AVEO Oncology, an LG Chem Company, Announces Phase 3 Renal Cell Carcinoma Trial Results

AVEO Oncology, an LG Chem company, announced that their TiNivo-2 Phase 3 clinical trial, aimed at advanced metastatic renal cell carcinoma (RCC) patients, did not meet its primary objective of increasing progression-free survival (PFS) by adding nivolumab to a low dose of FOTIVDA® (tivozanib). However, the control group using a standard dose of FOTIVDA demonstrated significant clinical efficacy in the second-line treatment following prior immune checkpoint inhibitor (ICI) therapy, reinforcing FOTIVDA's role as a reliable treatment option in relapsed or refractory advanced RCC after multiple systemic therapies.

The TiNivo-2 trial results align with other recent RCC Phase 3 trials, evidencing no added clinical advantage from rechallenging patients with immunotherapy after progression on previous ICIs. This finding corroborates the outcomes from AVEO's earlier TIVO-3 clinical trial and further supports FOTIVDA's approval and use as an effective and well-tolerated treatment for advanced RCC following multiple prior therapies.

"The progression-free survival and safety data from the FOTIVDA control arm in the second-line setting after ICI combinations add to the substantial evidence supporting highly selective anti-VEGFR tyrosine kinase inhibitor (TKI) therapy as a viable and well-tolerated treatment option for relapsed RCC patients," said Michael P. Bailey, CEO and President of AVEO Oncology. "While combining an ICI with low dose FOTIVDA didn't improve PFS after prior ICI, the control arm data provide valuable, evidence-based insights for the oncology community."

Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and lead investigator, highlighted the significance of the control arm results. He stated that these findings affirm tivozanib's efficacy and tolerability as a second-line treatment for RCC patients previously treated with ICI combinations.

The TiNivo-2 trial was designed to assess the benefits of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose FOTIVDA versus the standard dose FOTIVDA in patients with RCC who had progressed after prior ICI treatment. Enrolled patients from North America, Latin America, and Europe were randomized to receive either tivozanib alone or in combination with nivolumab. The trial's primary endpoint was progression-free survival, with secondary endpoints including overall survival, overall response rate, duration of response, and safety.

These findings will be detailed in an upcoming scientific meeting.

FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) developed to enhance efficacy and tolerability. It selectively inhibits VEGFRs 1, 2, and 3, and was approved by the U.S. FDA on March 10, 2021, for adult patients with relapsed or refractory advanced RCC after two or more prior systemic therapies, based on TIVO-3 trial data comparing FOTIVDA to sorafenib. It was also approved in the European Union and other territories in August 2017 for treating advanced RCC in adults.

The safety profile of FOTIVDA includes common adverse reactions such as hypertension, diarrhea, and fatigue, among others. Severe risks include cardiac failure, thromboembolic events, and hemorrhagic events, necessitating close monitoring and management of patients undergoing treatment.

AVEO Oncology continues to develop and market FOTIVDA in the U.S. for advanced RCC and explores its potential in other immuno-oncology and targeted therapy combinations. As a wholly-owned subsidiary of LG Chem Life Sciences USA, AVEO remains committed to advancing oncology treatments.