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DRUG:

benmelstobart (APL-502)

i
Other names: APL-502, CBT 502, TQB2450, CBT-502, TQ-B2450, APL 502, APL502, CBT502, TQB 2450
Company:
Apollomics, JSR Life Sciences, Sino Biopharm
Drug class:
PD-L1 inhibitor
Related drugs:
4d
New P2 trial
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cisplatin • gemcitabine • Focus V (anlotinib) • benmelstobart (APL-502)
4d
New P1 trial
|
Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • benmelstobart (APL-502)
17d
New P2 trial • IO biomarker • Metastases
|
IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL17A (Interleukin 17A) • IFNA1 (Interferon Alpha 1) • IL1B (Interleukin 1, beta)
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5-fluorouracil • Focus V (anlotinib) • benmelstobart (APL-502) • Onivyde (nanoliposomal irinotecan)
20d
Anlotinib plus TQB2450, a PD-L1 Antibody, in Patients with Advanced Alveolar Soft Part Sarcoma: a single-arm, phase 2 trial. (PubMed, Clin Cancer Res)
The combination of anlotinib and TQB2450 is effective and tolerable in ASPS patients. TLS may serve as a prognostic biomarker, meriting further investigation.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
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Focus V (anlotinib) • benmelstobart (APL-502)
1m
TQB2450-III-07: A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer (clinicaltrials.gov)
P3, N=528, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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Focus V (anlotinib) • sunitinib • benmelstobart (APL-502)
1m
New P2 trial
|
carboplatin • paclitaxel • benmelstobart (APL-502)
1m
New P2 trial
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gemcitabine • Focus V (anlotinib) • albumin-bound paclitaxel • benmelstobart (APL-502)
2ms
TQB2450-II-11: A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=25, Completed, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting --> Completed | Trial completion date: Jun 2023 --> Apr 2024 | Trial primary completion date: Dec 2022 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date • Combination therapy
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benmelstobart (APL-502)
2ms
TQB2450-ALTN-II-02: Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=148, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Sep 2025 --> Dec 2027
Trial completion date • Trial primary completion date • IO biomarker • Metastases
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docetaxel • Focus V (anlotinib) • benmelstobart (APL-502)
2ms
New trial • Combination therapy
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albumin-bound paclitaxel • oxaliplatin • benmelstobart (APL-502)
4ms
Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma (clinicaltrials.gov)
P2, N=62, Recruiting, Shanghai Pulmonary Hospital, Shanghai, China
New P2 trial • IO biomarker
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benmelstobart (APL-502)
4ms
Anlotinib combined with TQB2450 and SOX in the first-line treatment of advanced gastric cancer: a single-arm, multicenter exploratory clinical study (ChiCTR2400085396)
P=N/A, N=37, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
New trial • Metastases
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PD-L1 (Programmed death ligand 1)
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Focus V (anlotinib) • oxaliplatin • benmelstobart (APL-502) • Teysuno (gimeracil/oteracil/tegafur)
4ms
New P2 trial • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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Focus V (anlotinib) • benmelstobart (APL-502)
4ms
TQB2450 Plus Anlotinib Combined With Chemotherapy in the Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
P=N/A, N=25, Active, not recruiting, Henan Cancer Hospital | Not yet recruiting --> Active, not recruiting | Phase classification: P2 --> PN/A | Trial completion date: Apr 2022 --> Dec 2024 | Trial primary completion date: Mar 2022 --> Dec 2024
Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Metastases
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Focus V (anlotinib) • capecitabine • oxaliplatin • benmelstobart (APL-502)
5ms
New P2 trial • Metastases
|
Focus V (anlotinib) • mitoxantrone • benmelstobart (APL-502) • Tomudex (raltitrexed)
5ms
New P3 trial
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paclitaxel • Focus V (anlotinib) • albumin-bound paclitaxel • benmelstobart (APL-502)
5ms
A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients (clinicaltrials.gov)
