Lenvatinib Plus Tislelizumab Offers Antitumor Activity for First-line Treatment of uHCC

Lenvatinib is a common treatment for patients with unresectable hepatocellular carcinoma (uHCC), and has been used in combination with pembrolizumab for diseases including renal cell carcinoma and endometrial carcinoma.

As the benefit of lenvatinib with immunotherapy in HCC needs to be further verified, a new study by Li Xu, MD, and colleagues examined the efficacy and safety of tislelizumab with lenvatinib in systemic treatment-naïve patients with uHCC.

The multicenter, single-arm, phase 2 study enrolled 64 patients across 9 research sites in China. Each patient received tislelizumab 200 mg every 3 weeks in addition to lenvatinib once daily (bodyweight ≥ 60 kg: 12 mg; < 60 kg: 8 mg).

Safety analyses were performed in the safety analysis set (SAS), which included all patients who received at least 1 dose of tislelizumab or Lenvatinib. Patients in the SAS who had measurable disease at baseline and at least 1 evaluable post-baseline tumor assessment were placed in the efficacy evaluable analysis set (EAS), where all efficacy analyses were conducted.

The primary endpoint was objective response rate (ORR), while secondary endpoints were safety and tolerability, disease control rate, and progression-free survival (PFS).

A total of 62 patients in the EAS set were evaluated. After a median follow-up of 15.7 months, the ORR and disease control rates were 38.7% (24/62, 95% CI, 26.6–51.9) and 90.3% (56/62, 95% CI, 80.1–96.4), respectively.

The median PFS was 8.2 months (95% CI, 6.8–not evaluable), and the overall survival rate at 12 months was 88.6% (95% CI, 77.7–94.4). Grade ≥ 3 treatment-related adverse events occurred in 18 (28.1%) patients. No dose-limiting toxicities were reported.

The combination treatment of tislelizumab plus lenvatinib can offer promising antitumor activity and tolerability as a first-line treatment for patients with uHCC.