Tivozanib has efficacy in advanced renal cell carcinoma post-immune checkpoint inhibitor therapy

For patients with metastatic renal cell carcinoma (mRCC) and progression during or after one to two prior lines of therapy, including one immune checkpoint inhibitor (ICI), tivozanib has efficacy, according to a study published online Sept. 13 in The Lancet to coincide with the annual meeting of the European Society for Medical Oncology, held from Sept. 13 to 17 in Barcelona, Spain.

Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute and Harvard Medical School in Boston, and colleagues examined the outcomes of tivozanib-nivolumab versus tivozanib monotherapy in patients with mRCC who progressed following one or two lines of therapy in the post-ICI setting in a randomized, phase 3 trial. Patients were randomly allocated to tivozanib plus nivolumab or tivozanib monotherapy (171 and 172 patients, respectively) and were followed for a median of 12.0 months.

The researchers found that median progression-free survival was 5.7 and 7.4 months with tivozanib-nivolumab and tivozanib monotherapy, respectively, which was not significantly different. Among 244 patients with ICI as immediate prior therapy, median progression-free survival was 7.4 and 9.2 months with tivozanib-nivolumab and tivozanib monotherapy, respectively.

With non-ICI as the most recent therapy, median progression-free survival was lower, with no significant difference seen between the groups (both 3.7 months). Serious adverse events occurred in 32 and 37 percent of patients who received tivozanib-nivolumab and tivozanib monotherapy, respectively.

“These results demonstrated clinical activity of tivozanib monotherapy as a second line treatment option, and rechallenging with nivolumab in the setting of prior exposure to ICI is not warranted,” the authors write.

Several authors disclosed ties to pharmaceutical companies, including Aveo Pharmaceuticals, which manufactures tivozanib and funded the study.

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