P3, N=322, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
New P3 trial
|
Focus V (anlotinib) • benmelstobart (APL-502)
6ms
P1 data • Journal • Metastases
|
MET (MET proto-oncogene, receptor tyrosine kinase) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • AXL (AXL Receptor Tyrosine Kinase) • KDR (Kinase insert domain receptor) • FLT1 (Fms-related tyrosine kinase 1) • FLT4 (Fms-related tyrosine kinase 4)
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benmelstobart (APL-502) • AL2846
10ms
New P2 trial
|
Focus V (anlotinib) • albumin-bound paclitaxel • benmelstobart (APL-502)
11ms
A single-arm, open-label, exploratory trial of radiotherapy in combination with TQB2450 and anlotinib hydrochloride in the treatment of relapsed metastatic HER2-negative breast cancer (ChiCTR2300072338)
P=N/A, N=30, Recruiting, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School; Nanjing Drum Tower Hospital, The Affiliated Hospital of Nan
New trial
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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ER positive • HER-2 negative • PGR positive
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Focus V (anlotinib) • benmelstobart (APL-502)
12ms
Predictive biomarkers of response and survival following immunotherapy with a PD-L1 inhibitor benmelstobart (TQB2450) and antiangiogenic therapy with a VEGFR inhibitor anlotinib for pretreated advanced triple negative breast cancer. (PubMed, Signal Transduct Target Ther)
Patients with both low MSAF and low bTMB showed a notably better objective response to anlotinib plus TQB2450 (70% vs. 11%, P < 0.001) and a significantly longer median PFS (11.0 vs. 2.9 months, P < 0.001) than patients with other scenarios. Our findings support future studes and validation of MSAF and the combined bTMB-MSAF classification as predictive biomarkers of immune checkpoint inhibitor-based regimens in advanced TNBC patients.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • KMT2C (Lysine Methyltransferase 2C)
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TP53 mutation • TMB-H • PIK3CA mutation • MLL mutation • MLL3 mutation
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Focus V (anlotinib) • benmelstobart (APL-502)
12ms
New P2 trial • IO biomarker • Metastases
|
docetaxel • Focus V (anlotinib) • benmelstobart (APL-502)
1year
A Clinical Trial of TQB2450 Injection Combined With AL2846 Capsules in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=135, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
New P1 trial • Metastases
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PD-L1 (Programmed death ligand 1)
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cisplatin • pemetrexed • benmelstobart (APL-502) • AL2846
1year
A randomized double-blind trial of TQB2450 with or without anlotinib in pretreated driver-negative non-small cell lung cancer. (PubMed, Lung Cancer)
Anlotinib plus TQB2450 demonstrated promising antitumor activities in advanced NSCLC patients without EGFR and ALK alterations and the toxicities were overall manageable. The study findings support the continued development of TQB2450 plus anlotinib for advanced NSCLC patients without driver gene alterations.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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EGFR wild-type
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Focus V (anlotinib) • benmelstobart (APL-502)
1year
Phase Ib study of anlotinib in combination with anti-PD-L1 antibody (TQB2450) in patients with advanced acral melanoma. (PubMed, J Eur Acad Dermatol Venereol)
TQB2450 combined with anlotinib showed favorable tolerance and promising anti-tumor activity with a prolonged PFS compared with anti-PD1 monotherapy in patients with advanced acral melanoma.
P1 data • Journal • Combination therapy • Metastases
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Focus V (anlotinib) • benmelstobart (APL-502)
over1year
Update results of anlotinib combined with TQB2450 (PD-L1 blockade) as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, multicenter, open-label phase II clinical trial (ESMO 2023)
The common grade ≥3 treatment-related adverse events in 46 patients were hypertension (7%), hyponatremia (4%), low white blood cell count (2%), neutrophil count decreased (2%), platelet count decreased (2%), intestinal obstruction (2%), haemoptysis (2%) and toothache (2%). Conclusions The preliminary results highlighted that anlotinib plus TQB2450 as a first-line therapy for advanced ESCC showed encouraging efficacy and manageable safety profile.
