Ambezhu (bevacizumab biosimilar) / Sinocelltech - LARVOL DELTA

Population Pharmacokinetics of SCT510 (a Bevacizumab Biosimilar) and Avastin® in Healthy Subjects and Patients with Non-squamous Non-small Cell Lung Cancer. (PubMed, Clin Drug Investig) - P1, P3 | "SCT510 and Avastin® demonstrated comparable population pharmacokinetic profiles, supporting the biosimilarity of SCT510 to its reference product. The analysis also indicated that no clinically relevant differences in exposure were observed for either agent across a wide range of hepatic or renal function, or age. These findings collectively support that no dose adjustment is necessary for these factors."

Journal • PK/PD data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung 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. (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