Anyouping (finotonlimab) / Sinocelltech - LARVOL DELTA

Neoadjuvant finotonlimab plus platinum-taxane chemotherapy for locally advanced HPV-negative head and neck squamous cell carcinoma: a prospective phase II study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: Ji Dongmei | Trial completion date: Sep 2030 ➔ Sep 2031 | Initiation date: Apr 2026 ➔ Sep 2026 | Trial primary completion date: Sep 2030 ➔ Sep 2031

Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cetuximab combined with Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC: an Open-label, Randomized, Prospective, Multicenter phase III Trial (ChiCTR) - P3 | N=316 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P3 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) in patients with advanced esophageal squamous cell carcinoma: A multicenter, open-label, phase 1b clinical trial. (PubMed, Cancer) - P1 | "SCT-I10A plus SCT200 demonstrated durable antitumor activity with a manageable safety profile in previously treated patients with advanced ESCC, even in patients who had previously failed anti-PD-(L)1 therapy."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Phase Ib Trial of Finotonlimab Combined With SCT200 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. (PubMed, Cancer Med) - P1 | "The combination of finotonlimab and SCT200 demonstrates promising efficacy, particularly in systemic therapy-naïve patients, warranting further investigation."

Journal • P1 data • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Clinical Trial Comparing the Efficacy and Safety of Anyouping and Platinum-based Chemotherapy With or Without Enlituo in Advanced Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. (clinicaltrials.gov) - P2/3 | N=362 | Not yet recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd

New P2/3 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Penpulimab Combined With Chemotherapy for Patients With Locally Advanced Hypopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor

Cost-effectiveness analysis of finotonlimab in the treatment of advanced recurrent metastatic head and neck squamous cell carcinoma in China. (PubMed, Hum Vaccin Immunother) - "Scenario analysis showed that a price reduction for finotonlimab could significantly reduce the ICER to near the WTP threshold. Compared with chemotherapy alone, finotonlimab combined with chemotherapy has been determined to be an ineffective, cost-effective therapeutic strategy for the first-line medical treatment of R/M HNSCC in China, and the price discount of finotonlimab can improve its cost-effectiveness."

HEOR • Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Perioperative Finotonlimab Plus Chemotherapy in Untreated Stage II HNSCC (clinicaltrials.gov) - P2 | N=142 | Not yet recruiting | Sponsor: Yanjie Zhang, MD

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cost-effectiveness of finotonlimab plus bevacizumab versus sorafenib as first-line therapy in unresectable hepatocellular carcinoma in China. (PubMed, Hum Vaccin Immunother) - "In PSA, the mean ICER was $50561.81 per QALY, and the probability of cost-effectiveness was 0% at the prespecified threshold. Based on the assumptions and inputs used in the present model, finotonlimab plus bevacizumab was unlikely to be cost-effective compared with sorafenib at the prespecified WTP in China."

Clinical • HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Induction and Adjuvant Finotonlimab Combined with Chemoradiotherapy for T4a-Stage Laryngeal Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Trial (ChiCTR) - P2 | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Laryngeal Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

ICI plus antiangiogenic combinations as first-line therapy for advanced HCC: A systematic review and network meta-analysis (ESMO-GI 2026) - "Background Several ICI plus antiangiogenic combinations have demonstrated OS benefit over sorafenib in phase III trials and received regulatory approval in various jurisdictions for first-line advanced HCC, yet no head-to-head trials exist, and comparative efficacy remains undefined...Table: 218P Conclusions In this NMA, including HEPATORCH (toripalimab–bevacizumab) and the finotonlimab–bevacizumab biosimilar trial, ICI plus anti-VEGF antibody combinations consistently ranked highest for OS in first-line advanced HCC across all analyses. Cabozantinib–atezolizumab was the sole regimen without OS benefit and ranked last among active ICI regimens. These findings may inform treatment selection and guideline development in the absence of direct head-to-head evidence."

