FRIDAY, Oct. 2, 2020 — Nivolumab combined with cabozantinib is superior to sunitinib alone for the treatment of advanced clear cell renal cell carcinoma, according to a study presented at the annual meeting of the European Society for Medical Oncology, held virtually from Sept. 19 to 21.
Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3 randomized trial evaluating the checkpoint inhibitor nivolumab plus the tyrosine kinase inhibitor cabozantinib (323 patients) versus sunitinib (328 patients) for first-line treatment of advanced clear cell renal cell carcinoma.
During a median follow-up of 18.1 months, the researchers found that all three efficacy end points were met. Compared with sunitinib, nivolumab + cabozantinib significantly improved progression-free survival (hazard ratio, 0.51; median, 16.6 versus 8.3 months) and overall survival (hazard ratio, 0.60). Results were consistent across prespecified International Metastatic RCC Database Consortium risk and programmed death ligand 1 expression subgroups. With nivolumab + cabozantinib, the objective response rate was significantly higher compared with sunitinib (55.7 versus 27.1 percent), and a higher percentage of patients achieved complete response (8.0 versus 4.6 percent). Any-grade treatment-related adverse events occurred in 96.6 percent of patients treated with nivolumab + cabozantinib and 93.1 percent of patients treated with sunitinib (60.6 and 50.9 percent for grade ≥3, respectively).
“These results, along with manageable toxicity and superior health-related quality of life, highlight this regimen’s potential importance among combinations of immunotherapies and tyrosine kinase inhibitors,” Choueiri said in a statement.
The research was funded by Bristol Myers Squibb, Ono Pharmaceutical Co., Exelixis, Ipsen, and Takeda.
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