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

Adebrelimab plus apatinib for maintenance treatment of extensive-stage small cell lung cancer after first-line induction with adebrelimab plus chemotherapy (CLOG2402-ADAPT): a multi-center, single-arm, phase 2 clinical trial (ELCC 2025) - P=N/A, P2 | "The phase III ETER701 clinical trial demonstrated the survival benefits of adding anlotinib to benmelstobart and chemotherapy, but the risks of hemoptysis and occult blood test positive cannot be ignored. The primary endpoint is progression-free survival (PFS). The secondary endpoints include objective response rate, disease control rate, PFS2, duration of response, overall survival, and safety."

Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=134 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Combination Treatment of TLR7 Agonist and Anti-PD-L1 Reconstitute Protective Immunity in Virally Suppressed Chronic Hepatitis B Patients (APASL 2025) - " Totally 24 nucleos(t)ide analogues (NUCs)-treated CHB patients were randomized to receive Entecavir (ETV) monotherapy (n=6), ETV+TQA3334 dual therapy (n=9) or NA+TQA3334+TQB2450 triple therapy (n=9) for 24 weeks and then followed up for 24 weeks. The combination of TLR7 agonist and anti-PD-L1 could reconstitute antiviral immunity in virally suppressed CHB patients by inducing the production of ISGs, antiviral cytokines, and reinvigorating HBV-specific CD8+T cell response, thus potentially favoring improved clinical outcome. Table and Figure:Figure 1.Dual or Triple therapy altered cytokines and ISGs level Figure 2.Triple therapy induces broader and stronger HBV specific CD8+T cells respons"

Clinical • IO biomarker • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD8 • IFNA1 • IFNG • IL21 • ISG15 • MX1 • PD-1 • TNFA

Efficacy and safety of TQB2450 combined with anlotinib as maintenance therapy for LS-SCLC after definitive concurrent or sequential chemoradiotherapy: a prospective phase Ib study. (PubMed, BMC Cancer) - P1, P3 | "TQB2450 combined with Anlotinib showed promising efficacy and well tolerance in patients with LS-SCLC following first-line treatment. A randomized, double-blind, placebo-controlled Phase III clinical study (ClinicalTrials.gov Identifier: NCT06469879) is being conducted to further explore the efficacy and safety of TQB2450 combined with Anlotinib as maintenance therapy after definitive CCRT or SCRT for LS-SCLC."

Clinical • Journal • P1 data • CNS Disorders • Fatigue • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Cost-effectiveness of benmelstobart and anlotinib plus chemotherapy as first-line therapy for extensive-stage small cell lung cancer in China. (PubMed, Sci Rep) - "This study was designed to assess the cost-effectiveness of benmelstobart (B) and anlotinib (A) plus etoposide and carboplatin (EC) as first-line treatment options for patients with ES-SCLC in China. B + A + EC and A + EC are considered unlikely to be cost-effective strategies for first-line treatment of ES-SCLC in China. However, reducing the costs of benmelstobart and anlotinib may enhance the cost-effectiveness of these treatment regimens."

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

Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03) (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Alone or Combined with Anlotinib Administered Prior to Surgery in Terms of Pathological Complete Response (clinicaltrials.gov) - P2 | N=58 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Chemotherapy: Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer (clinicaltrials.gov) - P2 | N=56 | Not yet recruiting | Sponsor: Jiangsu Cancer Institute & Hospital

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

Efficacy and safety of first-line immunotherapy-based regimens for patients with extensive-stage small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Transl Lung Cancer Res) - "The Bayesian ranking probabilities showed that Anl/Ben/CT ranked first and serplulimab plus chemotherapy ranked second in both PFS and OS among 15 regimens. Adding anlotinib and benmelstobart to chemotherapy significantly improved PFS and OS compared with chemotherapy alone or chemotherapy plus immunotherapy, with an acceptable safety profile in patients with ES-SCLC. In conclusion, Anl/Ben/CT could be a new, preferable first-line treatment option but further clinical studies are needed to validate its efficacy and safety."

Journal • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

Etoposide Plus Benmelstobart Followed by Maintenance Therapy of Benmelstobart Plus Anlotinib in First-line Treatment of Elderly Patients with Extensive Stage Small Cell Lung Cancer: a Single-arm, Prospective Trial (clinicaltrials.gov) - P=N/A | N=29 | Not yet recruiting | Sponsor: Nanjing First Hospital, Nanjing Medical University

New trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50) (clinicaltrials.gov) - P2 | N=47 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Jan 2024

Enrollment open • Trial initiation date • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A single-arm exploratory study of TACE combined with Anlotinib hydrochloride capsule and TQB2450 in first-line treatment of patients with advanced liver cancer (ChiCTR) - P4 | N=50 | Recruiting | Sponsor: Henan Cancer Hospital; Henan Cancer Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Solid Tumor

Updated results of ALTER-H006: A phase II study of benmelstobart (PD-L1 inhibitor) plus anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) with high risk of recurrence after radical resection. (ASCO-GI 2025) - P2 | "The present study indicated that anlotinib plus benmelstobart as adjuvant treatment for HCC with high risk of recurrence after radical resection exhibited promising efficacy and tolerable safety profile. The conclusion should be validated in more participants included subsequently."

