Ambezhu (bevacizumab biosimilar) / Sinocelltech - LARVOL DELTA

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. (PubMed, Signal Transduct Target Ther) - P2/3 | "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. 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."

Clinical • Journal • P2/3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial (Nature) - P2/3 | N=405 | NCT04560894 | Sponsor: Sinocelltech Ltd. | "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...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)."

P2/3 data • Hepatocellular Cancer

Neoadjuvant CAPOX plus SCT510 (bevacizumab biosimilar) and finotonlimab in high-risk resectable colorectal liver metastases (CRLM): A multicenter, phase II study (ESMO Asia 2024) - P4 | "Pts will receive 3 cycles of CAPOX (130 mg/m 2 oxaliplatin, day [D] 1 + 1000 mg/m 2 capecitabine, D1-14, bid), SCT510 (7.5 mg/kg, D1) and finotonlimab (200 mg, D1), followed by 1 cycle of CAPOX plus finotonlimab in 21-day cycle. The primary endpoint is pathologic complete response. Secondary endpoints include 1-year progression-free survival rate, major pathological response, R0 resection, R1 resection, and safety."

Clinical • P2 data • Oncology • Solid Tumor

Efficacy and Safety of Biosimilar SCT510 Compared with Bevacizumab for the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study. (PubMed, Adv Ther) - P3 | "SCT510 is similar to bevacizumab in clinical efficacy, safety, immunogenicity, and PK in patients with advanced non-squamous NSCLC. The totality of the evidence supports the clinical equivalence of SCT510 and bevacizumab."

Clinical • Journal • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial. (ASCO 2024) - P2/3 | "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."

Clinical • Metastases • P3 data • Cardiovascular • Cerebral Hemorrhage • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • AFP

SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3 | N=405 | Active, not recruiting | Sponsor: Sinocelltech Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of SCT510 to Bevacizumab (Avastin) in Healthy Chinese Males. (PubMed, Drugs R D) - P1 | "This study demonstrated that the pharmacokinetics, safety, and immunogenicity of SCT510 were equivalent to bevacizumab (Avastin). As a proposed biosimilar drug to bevacizumab, SCT510 was well tolerated in healthy Chinese males."

Clinical • Journal • P1 data • PK/PD data • Oncology

PK and Safety of SCT510 (clinicaltrials.gov) - P1; N=84; Completed; Sponsor: First Affiliated Hospital of Zhejiang University

Clinical • New P1 trial

HCC: SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3; N=621; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

HCC: SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3; N=621; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • Combination therapy • New P2/3 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

To Evaluate the Efficacy and Safety of SCT510 in the Treatment of Non-small Cell Lung Cancer (clinicaltrials.gov) - P3; N=560; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P3 trial