Tivozanib Effective in Advanced Renal Cell Carcinoma After ICI Therapy

On Friday, September 20, 2024, a new study published in The Lancet provides critical insights into the efficacy of tivozanib for patients with metastatic renal cell carcinoma (mRCC) who have experienced disease progression after one or two prior treatments, including one immune checkpoint inhibitor (ICI). The findings were released to coincide with the annual meeting of the European Society for Medical Oncology, held from September 13 to 17 in Barcelona, Spain.

The research, led by Dr. Toni K. Choueiri from the Dana-Farber Cancer Institute and Harvard Medical School, focused on comparing the outcomes of tivozanib combined with nivolumab versus tivozanib alone. This randomized, phase 3 trial involved patients with mRCC who had progressed after one or two lines of therapy in a post-ICI setting. A total of 343 patients participated in the study, with 171 receiving the combination treatment of tivozanib and nivolumab, and 172 receiving tivozanib alone. The participants were monitored for a median period of 12 months.

The study revealed that the median progression-free survival for patients treated with tivozanib and nivolumab was 5.7 months, compared to 7.4 months for those treated with tivozanib alone, a difference that was not statistically significant. In a subset of 244 patients who had recently undergone ICI therapy, the median progression-free survival was 7.4 months for the combination treatment and 9.2 months for tivozanib monotherapy. For patients whose most recent treatment was not an ICI, the median progression-free survival was 3.7 months for both treatment groups, indicating no significant difference.

The incidence of serious adverse events was comparable between the two groups, occurring in 32 percent of patients receiving the combination therapy and 37 percent of those on tivozanib monotherapy.

The authors concluded that tivozanib monotherapy demonstrated clinical activity as a second-line treatment option for mRCC. They also noted that rechallenging with nivolumab after prior ICI exposure does not appear to be beneficial.

Additionally, several authors of the study disclosed financial connections to pharmaceutical companies, including Aveo Pharmaceuticals, which manufactures tivozanib and funded the research.