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DRUG:

Andewei (benmelstobart)

i
Other names: APL-502, CBT 502, TQB2450, CBT-502, TQ-B2450, APL 502, APL502, CBT502, TQB 2450
Company:
Apollomics, Sino Biopharm
Drug class:
PD-L1 inhibitor
Related drugs:
1d
New P2 trial
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Focus V (anlotinib) • cyclophosphamide • Andewei (benmelstobart)
13d
Benmelstobart plus anlotinib versus pembrolizumab as first-line treatment for PD-L1-positive, advanced non-small-cell lung cancer (CAMPASS): a blinded, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
Benmelstobart plus anlotinib showed longer progression-free survival than pembrolizumab plus placebo and no unexpected safety signals were reported, suggesting benmelstobart plus anlotinib as a potential first-line option in driver gene-negative, PD-L1-positive, advanced NSCLC. Longer term follow-up is needed to establish effects on overall survival.
P3 data • Journal
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression • PD-L1 negative
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Keytruda (pembrolizumab) • Focus V (anlotinib) • Andewei (benmelstobart)
22d
New P3 trial
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TP53 (Tumor protein P53) • FAT1 (FAT atypical cadherin 1) • NOTCH3 (Notch Receptor 3)
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TP53 mutation
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cisplatin • paclitaxel • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Andewei (benmelstobart)
27d
Anlotinib and Benmelstobart in DTC (clinicaltrials.gov)
P2, N=23, Not yet recruiting, Fudan University | Initiation date: Oct 2025 --> Apr 2026
Trial initiation date
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Focus V (anlotinib) • Andewei (benmelstobart)
2ms
Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients (clinicaltrials.gov)
P2, N=56, Recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting --> Recruiting
Enrollment open
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5-fluorouracil • Focus V (anlotinib) • Andewei (benmelstobart) • Onivyde (nanoliposomal irinotecan)
2ms
New P3 trial
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cisplatin • gemcitabine • Focus V (anlotinib) • Andewei (benmelstobart)
2ms
Efficacy and Safety of Anlotinib plus Benmelstobart In Unresectable Anaplastic Thyroid Cancer: A Multicenter, Phase II, Single-arm Trial (ABATC Trial) (ChiCTR2500111580)
P2, N=60, Not yet recruiting, The First Affiliated Hospital, Sun Yat-sen University; The First Affiliated Hospital, Sun Yat-sen University
New P2 trial
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Focus V (anlotinib) • Andewei (benmelstobart)
2ms
New P1/2 trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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EGFR mutation • MSI-H/dMMR • BRAF mutation • NRAS mutation • RAS mutation • RET mutation • MET mutation
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Lynparza (olaparib) • topotecan • Andewei (benmelstobart)
3ms
TQB2450-II-14: Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus. (clinicaltrials.gov)
P2, N=71, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Trial completion date: Dec 2024 --> Nov 2025 | Recruiting --> Terminated; Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
Trial completion date • Trial termination • IO biomarker
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carboplatin • gemcitabine • paclitaxel • docetaxel • Focus V (anlotinib) • doxorubicin hydrochloride • Andewei (benmelstobart)
3ms
Serum BDNF helps identify favorable subgroups in HCC patients treated with PD-L1 inhibitors and anti-angiogenic TKIs. (PubMed, Ther Adv Med Oncol)
We aimed to assess the efficacy, safety, and potential biomarkers of anlotinib plus TQB2450 in patients with advanced HCC. Elevated serum BDNF levels might serve as a potential positive prognostic marker and, together with ECOG score, may help complement the CRAFITY score in identifying subgroups that could benefit from ICIs and antiangiogenic therapy. This study was registered on ClinicalTrials.gov (NCT03825705, registered January 31, 2019).
Journal • PD(L)-1 Biomarker • IO biomarker
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AFP (Alpha-fetoprotein) • BDNF (Brain Derived Neurotrophic Factor) • CRP (C-reactive protein)
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Focus V (anlotinib) • Andewei (benmelstobart)
3ms
New P2 trial
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KRAS (KRAS proto-oncogene GTPase)
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Erbitux (cetuximab) • Focus V (anlotinib) • Andewei (benmelstobart) • Anfangning (garsorasib)
4ms
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, 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
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Andewei (benmelstobart) • TQB2102