Andewei (benmelstobart) / Apollomics, Sino Biopharm - LARVOL DELTA

Preliminary results of ALTER-PA-001 trial: A multicenter, open-label, randomized, phase II trial of anlotinib and benmelstobart in combination with AG versus AG as first-line treatment for metastatic pancreatic cancer. (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06621095 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Preliminary results of benmelstobart (BEN) combined with concurrent chemoradiotherapy (cCRT) versus cCRT alone as neoadjuvant therapy for esophageal squamous cell carcinoma (ESCC): A multicentre, randomised study. (ASCO-GI 2026) - P2 | "Funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Clinical Trial Registration Number: NCT06637163 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

First line PD-L1/1 inhibition based therapies in elderly patients with ES-SCLC: a Systematic Literature Review and Network Meta-Analysis (ESMO-IO 2025) - "Currently, PD-1/PD-L1 inhibitors with platinum and etoposide (EP) have been adopted as standard first-line therapy and idemonstrated survival benefits in the overall population, while the magnitude of benefit and optimal agent in elderly patients remain unclear.Methods Following PRISMA-NMA guidelines, PubMed and ClinicalTrials.gov were searched up to 29 August 2025. Eligible RCTs compared first-line PD-L1 or PD-1 inhibitors—atezolizumab, durvalumab, serplulimab, adebrelimab, tislelizumab, pembrolizumab, socazolimab, benmelstobart(+anlotinib), nivolumab, or toripalimab with or without EP in ES-SCLC...Atezolizumab-EP ranked highest for OS (SUCRA=0.88), followed by Benmelstobart + anlotinib -EP (SUCRA = 0.86) and serplulimab-EP (SUCRA = 0.77), whereas durvalumab-EP (SUCRA = 0.36) and socazolimab-EP (SUCRA = 0.29) showed relatively modest effects.Conclusions First-line PD-L1/PD-1 inhibition plus EP confers a clinically meaningful survival advantage in elderly patients with..."

Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Adjuvant benmelstobart plus anlotinib in patients with high-risk recurrence after resection of hepatocellular carcinoma: a phase II study (ALTER-H006). (PubMed, Nat Commun) - P2 | "No treatment-related deaths occur. Here, we show that adjuvant benmelstobart plus anlotinib is a feasible treatment option for HCC patients with high-risk recurrence after HCC resection, warranting confirmation in large-scale randomized clinical trials."

Clinical • Journal • P2 data • Cardiovascular • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • Thrombosis

Synergistic chemo-free regimen: A Phase II trial of immunoradiotherapy combined with PD-L1 inhibitor benmelstobart and anlotinib as a treatment for advanced HER2-negative breast cancer [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Preliminary results of a multicenter, open-label, randomized, phase II trial (ALTER-PA-001 trial) of anlotinib and benmelstobart in combination with AG versus AG as first-line treatment for metastatic pancreatic cancer (ESMO-IO 2025) - P2 | "Background Nab-paclitaxel and gemcitabine (AG) are standard first-line therapy in metastatic pancreatic cancer (mPC) with limited efficacy. The incidence of TEAE were 85.7% and 86.7% in Anlotinib and AG group, respectively. Grade≥3 TEAE occurred in 32.1% and 33.3% of patients, respectively.Conclusions The preliminary results had demonstrated a potent efficacy of anlotnib plus benmelstobart and AG as first-line treatment for mPC patients, with a manageable safety profile.Clinical trial identification NCT06621095.Legal entity responsible for the study The authors."

Clinical • Combination therapy • Metastases • P2 data • Oncology • Pancreatic Cancer • Solid Tumor

Immune checkpoint inhibitors for extensive-stage small-cell lung cancer: a network meta-analysis and cost-effectiveness analysis. (PubMed, Front Immunol) - "NMA demonstrated that benmelstobart and anlotinib plus chemotherapy ranked first in improving OS (HR = 0.81, 95% CI: 0.72-0.90), PFS (HR = 0.61, 95% CI: 0.55-0.67), and ORR (OR = 2.16, 95% CI: 1.43-3.27) compared to chemotherapy. Serplulimab plus chemotherapy ranked second in OS (HR = 0.82, 95% CI: 0.73-0.91) and PFS (HR = 0.73, 95% CI: 0.66-0.80)...And none of the evaluated ICI-based regimens were cost-effective at the conventional WTP threshold. However, tislelizumab plus chemotherapy was the most cost-effective as the WTP threshold increased."

