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

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

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Anlotinib plus Benmelstobart (TQB2450) as a first-line treatment for advanced NSCLC who are not suitable for platinum-containing dual chemotherapy: a Phase II, single-arm, multicenter clinical study (ChiCTR) - P2 | N=42 | Recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

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

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

Phase II Clinical Trial of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma (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

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) - No abstract available

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

TQB2450 plus intensity-modulated radiotherapy in recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial (ESMO 2025) - No abstract available

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

The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Shandong First Medical University

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

TQB2102-II-04: A Clinical Trial Evaluating TQB2102 for Injection in Combination With Behmosubaisumab/Payamprolizumab With or Without Chemotherapy in Unresectable Locally Advanced, Recurrent, or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Gastroesophageal Adenocarcinoma (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Cost-effectiveness of benmelstobart-anlotinib-chemotherapy in extensive-stage small-cell lung cancer: A comparative analysis across United States and Chinese healthcare systems. (PubMed, Int J Clin Pharm) - "Benmelstobart plus anlotinib and EC group is likely to be cost-effective in the US at a WTP threshold of $150,000/QALY, but not in China at current prices. An 80% price reduction in China would be necessary to align with its WTP threshold, emphasizing the need for policy interventions in drug pricing and reimbursement to improve patient access."

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

Adjuvant HAIC combined with anlotinib and TQB2450 for resected high-risk hepatocellular carcinoma. (PubMed, Innovation (Camb)) - "Postoperative adjuvant HAIC combined with anlotinib and TQB2450 demonstrated encouraging clinical benefits in reducing recurrence with manageable toxicities in patients at high risk of HCC recurrence. 4-cycle anlotinib combined with HAIC and TQB2450 is recommended as an adjuvant treatment for further investigation."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

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 | Recruiting | Sponsor: Xinqiao Hospital of Chongqing | Not yet recruiting ➔ Recruiting

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

Anlotinib combined with benmelstobart as a chemo-free first-line treatment in advanced esophageal squamous cell carcinoma: an exploratory multicenter, single-arm phase II clinical trial. (PubMed, Mol Cancer) - P2 | "First-line anlotinib-benmelstobart combination demonstrated durable responses and acceptable safety in ESCC patients. Exploratory biomarker analyses identified a TP53+/FAT1+/NOTCH3- mutational signature potentially associated with improved outcomes, though further validation in randomized trials is warranted."

Biomarker • IO biomarker • Journal • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma • FAT1 • NOTCH3 • TP53

A single-arm, multicenter, exploratory clinical study of anlotinib hydrochloride combined with TQB2450 (PD-L1 inhibitor) in the treatment of advanced esophageal squamous cell carcinoma (ChiCTR) - P2 | N=24 | Not yet recruiting | Sponsor: Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University); Zhenjiang First People's Hospital (Affiliated People’s Hos

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

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 | "While AG chemotherapy (nab-paclitaxel and gemcitabine) is a current standard first-line regimen, new combinations are needed to improve outcomes. Exploratory biomarker analyses will assess correlations between baseline tumor characteristics and therapeutic outcomes. This trial is actively recruiting in November 2024."

Clinical • Combination therapy • IO biomarker • Metastases • 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) - P1/2, P2 | "Anlotinib combined with benmelstobart demonstrated potential efficacy and acceptable safety profile in patients with intermediate-to-advanced HCC who failed prior ICI therapies, which is worthy of further exploration with continuous recruitment of the study subsequently."

Clinical • Metastases • Hepatocellular Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

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 | "Preliminary results suggested that anlotinib plus benmelstobart combined with nab-paclitaxel and cisplatin as first-line therapy in advanced BTC exhibited encouraging efficacy and manageable adverse events. The conclusion should be validated in more patients subsequently."

Clinical • IO biomarker • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Hypotension • Leukopenia • Mucositis • Oncology • Pain • Solid Tumor • Stomatitis • FLT1

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 | "The combination of benmelstobart plus ALNT might extend both progression-free survival and overall survival in the first-line treatment of patients with recurrent or metastatic TNBC. The adverse events were in line with the previously established safety profiles of each individual agent. (Funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd."

Clinical • Combination therapy • Metastases • P3 data • Breast Cancer • Dyslipidemia • Hypertension • Hypertriglyceridemia • Infectious Disease • Oncology • Solid Tumor • Triple Negative Breast Cancer

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 | "Benmelstobart combined with carboplatin/paclitaxel and anlotinib, followed by maintenance benmelstobart and anlotinib, demonstrated clinically meaningful ORR and PFS benefits in patients with previously untreated advanced or recurrent EC. The regimen was particularly helpful in improving outcomes for patients with pMMR tumors, potentially providing a new treatment option."

Clinical • Metastases • P2 data • Anemia • Endometrial Cancer • Oncology • Solid Tumor • Thrombocytopenia • PD-L1

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 | "TQB2450-III-12 is a multicenter, randomized, double-blind, parallel-controlled phase III study of benmelstobart (PD-L1 inhibitor) in combination with chemotherapy followed by sequential combination with anlotinib (multi-targeted angiogenesis inhibitor) versus tislelizumab plus chemotherapy as first-line therapy for locally advanced or metastatic sq-NSCLC...Paclitaxel (175 mg/m2, day 1) and carboplatin (area under the concentration [AUC] of 5, day 1) were given every 3 weeks... Benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib significantly improved PFS, with a manageable safety profile. It might be a new first-line treatment for sq-NSCLC."

Clinical • Combination therapy • IO biomarker • 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 | "To our knowledge, this is the first phase III study to demonstrate the significant PFS benefit of a multikinase inhibitor plus an anti-PD-L1 mAb in the first-line treatment of PD-L1-positive aNSCLC compared to pembrolizumab. Tolerability is favourable with a lower incidence of treatment discontinuation due to TRAE. The data support this combination as a new option for these pts."

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

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 | "Benmelstobart, both as monotherapy and in combination with anlotinib, significantly prolonged PFS compared to placebo. Secondary endpoints also showed superiority, and the safety profile of the treatment group remained within acceptable parameters. (Funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; ClinicalTrials.gov number, NCT04325763)."

Clinical • Late-breaking abstract • Metastases • P3 data • Cardiovascular • Dyslipidemia • Hypertension • Hypertriglyceridemia • 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 | "The RCC pts with a poor prognosis such as intermediate-poor IMDC risk, liver metastasis and bone metastasis could significantly benefit from benmelstobart plus anlotinib."

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

Benmelstobart With/Without Anlotinib Is Effective Consolidation Therapy in NSCLC (Cancer Network) - P3 | N=315 | R-ALPS (NCT04325763) | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd | "Benmelstobart (TQB2450), both alone and in combination with anlotinib, demonstrated significant progression-free survival (PFS) benefits as consolidation therapy vs placebo for patients with unresectable stage III non–small cell lung cancer (NSCLC) who did not progress following chemoradiotherapy, while maintaining a manageable safety profile...At the November 2023 data cutoff, the median PFS assessed by independent review was 15.1 months for the combination therapy (95% CI, 9.4-21.7), compared with 9.7 months with benmelstobart alone (95% CI, 6.0-34.4) and 4.2 months with placebo (95% CI, 3.2-6.8). Both active treatment arms demonstrated highly significant improvements vs placebo (HR 0.49 and 0.53, respectively; P <.0001)."

P3 data • Non Small Cell Lung Cancer

TQB2450-II-08: A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer (clinicaltrials.gov) - P2 | N=170 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion • Endometrial Cancer • Oncology • Solid Tumor