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

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

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

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

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

Circulating Tumor DNA Guided Boost Therapy in Early Triple Negative Breast Patients With Residual Disease After Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=411 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Circulating tumor DNA • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

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

This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Tang-Du Hospital

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

Benmelstobart plus anlotinib and chemotherapy in HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma: A phase 2 study. (PubMed, Cell Rep Med) - P=N/A | "This study shows promising efficacy and safety, representing a potential first-line option in patients with HER2-negative advanced G/GEJ cancer, regardless of PD-L1 expressions. The study was registered at ClinicalTrials.gov (NCT04891900)."

IO biomarker • Journal • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CD8 • HER-2 • PD-L1

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

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

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