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Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage
Chuanhua Zhao1, Yanqiao Zhang2, Gang Wang3
1Department of Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.
Abstract:
We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. This randomized phase 2 and 3 study (ClinicalTrials.gov, NCT04560894; Chinadrugtrials.org.cn, CTR20201976 and CTR20201974) was performed at 67 hospitals in China. HCC patients (n = 398) were included between 11 November 2020 and 28 September 2022. In phase 2, patients received intravenous finotonlimab (200 mg every 3 weeks) combined with SCT510 (15 mg/kg every 3 weeks). In phase 3, 346 patients were randomized (2:1) to either the finotonlimab plus SCT510 (dual-agent) group or the sorafenib group. The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months, respectively. Median PFS, assessed by BICR according to RECIST 1.1, was significantly longer in the dual-agent group (7.1 months [95% confidence intervals {CI}: 6.1, 8.4]) than in the sorafenib group (2.9 months [95% CI: 2.8, 4.1]; stratified hazard ratio [HR]: 0.5, 95% CI: 0.38, 0.65, p < 0.0001). Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], p < 0.0008). Finotonlimab in combination with bevacizumab demonstrated favorable efficacy, in comparison to sorafenib, as a first-line treatment for unresectable HCC, with a manageable safety profile.
Insights
First-line treatment with finotonlimab plus SCT510 (bevacizumab biosimilar) significantly improved progression-free survival and overall survival in patients with unresectable advanced hepatocellular carcinoma (HCC) compared to sorafenib.
Area of Science:
- Oncology
- Immunotherapy
- Hepatocellular Carcinoma Research
Background:
- Unresectable advanced hepatocellular carcinoma (HCC) remains a significant clinical challenge with limited first-line treatment options.
- Sorafenib has been a standard first-line treatment, but outcomes can be improved.
Purpose of the Study:
- To evaluate the efficacy and tolerability of finotonlimab (anti-programmed cell death protein-1 antibody) combined with SCT510 (bevacizumab biosimilar) as a first-line treatment for unresectable advanced HCC.
- To compare this combination therapy against sorafenib in a randomized phase 2/3 study.
Main Methods:
- A randomized phase 2/3 study involving 398 HCC patients in China.
- Phase 3 randomized 346 patients to either finotonlimab plus SCT510 (dual-agent) or sorafenib.
- Median follow-up was approximately 19-20 months, with efficacy assessed by blinded independent central review (BICR) using RECIST 1.1 criteria.
Main Results:
- The dual-agent group showed significantly longer median progression-free survival (PFS) (7.1 months vs. 2.9 months; HR: 0.5; p < 0.0001).
- Median overall survival (OS) was also significantly longer in the dual-agent group (22.1 months vs. 14.2 months; HR: 0.60; p < 0.0008).
- The combination therapy demonstrated a manageable safety profile.
Conclusions:
- Finotonlimab in combination with SCT510 (bevacizumab biosimilar) is an effective first-line treatment for unresectable advanced HCC.
- This dual-agent therapy offers a significant survival benefit over sorafenib.
- The combination presents a favorable efficacy and safety profile for HCC management.
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