30: Treatment-free survival (TFS) in patients with advanced renal cell carcinoma (aRCC) treated with nivolumab and ipilimumab (NIVO/IPI) versus sunitinib (SUN): 60-month update of Checkmate 214
Medical Doctor Dana-Farber Cancer Institute Boston, MA, United States
Background: Treatment with immunotherapy can be associated with prolonged disease control after discontinuation without the need for further anticancer therapy. Treatment-related adverse events (TRAEs) can also persist after therapy cessation. TFS with and without toxicity can characterize survival time.
Methods: Data from 1096 patients with aRCC treated with first-line NIVO/IPI (n=550) vs. SUN (n=546) in the CheckMate 214 trial were analyzed. TFS was defined as the area between Kaplan-Meier curves for time from randomization to protocol therapy cessation and time from randomization to subsequent therapy initiation or death.
Results: At 60 months from randomization, 63% and 55% of favorable-risk patients and 43% and 31% of intermediate/poor-risk patients treated with NIVO/IPI and SUN were alive. For favorable-risk patients, the 60-month mean TFS was 14.4 vs. 5.5 months after NIVO/IPI vs. SUN, of which TFS with grade 2+ TRAEs was 5.0 vs. 2.1 months and grade 3+ TRAEs was 1.2 vs. 0.3 months with NIVO/IPI vs. SUN. For intermediate/poor-risk patients, the 60-month mean TFS was 10.1 vs. 4.1 months for NIVO/IPI vs. SUN, of which TFS with grade 2+ TRAEs was 4.0 vs. 2.0 months and grade 3+ TRAEs was 0.6 vs. 0.3 months with NIVO/IPI vs. SUN. At 60 months, 16% and 7% of favorable-risk patients and 18% and 4% of intermediate/poor-risk patients were surviving treatment-free after NIVO/IPI vs. SUN. Subgroup analyses are ongoing.
Conclusions: While overall survival was similar for favorable-risk patients in both treatment groups, patients treated with NIVO/IPI spent more time surviving treatment-free without toxicity compared to SUN after 60 months of follow up. Intermediate/poor-risk patients treated with NIVO/IPI had longer survival and longer TFS without toxicity compared to SUN.