On February 25th, 2025,China’s National Medical Products Administration (NMPA) has approved finotonlimab in combination with SCT510 for the treatment of unresectable or metastatic hepatocellular carcinoma that has not received prior systemic therapy.
Finotonlimab is a recombinant humanized IgG4 subtype anti-PD-1 monoclonal antibody with complete intellectual property rights. As a patented new drug, its molecular structure is unique and has mechanism advantages. Finotonlimab binds to PD-1 with high affinity, effectively blocking the PD-1/PD-L1 pathway, restoring and enhancing the immune killing function of T cells, and thereby inhibiting tumor growth.
At ASCO Annual Meeting 2024，reported a randomized phase 3 trial of SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma.
In this open-label, multicenter, phase 3 trial (NCT04560894) conducted in China, patients with advanced HCC who had not received prior system therapy were enrolled and randomly assigned (2:1) to receive SCT-I10A (200 mg every three weeks [Q3W]) plus SCT510 (a bevacizumab biosimilar, 15 mg/kg Q3W) or sorafenib (400 mg orally twice daily) until no clinical benefit or unacceptable toxicity. Randomization was stratified by ECOG performance status (0 vs. 1), baseline alpha-fetoprotein level (<400ng/ml vs. ≥400ng/ml), macrovascular invasion or extrahepatic metastasis (yes vs. no). The co-primary endpoints were overall survival (OS) and progression-free survival (PFS) as assessed by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the full analysis set.
At the data cutoff for the interim analysis (November 2, 2023), a total of 346 patients were enrolled and received at least one dose (SCT-I10A plus SCT510 group, n=230; sorafenib group, n=116), and the median follow-up was 19.7 months. The SCT-I10A plus SCT510 group exhibited a significantly longer median OS than that in the sorafenib group (22.1 vs. 14.2 months, hazard ratio [HR] 0.60; 95% confidence interval [CI]: 0.44, 0.81; p=0.0008). Median PFS was prolonged significantly in the SCT-I10A plus SCT510 group compared to the sorafenib group (7.1 vs. 2.9 months; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). The objective response rate (ORR) was higher in the SCT-I10A plus SCT510 group (32.8% [75/229]) than in the sorafenib group (4.3% [5/116]). Grade ≥3 treatment-related adverse events (TRAEs) were observed in 42.6% (98/230) of patients in the SCT-I10A plus SCT510 group and 33.6% (39/116) of patients in the sorafenib group. The most common grade ≥3 TRAE was hypertension (SCT-I10A plus SCT510 group vs. sorafenib group: 7.8% [18/230] vs. 4.3% [5/116]). Three drug-related deaths (unknown cause, hemorrhage intracranial, or upper gastrointestinal hemorrhage in 1 patient each) occurred and were related to SCT510.
Conclusions: The combination of SCT-I10A and SCT510 showed substantial clinical advantages and an acceptable safety profile in patients with advanced HCC, thereby supporting its suitability as a first-line treatment option for HCC.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
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Post time: Mar-10-2025