorafenib in 3rd and 4th line renal cell carcinoma. Tivozanib is the company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGF TKI)treatment. The results were published in the journal under the title “Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma.”
Sumanta Pal, the lead author of the publication, stated that the TIVO-3 study results represent the first superiority trial in the fast-growing patient population that has become refractory or relapsed to multiple therapy lines that include checkpoint inhibitors. Pal said that the TIVO-3 study data shows a favorable efficacy and safety profile compared to sorafenib. This was demonstrated by the superior overall response activity and anti-tumor progression-free survival compared to another VEGFR TKI combined with dose reductions, discontinuations, and interruptions.
Also, the study’s OS hazard ratio was consistent with past Phase 3 studies that compared two VEGF-focussed agents. Sumanta added that they believe tivozanib has the potential of offering patients a meaningful treatment alternative in a setting that currently lacks an evidence-based standard of care.
AVEO working on NDA for tivozanib
AVEO CEO and President Michael Bailey said that for the growing RCC patient population refractory or relapsed multiple therapy lines, the lack of clinical data guiding treatment decisions in the patient population poses challenges for physicians and patients. Bailey said that they expect the TIVO-3 data of tivozanib to potentially guide treatment decisions in the setup and thus enhance patients’ outcomes. He added that the company is looking forward to working with the FDA in the processes of reviewing its NDA submission for the treatment of refractory or relapsed RCC with tivozanib.
