107P - Efficacy and safety of first-line TKI plus ICI therapy in metastatic non-clear cell renal cell carcinoma: A real-world multiple-centre study

Background

Metastatic non-clear cell renal cell carcinoma (mnccRCC) currently lacks standard first-line treatment options. This study evaluated the effectiveness and safety of ICI plus tyrosine kinase inhibitor (TKI) in mnccRCC patients through multi-center real-world evidence, encompassing the largest sample size to date.

Methods

We conducted a retrospective analysis of treatment-naive metastatic non-clear cell renal cell carcinoma (mnccRCC) patients who received either TKI monotherapy or TKI + ICI combination therapy at four hospitals in China. Baseline characteristics were recorded, and comparisons were made between the two groups in terms of objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs).

Results

A total of 214 mnccRCC patients were enrolled from the four hospitals: 122 in the TKI monotherapy group and 92 in the TKI + ICI combination group. The median follow-up time was 36.5 months (interquartile range [IQR], 24.2–57.0), with a median age of 49 years and a majority of male patients (70.6%). Compared to the TKI group, the TKI + ICI group showed a significantly higher objective response rate (29.4% vs. 16.4%, P < 0.01) and disease control rate (78.3% vs. 48.4%, P < 0.01). Additionally, the combination therapy group had a longer progression-free survival [median PFS (95% CI): 15.2 (6.6–23.7) months vs. 5.9 (4.3–7.5) months, P < 0.001] and a longer overall survival [median OS (95% CI): not reached vs. 38.5 (26.6–50.4) months, P = 0.019]. The incidence of grade 3 or higher treatment-related adverse events was slightly higher in the combination therapy group, but the difference was not statistically significant (35.8% vs. 23.7%, P = 0.079).

Conclusions

Our retrospective real-world study demonstrates that, compared to TKI monotherapy, the combination of ICI and TKI significantly improves progression-free survival (PFS), objective response rate (ORR), and overall survival (OS) in patients with metastatic non-clear cell renal cell carcinoma (mnccRCC), with manageable safety. This study provides stronger evidence for the pharmacological treatment of metastatic non-clear cell renal cell carcinoma.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.