Safety and Efficacy of Lenvatinib Plus Nivolumab in Unresectable Hepatocellular Carcinoma: A Retrospective Study in China

Abstract

Introduction: Combining lenvatinib and programmed cell death-1 immune checkpoint represents a promising treatment strategy for patients in unresectable hepatocellular carcinoma (uHCC). We investigated the efficacy and safety of combined lenvatinib and nivolumab in uHCC in China. Method: Between June 3, 2019, and May 31, 2021, 66 patients received lenvatinib plus nivolumab as first-line and second-line treatment for the uHCC retrospectively analyzed. Patients initiated lenvatinib (8 mg for bodyweight < 60 kg or 12 mg for bodyweight ≥ 60 kg) 3-7 days to confirm tolerability, and then received 14-day treatment cycles of nivolumab (3 mg/kg bodyweight by IV infusion). Results: All the patients had BCLC Stage C. Lenvatinib plus nivolumab was used as first-, second-line treatments in 36 (54.5%) and 30 (45.5%), respectively. An objective response rates (ORR) was recorded in 23 patients (34.8%), while the best overall responses were from 4 complete response (CR) and 19 partial responses (PR), 32 (48.5%) participants had stable disease (SD). Furthermore, the ORR and disease control rates (DCR) in the first-line group were 36.1% and 86.1%, respectively. The ORR and DCR in the second-line group were 33.3% and 80%, respectively. Two patients without extrahepatic metastasis achieved sufficient downstaging to be converted to resectable disease and received curative hepatectomy. One of them achieved pathological CR. All adverse events were expected and manageable, and no treatment-related deaths were reported. Conclusion: Combination lenvatinib with nivolumab showed promising antitumor activity and manageable toxicity in patients with uHCC. Further randomized, controlled trials are warranted to validate our findings.