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Background <p>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.</p> Methods <p>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.</p> Results <p>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, <i>P</i> = 0.019), but there was no significant difference in overall survival between the groups (not reached vs. 31.5 months, <i>P</i> = 0.308). The incidence of grade ≥ 3 adverse events was comparable between the groups (51.8% vs. 55.4%, <i>P</i> = 0.756).</p> Conclusion <p>In this real-world analysis, Pem-Len was associated with longer PFS than Nivo-Cabo in patients with metastatic RCC, with comparable safety profiles.</p>

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

  • 期刊论文

  • 发表日期：

    2026年5月27日

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  • Taisuke Tobe,
  • Jun Teishima,
  • Yoshie Mita,
  • Hideto Ueki,
  • Yusuke Shiraishi,
  • Naoto Wakita,
  • Yasuyoshi Okamura,
  • Yukari Bando,
  • Kotaro Suzuki,
  • Takuto Hara,
  • Tomoaki Terakawa,
  • Koji Chiba,
  • Akihisa Yao,
  • Hideaki Miyake

摘要

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.