Clinical • P2 data • Metastases
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FLT1 (Fms-related tyrosine kinase 1)
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Focus V (anlotinib) • benmelstobart (APL-502)
over1year
A Phase I/II Study of TQ-B2450 plus Anlotinib in EGFR+ Advanced NSCLC Patients Failed to Prior EGFR TKI Therapies:Phase II Results Updates (IASLC-WCLC 2023)
However, the IMpower150 study subgroup analyses shows Atezolizumab (PD-L1) plus bevacizumab and chemotherapy improved overall survival in EGFR TKI treated NSCLC. The chemo-free combination of TQ-B2450 and anlotinib has shown incredible anti-tumor efficacy and well tolerance in the treatment of EGFR+ advanced NSCLC who failed to prior EGFR TKI therapies. Pts will be continuously monitored to determine longer-term outcomes.
Clinical • P1/2 data • P2 data • Metastases
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PD-L1 (Programmed death ligand 1)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
over1year
New P1 trial
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Focus V (anlotinib) • benmelstobart (APL-502)
over1year
New P3 trial • Metastases
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docetaxel • benmelstobart (APL-502) • AL2846
over1year
New P2 trial
|
PD-L1 (Programmed death ligand 1)
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Focus V (anlotinib) • benmelstobart (APL-502)
over1year
A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer. (PubMed, iScience)
No treatment-related deaths occurred. TQB2450 combined with anlotinib as a chemotherapy-free treatment shows promising efficacy with a manageable safety profile for patients with previously treated advanced TNBC.
P1 data • Journal • Metastases
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Focus V (anlotinib) • benmelstobart (APL-502)
over1year
Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma(ESCC) (clinicaltrials.gov)
P2, N=46, Active, not recruiting, The First Affiliated Hospital of Zhengzhou University | Not yet recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
Focus V (anlotinib) • benmelstobart (APL-502)
over1year
New P1/2 trial • Metastases
|
benmelstobart (APL-502) • TQB3728
almost2years
New P1/2 trial • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
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PD-L1 expression • ALK fusion • ALK mutation • ROS1 fusion • ROS1 mutation
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benmelstobart (APL-502) • TQB2618
2years
New P1/2 trial • IO biomarker
|
PD-L1 IHC 22C3 pharmDx
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Focus V (anlotinib) • capecitabine • oxaliplatin • benmelstobart (APL-502) • osemitamab (TST001) • fidasimtamab (IBI315)
over2years
Phase Ib study of anlotinib combined with TQB2450 in pretreated advanced biliary tract cancer and biomarker analysis. (PubMed, Hepatology)
Anlotinib combined with TQB2450 showed promising efficacy and was well tolerated in advanced BTCs. KRAS mutation and high TMB might serve as predictors of treatment efficacy.
P1 data • Journal • Tumor Mutational Burden • PD(L)-1 Biomarker • IO biomarker
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KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden)
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KRAS mutation • TMB-H
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Focus V (anlotinib) • benmelstobart (APL-502)
over2years
New P3 trial
|
ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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ALK fusion • ROS1 fusion • ALK-ROS1 fusion
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carboplatin • Focus V (anlotinib) • Tevimbra (tislelizumab-jsgr) • pemetrexed • benmelstobart (APL-502)
almost3years
Clinical • Enrollment open
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MUC16 (Mucin 16, Cell Surface Associated)
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paclitaxel • Focus V (anlotinib) • benmelstobart (APL-502)
almost3years
Clinical • New P3 trial
|
MUC16 (Mucin 16, Cell Surface Associated)
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paclitaxel • Focus V (anlotinib) • benmelstobart (APL-502)
almost3years
New P1/2 trial
|
PD-L1 (Programmed death ligand 1)
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benmelstobart (APL-502) • culmerciclib (TQB3616)
3years
Clinical • Enrollment open
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
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Keytruda (pembrolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)
over3years
Clinical • New P3 trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK fusion
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Keytruda (pembrolizumab) • Focus V (anlotinib) • benmelstobart (APL-502)