Final efficacy and safety results and biomarker analysis of a phase 2 study of cabozantinib in Japanese patients with advanced renal cell carcinoma

Noboru Nakaigawa, Yoshihiko Tomita, Satoshi Tamada, Katsunori Tatsugami, Takahiro Osawa, Mototsugu Oya, Hiroomi Kanayama, Yuji Miura, Naoto Sassa, Kazuo Nishimura, Masahiro Nozawa, Naoya Masumori, Yasuhide Miyoshi, Shingo Kuroda, Akiko Kimura

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)


Background: Cabozantinib was established as the standard of care for the treatment of patients with renal cell carcinoma (RCC) whose disease had progressed after vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy in the global randomized trial METEOR. A phase 2 study was conducted to bridge the findings in METEOR to Japanese patients. Here, we report a biomarker analysis and update the efficacy and safety results of cabozantinib treatment. Methods: Japanese patients with RCC who received at least one prior VEGFR-TKI were enrolled and received cabozantinib 60 mg orally once daily. The primary endpoint was objective response rate. Secondary endpoints included progression-free survival, overall survival, and safety. Exploratory analyses included the relationship between plasma protein hepatocyte growth factor (HGF) levels and treatment responses. Results: In total, 35 patients were enrolled. The median treatment duration was 58.3 (range 5.1–131.4) weeks. The objective response rate was 25.7% (90% confidence interval [CI] 14.1–40.6). Kaplan–Meier estimate of median progression-free survival was 11.1 months (95% CI 7.4–18.4). The estimated progression-free survival proportion was 73.1% (95% CI 54.6–85.0) at 6 months. Median overall survival was not reached. Adverse events were consistent with those in METEOR and the safety profile was acceptable. Nonresponders to cabozantinib showed relatively higher HGF levels than responders at baseline. Conclusions: Updated analyses demonstrate the long-term efficacy and safety of cabozantinib in Japanese patients with advanced RCC after at least one VEGFR-TKI therapy. Responders tended to show lower baseline HGF levels Identifier: NCT03339219.

Original languageEnglish
Pages (from-to)416-426
Number of pages11
JournalInternational Journal of Clinical Oncology
Issue number3
Publication statusPublished - 2023 Mar


  • Biomarker
  • Cabozantinib
  • HGF
  • Japanese
  • Renal cell carcinoma
  • Tyrosine kinase inhibitor

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology


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