Checkpoint inhibition • Clinical • HEOR • Journal • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Surgery after induced anti-PD-L1 therapy and chemotherapy for stage I‒III small-cell lung cancer: a phase 2 trial (LungMate-005). (PubMed, Cell Discov) - P2 | "Eligible patients received four cycles of anti-PD-L1 antibody (TQB2450) therapy and chemotherapy, followed by surgery or radiotherapy and one-year maintenance immunotherapy (TQB2450)...We demonstrated that PRSS8 was a potential biomarker for poor effectiveness of immunochemotherapy. In conclusion, surgery after neoadjuvant immunochemotherapy is feasible for treating patients with stage I‒III small-cell lung cancer."

IO biomarker • Journal • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PRSS8

TQB2102-II-03: A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Trial completion date: Feb 2026 ➔ Dec 2026 | Trial primary completion date: Oct 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Combination Therapy with Hypofractionated Radiotherapy, GM-CSF, and Benmelstobart Followed by Bemzutizumab Plus Anlotinib Maintenance in Driver Mutation-Negative Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients Who Failed Prior PD-1/PD-L1 Inhibitor Therapy: A Single-Arm Exploratory Study (ChiCTR) - P2 | N=69 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Nanjing Medical University; The Second Affiliated Hospital of Nanjing Medical University

IO biomarker • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors (ChiCTR) - P2 | N=60 | Recruiting | Sponsor: The Second Affiliated Hospital of Shandong First Medical University; The Second Affiliated Hospital of Shandong First Medical University

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Solid Tumor

Cost effectiveness and pricing strategy of first line benmelstobart combination treatment for extensive stage small cell lung cancer in China. (PubMed, Sci Rep) - "Benmelstobart plus anlotinib and carboplatin/etoposide was unlikely to be the cost-effective first-line strategy compared with anlotinib plus carboplatin/etoposide and carboplatin plus etoposide for ES-SCLC patients in China. Reducing the price of benmelstobart could increase its cost-effectiveness."

HEOR • Journal • Pricing • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase II Clinical Trial of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma [WITHDRAWN] (ESMO 2025) - No abstract available

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

Cost effectiveness and pricing strategy of first line benmelstobart combination treatment for extensive stage small cell lung cancer in China (Nature) - "For intention-to-treat (ITT) patients, benmelstobart plus anlotinib and carboplatin/etoposide could bring additional 0.60 and 0.71 QALYs with marginal cost of $91,424.86 and $98,504.86 compared with anlotinib plus carboplatin/etoposide and carboplatin plus etoposide, respectively, resulting in an incremental cost-effectiveness ratios (ICERs) were $153,444.29/QALY and $138,272.39/QALY, respectively, which were higher than the Chinese willingness-to-pay (WTP) threshold. Sensitivity analyses and subgroup analyses confirmed the robustness of the model results when parameters changed. Benmelstobart plus anlotinib and carboplatin/etoposide was unlikely to be the cost-effective first-line strategy compared with anlotinib plus carboplatin/etoposide and carboplatin plus etoposide for ES-SCLC patients in China."

HEOR • Small Cell Lung Cancer

TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial (ESMO 2025) - P2 | "The results showed promising efficacy and a manageable safety profile for this combination. Plasma EBV DNA change is the potential efficacy predictive biomarker."

Clinical • IO biomarker • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: An open-label, single-arm, phase II trial. (PubMed, Med) - P2 | "This combination therapy shows promising efficacy with a manageable safety profile in rNPC patients. Determination of MIF levels, tumor microenvironment characteristics, TCR profiling, and serial EBV DNA monitoring could identify patients who derive benefits from this therapeutic approach."