Clinical • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Preliminary results of benmelstobart plus anlotinib combined with SOX in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with low PD-L1 expression: A single-arm, multicenter phase II clinical trial. (ASCO-GI 2025) - P=N/A | "This study aims to evaluate the efficacy and safety of benmelstobart a PD-L1 blockade) in combination with anlotinib and SOX (S-1 plus oxaliplatin) as a first-line regimen for advanced G/GEJ adenocarcinoma in patients with low PD-L1 expression, Preliminary findings will be reported promptly... Preliminary findings indicate that the combination of benmelstobart and anlotinib with the SOX regimen as a first-line treatment for advanced G/GEJ adenocarcinoma with low PD-L1 expression demonstrates promising therapeutic efficacy and tolerable adverse events. Further validation of these results in a larger, consecutive patient population is warranted."

Clinical • IO biomarker • Metastases • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • PD-L1

Anlotinib plus benmelstobart as adjuvant therapy in patients with esophageal squamous cell carcinoma: A phase II clinical trial (ALTER-E005). (ASCO-GI 2025) - P1/2, P2 | "This study highlighted the promising efficacy and safety preliminarily of combining anlotinib with benmelstobart as adjuvant therapy in patients with ESCC who underwent radical (R0) resection and showed no recurrence 6 to 12 weeks after surgery."

Clinical • P2 data • Biliary Cancer • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology

Benmelstobart as consolidation therapy in patients with limited-stage small cell lung cancer : a single-arm open-label trial (ChiCTR) - P=N/A | N=30 | Sponsor: Anhui Provincial Cancer Hospital; Anhui Provincial Cancer Hospital

New trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Trial Evaluating TQB2102 for Injection in Combination With Benmelstobart/Penpulimab With or Without Capecitabine in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=168 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Neoadjuvant hypofractioned radiotherapy followed by benmelstobart plus chemotherapy for resectable non-small cell lung cancer: A phase II study (ChiCTR) - P1 | N=150 | Recruiting | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50) (clinicaltrials.gov) - P2 | N=47 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Neoadjuvant Therapy of Targeted Immunotherapy Combined With Chemotherapy for Locally Advanced HNSCC (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

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. | N=190 ➔ 270

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Prospective phase II study of Gemcitabine and Cisplatin combined with Anlotinib and Benmelstobart in the treatment of muscle invasive bladder cancer (ChiCTR) - P2 | N=61 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Cost-effectiveness analysis of benmelstobart, anlotinib, and chemotherapy in extensive-stage small-cell lung cancer. (PubMed, Front Immunol) - "The ETER701 trial assessed the efficacy and safety of benmelstobart combined with anlotinib plus etoposide/cisplatin (BEN-AL-EC) as a first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC). The key parameters influencing these outcomes included utility values for PFS, the cost of benmelstobart, and the discount rate. From the perspective of the Chinese healthcare system, BEN-AL-EC as a first-line treatment for ES-SCLC is unlikely to be cost-effective when compared with PLB-EC."

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

TQB2450 with or without anlotinib as maintenance treatment in subjects with locally advanced/unresectable non-small cell lung cancer that have not progressed after prior concurrent/sequential chemoradiotherapy (R-ALPS): study protocol for a randomized, double-blind, placebo-controlled, multicenter phase III trial. (PubMed, Transl Lung Cancer Res) - P3 | "Date of registration: May 27, 2020. Protocol version: Version 4.0, Sep 16, 2022 (https://classic.clinicaltrials.gov/ct2/show/NCT04325763)."

Clinical • IO biomarker • Journal • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

APPROVAL FOR MARKETING OF BENMELSTOBART INJECTION IN COMBINATION WITH ANLOTINIB HYDROCHLORIDE CAPSULE FOR THE INDICATION OF TREATMENT FOR ENDOMETRIAL CANCER (Sino Biopharm Press Release) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited...announces that Benmelstobart Injection...in combination with Anlotinib Hydrochloride Capsule has obtained approval for marketing from the National Medical Products Administration of China for use in treatment for patients with recurrent or metastatic endometrial cancer that is non-microsatellite instability-high (non-MSI-H) or non-mismatch repair-deficient (non-dMMR) who have failed prior systemic therapy but are not candidates for radical surgery or radiation....Some of the data from the Phase II study of Benmelstobart Injection in combination with Anlotinib Hydrochloride Capsule for the treatment of recurrent or metastatic endometrial cancer (ETER200/NCTO4574284) was presented at the 2024 International Gynecologic Cancer Society (IGCS) Annual Meeting."

China approval • Endometrial Cancer