Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study

Despite the potential of pembrolizumab and lenvatinib combination therapy in treating metastatic renal cell carcinoma (mRCC), real-world evidence on its efficacy and safety remains limited. We retrospectively analyzed data from 118 patients with mRCC who initiated pembrolizumab plus lenvatinib as first-line therapy between August 2022 and March 2024. Patient characteristics, treatment outcomes, and adverse events were evaluated. Oncological outcomes were stratified following the International Metastatic RCC Database Consortium risk classification. The objective response and disease control rates were 69.5% and 98.5%, respectively. Median progression-free survival (PFS) was 26.8 months (95% confidence interval (CI), 23.5-27.8)), whereas the median overall survival (OS) was not reached (95%CI, 20.5- not reached). Grade ≥ 3 treatment-related adverse events occurred in 39.8% of all patients. Clinical outcomes were also compared between patients aged ≥ 75 and < 75 years. Median age was 70 years; 70.3% and 29.7% aged < 75 and ≥ 75 years, respectively. No significant differences were observed in PFS and OS between the two groups (p = 0.14 and p = 0.44, respectively). Pembrolizumab plus lenvatinib demonstrated favorable efficacy and manageable safety in a real-world cohort of patients with mRCC, including older adults.

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Journal
Scientific Reports
Published
2025-12-12
DOI
https://doi.org/10.1038/s41598-025-27578-6
Citations
1
Primary Topic
Renal cell carcinoma treatment
Type
article
Field-Weighted Citation Impact
1.52
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article

Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study

Tetsuya Takao, Masao Tsujihata, Hitoshi Takayama, Hiromu Horitani et al.
1 citations
Scientific Reports
Renal cell carcinoma treatment
1.52
article

Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study

Tetsuya Takao, Masao Tsujihata, Hitoshi Takayama, Hiromu Horitani, Koji Hatano, Atsunari Kawashima, Yu Ishizuya, Takuji Hayashi, Ken‐ichi Kakimoto, Yutaka Ono, Shingo Takada, Shingo Toyoda, Toshichika Iwanishi, Hiroki Osaki, Mototaka Sato, Kazutoshi Fujita, Masashi Nakayama, Kensaku Nishimura, Koichi Okada, Norio Nonomura, Taigo Kato, Osamu Miyake, Yoshiyuki Yamamoto, Yasutomo Nakai
article en
1 citations

Abstract

Despite the potential of pembrolizumab and lenvatinib combination therapy in treating metastatic renal cell carcinoma (mRCC), real-world evidence on its efficacy and safety remains limited. We retrospectively analyzed data from 118 patients with mRCC who initiated pembrolizumab plus lenvatinib as first-line therapy between August 2022 and March 2024. Patient characteristics, treatment outcomes, and adverse events were evaluated. Oncological outcomes were stratified following the International Metastatic RCC Database Consortium risk classification. The objective response and disease control rates were 69.5% and 98.5%, respectively. Median progression-free survival (PFS) was 26.8 months (95% confidence interval (CI), 23.5-27.8)), whereas the median overall survival (OS) was not reached (95%CI, 20.5- not reached). Grade ≥ 3 treatment-related adverse events occurred in 39.8% of all patients. Clinical outcomes were also compared between patients aged ≥ 75 and < 75 years. Median age was 70 years; 70.3% and 29.7% aged < 75 and ≥ 75 years, respectively. No significant differences were observed in PFS and OS between the two groups (p = 0.14 and p = 0.44, respectively). Pembrolizumab plus lenvatinib demonstrated favorable efficacy and manageable safety in a real-world cohort of patients with mRCC, including older adults.

Scientific ReportsVol. 15(1)
Osaka Prefectural Medical Center (JP), Osaka City University (JP), Toyonaka Municipal Hospital (JP), Osaka National Hospital (JP), Kindai University Hospital (JP), Osaka City General Hospital (JP), Sakai Municipal Hospital (JP), Osaka Police Hospital (JP), Osaka Rosai Hospital (JP), Higashi Osaka City General Hospital (JP), Osaka International Cancer Institute (JP), Nippon Medical School Hospital (JP), Kindai University (JP), The University of Osaka (JP)
Openalex Percentile: Top 12%
Renal cell carcinoma treatment
1.52
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