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A Phase 1b Study of Lenvatinib plus Nivolumab in Patients with Unresectable Hepatocellular Carcinoma - PubMed

4 hours ago
  • #Lenvatinib
  • #Nivolumab
  • #Hepatocellular carcinoma
  • Phase 1b study evaluates lenvatinib + nivolumab in unresectable hepatocellular carcinoma (uHCC).
  • Study conducted in Japan with adults (≥20 years) with confirmed HCC.
  • Patients received lenvatinib (8 mg or 12 mg daily) + nivolumab (240 mg every 2 weeks).
  • No dose-limiting toxicities (DLTs) observed in part 1 (n=6).
  • Treatment-related adverse events (TRAEs) occurred in all patients (n=30), most common being palmar-plantar erythrodysesthesia (60%).
  • Objective response rate (ORR) was 66.7% (part 1) and 79.2% (part 2) by mRECIST.
  • Median progression-free survival (PFS) was 9.07 months, and median overall survival (OS) was 26.94 months in part 2.
  • Lenvatinib + nivolumab was well-tolerated and showed promising antitumor activity in advanced uHCC.