IO biomarker • Journal • P2 data • Epstein-Barr Virus Infections • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • MIF

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Durable Survival and Updated Safety of TQB2450 plus Anlotinib Maintenance Therapy in Limited-Stage Small Cell Lung Cancer: Extended Follow-Up from a Prospective Phase Ib Trial (ASTRO 2025) - P1, P3 | "The combination of TQB2450 and Anlotinib demonstrated durable efficacy with manageable toxicity in patients with LS-SCLC who have not experienced disease progression after first-line therapy. To validate these preliminary findings, a randomized, double-blind, placebo-controlled phase III clinical trial is currently underway, aiming to offer robust evidence for its integration into clinical practice. The trial is registered with ClinicalTrials.gov, NCT05942508."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Cost-effectiveness analysis of benmelstobart and anlotinib plus chemotherapy versus standard chemotherapy in first-line treatment for extensive-stage small cell lung cancer: Perspectives from the United States and China. (PubMed, PLoS One) - "The combination of benmelstobart and anlotinib with chemotherapy is not a cost-effective first-line treatment option for ES-SCLC in either China or the US."

HEOR • Journal • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Anlotinib and Benmelstobart in DTC (clinicaltrials.gov) - P2 | N=23 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma

Efficacy and safety of immunotherapy or antiangiogenic agent-based treatment strategies versus chemotherapy as first-line treatment for extensive-stage small cell lung cancer: a network meta-analysis. (PubMed, Front Pharmacol) - "Immune checkpoint inhibitors (ICIs) combined with etoposide-platinum are recommended as the standard first-line therapy for extensive-stage small cell lung cancer (ES-SCLC)...The drug combination patterns included ipilimumab, durvalumab, adebrelimab, atezolizumab, socazolimab, pembrolizumab, serplulimab, tislelizumab, toripalimab, durvalumab + tremelimumab, tiragolumab + atezolizumab, benmelstobart + anlotinib, bevacizumab + atezolizumab, anlotinib, bevacizumab in combination with chemotherapy...The toxicity of ICI + Antiangio + Chemo was acceptable but needed careful attention. These findings clarified the roles of ICIs and antiangiogenic agent-based treatment strategies in this population."

Journal • Retrospective data • Review • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Case Report: Synergistic multimodal therapy in SMARCA4-deficient undifferentiated tumor: integrating chemotherapy, anti-angiogenesis immunotherapy, and radiotherapy for enhanced outcomes. (PubMed, Front Oncol) - "Sequential PET/CT imaging demonstrated metabolic regression of the primary tumor and metastatic lesions following chemotherapy combined with anti-angiogenic therapy (anlotinib) and PD-L1 inhibition (benmelstobart), followed by consolidative radiotherapy. This case highlights the potential of a mechanistic-driven, multimodal strategy to overcome therapeutic resistance in SMARCA4-deficient undifferentiated tumor. It underscores the need for further exploration of synergistic regimens in this molecular subset."

Journal • Oncology • Thoracic Cancer • SMARCA4

Open-Label, Biomarker-Integrated Umbrella Trial for First-Line Treatment of Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=165 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

Biomarker • IO biomarker • New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of First-Line Chemotherapy-Based Combination Therapy for Patients With Extensive-Stage Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, Clin Med Insights Oncol) - "In patients with baseline liver metastases, this regimen provided the greatest PFS benefit (99%), whereas serplulimab plus chemotherapy offered the best OS (53%). For treatment-naïve ES-SCLC patients, benmelstobart plus anlotinib plus chemotherapy yielded the most favorable outcomes in terms of PFS, OS and ORR, but a less favorable safety profile. These findings support its use as a potent therapeutic option in few patient populations."

Journal • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of DEB-TACE combined with transarterial TQB2450 infusion and oral Anlotinib as first-line treatment in advanced hepatocellular carcinoma: a single-arm phase II study. (PubMed, Front Immunol) - P4 | "These findings support further investigation in randomized controlled trials. Chinese Clinical Trials Database (ChiCTR2200056222)."

Journal • P2 data • Hematological Disorders • Hepatocellular Cancer • Oncology • Solid Tumor • Thrombocytopenia