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Abstract Purpose: A clinically meaningful attribute of some immune-oncology (IO) regimens is potential durable clinical benefit during a treatment-free interval. We characterize treatment-free survival (TFS) with and without ongoing toxicity in trials of frontline IO-VEGF tyrosine kinase inhibitor (TKI) combinations in patients with advanced renal cell carcinoma (aRCC). Experimental Design: Individual patient data were pooled by treatment arm from randomized trials submitted to the FDA evaluating IO-TKI combination in treatment-naïve aRCC with at least 30 months of median follow-up. OS, TFS, TFS with and without toxicity, and time to all protocol therapy cessation were assessed. TFS was estimated by 30-month restricted mean times, defined as area between Kaplan–Meier curves for two time-to-event endpoints originating at randomization: time to all protocol therapy cessation and time to subsequent systemic therapy initiation or death. Results: Three trials met criteria for analysis; 1, 183 patients received IO-TKI versus 1, 184 on control arms receiving TKI alone (sunitinib, SUN). IO-TKI and SUN groups spent 9% 2. 7 months 95% confidence interval (CI), 1. 8–3. 5 and 10% 2. 9 months (95% CI, 2. 1–3. 8) of the 30-month period alive and treatment-free, respectively. Mean TFS without grade ≥3 toxicity was 1. 7 and 2. 3 months in IO-TKI and SUN groups, respectively. Conclusions: In this post hoc partitioned survival analysis, TFS and TFS without toxicity appeared similar in the IO-TKI group compared with the SUN group. These findings may reflect contin-uation of TKI until progression per protocol design in all trials and discontinuation of IO after 2 years in two trials. See related commentary by Stadler and Karrison, p. 3098
Chang et al. (Wed,) studied this question.
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