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