Comparison of clinical outcomes of cabozantinib plus nivolumab and lenvatinib plus pembrolizumab in patients with metastatic renal cell carcinoma.

PURPOSE: This study aimed to evaluate the treatment outcomes and safety of cabozantinib plus nivolumab (C + N) and lenvatinib plus pembrolizumab (L + P) for patients with metastatic renal cell carcinoma (mRCC).

METHODS

This multicenter retrospective analysis included 92 patients with mRCC treated with either C + N or L + P as first-line therapy between April 2018 and August 2024. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs) were compared. Multivariable analysis was performed to identify independent prognostic factors for PFS.

RESULTS

Fifty-three patients received C + N and 39 received L + P. PFS (24.1 months vs. not reached, P = 0.725) and OS (46.7 months vs. not reached, P = 0.912) were not significantly different between the C + N and L + P groups. Over a median follow-up duration of 13.9 months, 31 patients experienced disease progression and 12 died. ORR was higher in the C + N group than in the L + P group (79% vs. 49%, P = 0.002), whereas DCR (100% vs. 95%, P = 0.096) and grade ≥ 3 TRAEs (47% vs. 36%, P = 0.280) were comparable. In the multivariable analysis, the treatment regimen (C + N as a reference) was not significantly associated with PFS (hazard ratio: 0.76, P = 0.476). Favorable/intermediate International mRCC Database Consortium risk was identified as an independent prognostic factor for PFS.

CONCLUSION

Treatment with C + N and L + P resulted in comparable PFS, OS, and safety profiles in patients with mRCC. Both regimens can be used to treat mRCC based on individual characteristics.