Metastases • Retrospective data • Review • Gastrointestinal Cancer • Hepatocellular Cancer

BL-B01D1-210: A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=74 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=46 ➔ 74

Enrollment change • Monotherapy • Hepatocellular Cancer • Oncology • Solid Tumor

Integrating Multiple Outcomes of First-Line Immunotherapy-Based Regimens for Advanced Hepatocellular Carcinoma: A Network Meta-Analysis of Phase III Trials. (PubMed, Crit Rev Oncol Hematol) - "Bevacizumab-based immunotherapy combinations (finotonlimab plus bevacizumab and atezolizumab plus bevacizumab) provide a favorable benefit-risk balance in advanced HCC. The robust performance of finotonlimab plus bevacizumab highlights its translational potential. Composite points such as Topsis may facilitate integrated multiple outcomes."

Journal • P3 data • Retrospective data • Review • Hepatocellular Cancer • Oncology • Solid Tumor

Comparative safety of immune checkpoint inhibitor–chemotherapy regimens across multiple tumor types: A systematic review and network meta-analysis. (ASCO 2026) - "For grade ≥3 irAEs, cumulative ranking probabilities showed that top three safest ICI regimens were adebrelimab (47.0%), avelumab (22.0%) and finotonlimab (21.1%), with pooled OR versus chemotherapy alone of 1.62 (95% CrI 0.28–9.83), 2.78 (95% CrI 0.45–16.08) and 3.38 (95% CrI 0.42-37.26), respectively. This study identifies clinically meaningful differences in safety profiles among ICI plus chemotherapy regimens across multiple solid tumors."

Checkpoint inhibition • Retrospective data • Review • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression (clinicaltrials.gov) - P2 | N=42 | Enrolling by invitation | Sponsor: Sun Yat-sen University

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Economic evaluation of finotonlimab plus bevacizumab as first-line therapy for advanced hepatocellular carcinoma. (PubMed, PLoS One) - "From the perspective of the Chinese healthcare system, finotonlimab combined with a bevacizumab biosimilar is not cost-effective as first-line treatment for advanced HCC."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy of immunotherapy and targeted therapy for unresectable hepatocellular carcinoma: analysis of survival curves. (PubMed, Front Med (Lausanne)) - "Parametric survival modeling suggested that treatment effects varied over time and provided additional insights beyond conventional approaches based on constant HRs. Among the evaluated regimens, finotonlimab plus bevacizumab biosimilar showed a highly favorable efficacy profile; however, long-term comparisons should be interpreted cautiously because they depend partly on extrapolated estimates."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Is PD-1/PD-L1 inhibitor plus bevacizumab superior to sorafenib as first-line treatment for advanced hepatocellular carcinoma? A pooled analysis of four phase 3 RCTs. (PubMed, BMC Gastroenterol) - "PIB demonstrates superior survival and tumor response benefits over sorafenib as initial treatment in patients with advanced HCC, with an acceptable and manageable safety profile."

Journal • P3 data • Retrospective data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Renal Disease • Solid Tumor • PD-1 • PD-L1

LONG'E: Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Beijing Tongren Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: Ji Dongmei

New P3 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A prospective, single-arm, clinical study of finolizumab combined with TP induction regimen in the treatment of resectable locally advanced hypopharyngeal squamous cell carcinoma (ChiCTR) - P1 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Fujian Medical University; The First Affiliated Hospital of Fujian Medical University

New P1 trial • Hypopharyngeal Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Prospective, Single-Arm, Phase II Clinical Study of Finotonlimab Combined with Carboplatin and Nab-Paclitaxel in the Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (ChiCTR) - P2 | N=35 | Not yet recruiting | Sponsor: SUN YAT-SEN MEMORIAL HOSPITAL; SUN YAT-SEN MEMORIAL HOSPITAL

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A prospective, multicenter, randomized, controlled, open-label trial to evaluate the efficacy and safety of Finotonlimab in locally advanced head and neck squamous cell carcinoma (ChiCTR) - P4 | N=292 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P4 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Eye & ENT Hospital of Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor