AVEO: Checkpoint Inhibitor Fails to Boost Renal Cancer Drug Survival

AVEO Oncology announced that pairing its renal cell carcinoma (RCC) therapy with the PD-1 inhibitor Opdivo (nivolumab) did not offer additional benefits over using Fotivda (tivozanib) alone. Fotivda, an oral VEGFR tyrosine kinase inhibitor (TKI), gained FDA approval in 2021 for treating adults with relapsed or refractory advanced RCC after undergoing at least two prior systemic therapies.

The Phase III TiNivo-2 study evaluated the efficacy of a combination therapy using low-dose Fotivda and Opdivo in patients whose tumors had progressed following immune checkpoint inhibitor (ICI) therapy. The control group received Fotivda alone. The study aimed to determine if the combination therapy would improve progression-free survival compared to Fotivda monotherapy. However, the results indicated that the drug combination did not meet this primary endpoint.

Despite the overall outcome, AVEO highlighted an important observation from the trial. The TiNivo-2 study is the second Phase III clinical trial to indicate that rechallenging RCC patients with immunotherapy after they have shown progression on previous ICIs does not confer additional clinical benefits. The company emphasized that the findings from the monotherapy arm of the study further validate the approved use of Fotivda.

CEO Michael Bailey remarked that the control arm data represents a significant, evidence-based, and clinically meaningful contribution to the oncology community, particularly for those treating relapsed or refractory advanced RCC after initial ICI therapy combinations.

In another significant development, AVEO was acquired by LG Chem in 2022 for approximately $566 million.