Randomized Phase II Trial Evaluates Ociperlimab Plus Tislelizumab and BAT1706 in Advanced Hepatocellular Carcinoma
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Key Takeaway
Consider early phase II data showing objective response rates between ociperlimab combinations and tislelizumab plus BAT1706.
This randomized phase II trial was conducted in a multicenter setting involving 94 patients with advanced hepatocellular carcinoma. The study aimed to evaluate the efficacy of a triple combination therapy versus a doublet regimen in this specific population of patients.
Participants received either ociperlimab and tislelizumab plus BAT1706 or tislelizumab plus BAT1706. The primary outcome was objective response rate. The objective response rate was 37.1% for Arm A and 40.6% for Arm B. Values were 37.1% (25.2-50.3) for Arm A and 40.6% (23.7-59.4) for Arm B. No effect size or absolute numbers were reported.
Safety data indicated adverse events occurred in 90.3% of Arm A and 80.6% of Arm B. Discontinuations were recorded at 22.6% for Arm A and 9.7% for Arm B. Tolerability was described as tolerable and manageable, with no new safety signals identified. Serious adverse events were not reported in the dataset. Follow-up duration was not reported. Practice relevance was not reported. Limitations were not reported in the provided data. These early phase results suggest a need for larger confirmatory studies to establish clinical utility and confirm safety profiles in this population. The study design was randomized.
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View Original Abstract ↓
BACKGROUND: Patients with hepatocellular carcinoma (HCC) have an unmet need for new therapies that improve survival. This phase II trial investigated the efficacy and safety of ociperlimab and tislelizumab plus BAT1706 (a bevacizumab biosimilar) in patients with first-line HCC.
METHODS: In this phase II, multicenter, randomized, multi-arm, open-label trial, patients with advanced HCC received ociperlimab and tislelizumab plus BAT1706 (Arm A) or tislelizumab plus BAT1706 (Arm B). The primary objective was to evaluate efficacy using objective response rate (ORR) assessed by the investigator per RESIST v1.1 for Arms A and B.
RESULTS: 94 patients were randomized to Arm A (N = 62) and Arm B (N = 32). Confirmed ORR (95% confidence interval) was 37.1% (25.2-50.3) for Arm A and 40.6% (23.7-59.4) for Arm B. In Arms A and B, respectively, 90.3% and 80.6% of patients experienced treatment-related treatment-emergent adverse events (TEAEs), 59.7% and 32.3% experienced Grade ≥ 3 treatment-related TEAEs and 22.6% and 9.7% experienced treatment-related TEAEs leading to treatment discontinuation. Immune-mediated adverse events were reported in 50.0% of patients in Arm A and 45.2% of patients in Arm B. Infusion-related reactions occurred in a single patient in Arm A.
CONCLUSION: In patients with advanced HCC, tislelizumab plus BAT1706 demonstrated promising ORR, while adding ociperlimab was not associated with improved efficacy. The safety profile of ociperlimab and tislelizumab plus BAT1706 was tolerable and manageable, with no new safety signals identified.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT04948697 (September 20, 2021).
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