Comparison of effectiveness and safety of pembrolizumab plus lenvatinib versus nivolumab plus cabozantinib for metastatic renal cell carcinoma: a real-world study.

BACKGROUND

Pembrolizumab plus lenvatinib (Pem-Len) and nivolumab plus cabozantinib (Nivo-Cabo) are effective first-line regimens for metastatic renal cell carcinoma (RCC); however, real-world data directly comparing these regimens are limited. We conducted a retrospective analysis to compare their clinical outcomes in Japanese patients.

METHODS

Patients with metastatic RCC who received Pem-Len or Nivo-Cabo as first-line systemic therapy at Kobe University Hospital and affiliated institutions between August 2018 and September 2025 were included. Clinicopathological characteristics and treatment outcomes were compared between the two groups.

RESULTS

A total of 139 patients received Pem-Len and 97 received Nivo-Cabo. Patients in the Nivo-Cabo group were significantly older than those in the Pem-Len group. After propensity score matching for prognostic factors, progression-free survival (PFS) was significantly longer in the Pem-Len group than in the Nivo-Cabo group (not reached vs. 15.9 months, P = 0.019), but there was no significant difference in overall survival between the groups (not reached vs. 31.5 months, P = 0.308). The incidence of grade ≥ 3 adverse events was comparable between the groups (51.8% vs. 55.4%, P = 0.756).

CONCLUSION

In this real-world analysis, Pem-Len was associated with longer PFS than Nivo-Cabo in patients with metastatic RCC, with comparable safety profiles.