219P - Clinical effectiveness of tislelizumab plus TKI as first-line therapy in patients with metastatic renal cell carcinoma (mRCC): A real-world study

Background

Tyrosine kinase inhibitor (TKI) combined with immune checkpoint inhibitor（ICI）had demonstrated efficacy as first-line therapy for mRCC patients（pts）in clinical trials. However, data on real-world outcomes were limited. Our study aimed to evaluate the effectiveness of tislelizumab plus TKI in pts with mRCC.

Methods

Demographic and clinicopathological data of pts with mRCC between July 2019 and November 2022 were retrospectively collected from Sun Yat-sen University Cancer Center. All pts received first-line treatment with TKI monotherapy (TKI group, mainly sunitinib) or tislelizumab plus TKI therapy (combination group，mainly plus axitinib). TKI group who failed first-line therapy received tislelizumab plus TKI as second-line regimen. Combination group who failed first-line therapy received TKI or ICI plus TKI as second-line regimen. Outcomes including the objective response rate (ORR), progression-free survival (PFS), PFS2 (defined as time from initial treatment to progression after first subsequent therapy or any-cause death.) and overall survival (OS) were calculated.

Results

Totally 136 pts were analyzed, with a median age of 57 (17-81) years. 72.1% were male, 71.3% had clear cell RCC, 78.8% had an IMDC intermediate/poor-risk disease, 62.5% had metastatic number≥2, metastatic organs included lung (47.1%), bone (27.9%), liver (13.2%) and brain (5.1%). The median follow-up was 26.4 (23.1-29.6) months. The combination group (n=61) had a significantly longer PFS compared with the TKI group (n=75) (median PFS (95% CI): 17.4 (13.9-20.9) vs 6.2 (5.5-6.9) months, P<0.001). Similarly, the PFS2 was longer in the combination group (median PFS2 (95% CI): 23.5 (7.7-39.3) vs 14.7 (11.1-18.3) months, P=0.011). Besides, ORR was remarkably improved in the combination group (44.3% vs 18.7%, P=0.001). Median OS was not reached for combination group and 42.9 months for TKI group (p = 0.081).

Conclusions

Our data demonstrated effectiveness of tislelizumab plus TKI as first-line treatment for mRCC pts in real world.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Sun Yat-sen University Cancer Center.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.