Tislelizumab Deemed Potential First-Line Option for HCC

Tislelizumab may be a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC), according to researchers.

In a phase 3 trial, the researchers found that tislelizumab improved responses over sorafenib. The 2 treatments conferred similar progression-free survival (PFS) and overall survival (OS). These results were published in JAMA Oncology.

The trial, RATIONALE-301 (ClinicalTrials.gov identifier: NCT03412773), included 674 patients with HCC who had not received prior systemic therapy. The patients’ median age was 61 (range, 23-86) years, and 15.4% were women.

The patients were randomly assigned to receive tislelizumab at 200 mg every 3 weeks (n=342) or sorafenib at 400 mg twice daily (n=332) until disease progression, unacceptable toxicity, or study withdrawal. Baseline characteristics were well balanced between the treatment arms.

The primary endpoint — noninferiority of OS — was met. The median OS was 15.9 months with tislelizumab and 14.1 months with sorafenib (hazard ratio [HR], 0.85; 95% CI, 0.71-1.02).

The median PFS was 2.1 months with tislelizumab and 3.4 months with sorafenib (HR, 1.11; 95% CI, 0.92-1.33).

The objective response rate was 14.3% with tislelizumab and 5.4% with sorafenib. There were 10 complete responses in the tislelizumab arm and 1 in the sorafenib arm. The median duration of response was 36.1 months with tislelizumab and 11.0 months with sorafenib.

The rate of treatment-related adverse events (TRAEs) was 76.6% in the tislelizumab arm and 96.0% in the sorafenib arm. The rate of grade 3 or higher TRAEs was 22.2% and 53.4%, respectively. There were 3 patients in the tislelizumab arm and 2 in the sorafenib arm who died due to a TRAE.

The most common TRAEs (in the tislelizumab and sorafenib arms, respectively) were AST increase (23.1% vs 28.7%), ALT increase (16.6% vs 25.0%), blood bilirubin increase (12.4% vs 20.7%), diarrhea (5.6% vs 39.2%), hypertension (2.7% vs 24.7%), alopecia (0.3% vs 22.5%), and palmar-plantar erythrodysesthesia syndrome (0.3% vs 62.7%).

Based on these results, the researchers concluded that “tislelizumab represents a potential first-line treatment option for patients with unresectable HCC.”

Disclosures: This study was supported by BeiGene, Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Qin S, Kudo M, Meyer T, et al. Tislelizumab vs sorafenib as first-line treatment for unresectable hepatocellular carcinoma. A phase 3 randomized clinical trial. JAMA Oncol. Published online October 5, 2023. doi:10.1001/jamaoncol.2023.4003

This article originally appeared on Cancer Therapy Advisor