Real‐world effectiveness of lenvatinib monotherapy in previously treated unresectable hepatocellular carcinoma in US clinical practice

BACKGROUND: Lenvatinib monotherapy was approved in the United States for first‐line treatment of patients with unresectable hepatocellular carcinoma (uHCC) in 2018. This study assessed real‐world treatment patterns and outcomes of lenvatinib beyond first‐line systemic treatment in the United States. METHODS: A retrospective study was conducted among US adults (≥18 years) with uHCC. Eligible patients initiated lenvatinib monotherapy as second‐ or later‐line systemic therapy (2L‐plus) from August 2018 to September 2019. Clinical outcomes included physician‐reported best response, progression‐free survival (PFS), and overall survival (OS). RESULTS: Of 164 patients who received lenvatinib in 2L‐plus, most (n = 133; 81.1%) received lenvatinib in 2 L. There were 109 patients (66.4%) who initiated lenvatinib after immunotherapy. At lenvatinib initiation, only 31.1% of patients had Child‐Pugh class A, while half (49.4%) had Child‐Pugh class B. Most patients had Barcelona Clinic Liver Cancer stage B (23.8%) or C (38.4%) uHCC. Median duration of lenvatinib treatment was 6.9 months, with 42.7% of patients still on treatment at the end of follow‐up. Physician‐reported best response was complete and partial response for 8.5% and 44.5% of patients, respectively. PFS and OS rate estimates from lenvatinib initiation at 12 months were 51.7% and 57.8%, respectively. Among patients treated after immunotherapy, complete and partial responses were 10.1% and 43.1%, respectively, and PFS and OS estimates from lenvatinib initiation at 12 months were 52.8% and 60.0%, respectively. CONCLUSION: This retrospective study suggests clinical effectiveness of lenvatinib monotherapy in a real‐world setting among previously treated patients with uHCC, including among those previously treated with immunotherapy.