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

Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases (clinicaltrials.gov) - P2 | N=366 | Not yet recruiting | Sponsor: Xinqiao Hospital of Chongqing

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

UPLIFT: Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations (clinicaltrials.gov) - P3 | N=270 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangzhou Medical University

IO biomarker • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Endometrial Cancer • Oncology • Solid Tumor

Benmelstobart Combined With Radiochemotherapy as Neoadjuvant Treatment Iin ESCC (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Shanghai Zhongshan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Benmelstobart plus carboplatin/paclitaxel with or without anlotinib, followed by maintenance benmelstobart with or without anlotinib, as first-line treatment for advanced or recurrent endometrial cancer: A randomized, open-label, phase II trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05481645 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Endometrial Cancer • Oncology • Solid Tumor

Updated results of anlotinib plus benmelstobart combined with nab-paclitaxel and cisplatin as first-line treatment for advanced biliary tract cancer: A single-arm, open-label phase II clinical trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05812430 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

ETER901: A randomized, open-label, phase III trial of anlotinib in combination with anti-PD-L1 antibody benmelstobart (TQB2450) versus nab-paclitaxel in first-line treatment of recurrent or metastatic triple-negative breast cancer. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04405505 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Chemotherapy: Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: Jiangsu Cancer Institute & Hospital | N=56 ➔ 26 | Initiation date: Mar 2025 ➔ Jun 2025

Enrollment change • Trial initiation date • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor

ALTER-PA001: A multicenter, randomized study of anlotinib and benmelstobart in combination with AG chemotherapy vs. AG as first-line treatment for metastatic pancreatic cancer. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06621095 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

FAITH trial: Feasibility and safety of anlotinib plus benmelstobart in patients with previously immunotherapy treated intermediate-to-advanced hepatocellular carcinoma—Amulticenter, single arm, prospective phase Ⅱ trial. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT06031480 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Hepatocellular Cancer • Oncology • Solid Tumor

Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC). (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT05718167 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04964479 The abstract will be released to the public on June 1, 2025 at 7:00 AM CDT"

Clinical • Combination therapy • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04325763 The abstract will be released to the public on June 2, 2025 at 7:00 AM CDT"

Clinical • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma: Subgroup analysis from the phase 3 ETER100 trial. (ASCO 2025) - P3 | "Clinical Trial Registration Number: NCT04523272 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Anlotinib Combined With Benmelstobart for Advanced Pheochromocytoma (clinicaltrials.gov) - P2 | N=22 | Not yet recruiting | Sponsor: Sun Yat-sen University | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: May 2024 ➔ May 2027

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Endocrine Cancer • Oncology • Solid Tumor • PD-L1

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 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression (clinicaltrials.gov) - P2 | N=37 | Recruiting | Sponsor: Yongxu Jia

IO biomarker • New P2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • PD-L1

A Real-world Study of Benmelstobart, Anlotinib and Chemotherapy Regimen as First-line Treatment for Extensive-stage Small-cell Lung Cancer (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P4 trial • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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

TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Fudan University

Checkpoint inhibition • dMMR • New P2 trial • Tumor mutational burden • Endometrial Cancer • Oncology • Solid Tumor

Combination treatment of TLR7 agonist and anti-PD-L1 reconstitute protective immunity in virally suppressed chronic hepatitis B patients (EASL 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 favouring improved clinical outcome."

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

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