Real-world outcomes among patients with advanced/metastatic renal cell carcinoma (mRCC) treated with tyrosine kinase inhibitors (TKls) monotherapy or TKI-IO combination therapy.

e16514 Background: Tyrosine kinase inhibitors (TKI) monotherapy or TKI in combination with immunotherapeutic agents (IO) are standard of care fist-line treatment for advanced or metastatic renal cell carcinoma (RCC). TKI monotherapy is extremely frequently in China because of the medicine Indications and health care policy. We examined the outcomes of patient treated with TKI in monotherapy and in combination with immunotherapy (TKI-IO) in Chinese patients. Methods: We performed a retrospective analysis of clinical outcomes in patients with RCC treated with TKI (cohort 1) or TKI-IO (cohort 2) in Sun Yat-sen Cancer Center between Dec 1,2015 and Nov 30,2022. Median follow-up was 26.1m (range from 0 to 87.6). Real-world progression free survival (1L-rwPFS), 2L-rwPFS and PFS2 (1L-rwPFS+2L-rwPFS),which means progression free survival from first-line treatment to second-line progression were calculated by Kaplan-Meier analysis and compared by the log-rank test. Cox proportional-hazard models were used to obtain hazard ratios (HRs) with 95%. Results: In total,325 patients were included. The median age was 55 (16-83), Male 75% (244), Female 25% (81). In cohort 1, 264 patients received 1L TKI and in cohort 2, 61 patients received 1L TKI-IO treatment. Median 1L-rwPFS in cohort1 was 7.7m VS 17.2m in cohort2 (HR 0.43 [0.32; 0.56]; p<0.00001), amongst all patients, the TKI monotherapy most frequently prescribed was sunitinib, for TKI-IO, the most prescribed was axitinib plus Tislelizumab Injection. Median PFS2 was longer in TKI-IO (32.6m vs 24.8m) (HR 0.42 [0.27;0.66], p<0.00001). In cohort 1, 37 patients progression with prior TKI monotherapy received 2L TKI therapy, while 211 patients received TKI-IO, median 2L-rwPFS was longer in 2L TKI-IO (14.2m vs 7.5m) (HR 0.52 [0.33;0.83], p=0.00043), PFS2 also had similar trend 20.3m VS 27m (HR 0.62 [0.40;0.96], p=0.0095). In 211 patients 2L TKI-IO cohort, the most prescribed was axitinib+IO (182/211), median 2L-rwPFS was 15.2m in axitinib+IO VS 8.2m in IO+other TKI (HR 0.41 [0.23;0.72], p<0.00001).Data is contained in the table. Conclusions: Our retrospective cohort study suggests that TKI-IO provides a significant progression-free survival advantage over TKI monotherapy, whether used in the first-line or the subsequent line of therapy. Axitinib may be one of the best companions for immunotherapy. [Table: see text]