MONDAY, Sept. 26, 2022 (HealthDay News) -- Triplet therapy of cabozantinib + nivolumab + ipilimumab significantly improves progression-free survival (PFS) compared with placebo + nivolumab + ipilimumab for patients with previously untreated advanced renal cell carcinoma (aRCC) of intermediate or poor risk, according to a study presented at the annual meeting of the European Society for Medical Oncology, held from Sept. 9 to 13 in Paris.
Toni Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a randomized phase 3 study involving previously untreated patients with clear cell aRCC of International Metastatic RCC Database Consortium intermediate or poor risk. A total of 855 patients were randomly assigned to receive cabozantinib or matched placebo; both treatment groups also received nivolumab and ipilimumab for four cycles, followed by nivolumab for up to two years.
The researchers found that the study met the primary PFS end point (hazard ratio, 0.73); median PFS was not reached for the triplet therapy and was 11.3 months for placebo + nivolumab + ipilimumab. The objective response rate was 43 and 36 percent for the triplet therapy and placebo + nivolumab + ipilimumab groups, respectively; the median duration of response was not reached in either group. Grade 3/4 treatment-related adverse events occurred in 73 and 41 percent of those receiving triplet therapy and placebo + nivolumab + ipilimumab, respectively.
"The initial findings provide a clear look at the efficacy and safety profile of this triplet therapy and demonstrate a significant progression-free survival benefit," Choueiri said in a statement.
Several authors disclosed financial ties to biopharmaceutical companies, including Exelixis, which manufactures cabozantinib and funded the study.