Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma
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Discussion
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Implication
Randomized noninferiority trial demonstrates comparable overall survival with tislelizumab versus sorafenib in advanced hepatocellular carcinoma, indicating a tolerable new first-line option.
Key Points
- To assess the efficacy and safety of tislelizumab compared with sorafenib as first-line therapy for patients with unresectable hepatocellular carcinoma.
- Open-label, global, phase 3 randomized clinical trial (RATIONALE-301; NCT03412773) conducted between December 2017 and October 2019.
- Enrolled 674 systemic therapy-naive adults with histologically confirmed BCLC stage B or C unresectable hepatocellular carcinoma and Child-Pugh class A liver function.
- Patients were randomized 1:1 to receive intravenous tislelizumab (200 mg every 3 weeks) or oral sorafenib tosylate (400 mg twice daily) with a minimum follow-up of 33 months.
- Tislelizumab demonstrated noninferior overall survival compared to sorafenib, with a median overall survival of 15.9 months (95% CI, 13.2-19.7) versus 14.1 months (95% CI, 12.6-17.4) (HR, 0.85 [95.003% CI, 0.71-1.02]), but superiority was not met.
- The objective response rate was 14.3% (n = 49) with tislelizumab versus 5.4% (n = 18) with sorafenib, with a median response duration of 36.1 months versus 11.0 months, while median progression-free survival was 2.1 months versus 3.4 months (HR, 1.11 [95% CI, 0.92-1.33]).
- Grade 3 or higher treatment-related adverse events occurred in 22.2% (75/338) of patients receiving tislelizumab compared with 53.4% (173/324) receiving sorafenib, leading to lower discontinuation rates (6.2% vs 10.2%).
Cite This Study
Qin et al. (2023) studied this question.