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Last update 25 Mar 2025

Benmelstobart

Last update 25 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-PD-L1 monoclonal antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), PD-L1 antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group), APL 502

+ [7]

Target

PDL1

Action

inhibitors, stimulants

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors), T lymphocytes stimulants

Therapeutic Areas

NeoplasmsRespiratory DiseasesUrogenital Diseases+ [8]

Active Indication

Endometrial CarcinomaExtensive stage Small Cell Lung CancerAdvanced Lung Non-Small Cell Squamous Carcinoma+ [36]

Inactive Indication

Acral Lentiginous Malignant Melanomaadenocarcinoma of biliary tractAdvanced Bile Duct Carcinoma+ [16]

Originator Organization

Zhejiang Crownmab Biotech Co. Ltd.

Active Organization

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Sino Biopharmaceutical Ltd.

Nanjing Shunxin Pharmaceutical Co., Ltd.

+ [1]

Inactive Organization

Zhejiang Crownmab Biotech Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

China (30 Apr 2024),

Extensive stage Small Cell Lung Cancer

RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 10067450H

Source: *****

Sequence Code 10067454L

Source: *****

105

Clinical Trials associated with Benmelstobart

NCT06851169

/ Not yet recruitingPhase 2IIT

A Two-cohort, Exploratory Clinical Study of Perioperative Benmelstobart Alone or Combined with Anlotinib in Patients with Resectable PD-L1≥50% Non-small Cell Lung Cancer

A total of 58 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 29 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 12 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week. Cohort 2: Neoadjuvant therapy (benmelstobart only, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Adjuvant therapy (benmelstobart, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.

Start Date01 Apr 2025

Sponsor / Collaborator

Tangdu Hospital

NCT06848439

/ Not yet recruitingPhase 2IIT

A Phase II Study of Benmelstobart Combined with Anlotinib and Chemotherapy As Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer

Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 45Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50-55Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).

Start Date15 Mar 2025

Sponsor / Collaborator

Jiangsu Cancer Hospital

NCT06767800

/ Not yet recruitingPhase 2

Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection in Chemotherapy With Behmosubstituted Monoclonalb/Pembrolizumab ± Capecitabine in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma

TQB2102 for injection is a novel antibody-coupled drug (ADC) that enhances binding to tumor cell surface HER2 proteins by simultaneously targeting the two non-overlapping epitopes of the HER2 protein, Endothelial Cell Dysfunction 2 (ECD2) and Endothelial Cell Dysfunction 4 (ECD4), increasing HER2 internalization, and then down-regulating the tumor cell surface HER2 proteins more effectively, and doubly blocking the HER2 signaling, to achieve the effects of trastuzumab and Pertuzumab alone and in combination. This is a Phase II study to evaluate the efficacy and safety of TQB2102 for injection in combination with Benmelstobart Injection /Penpulimab Injection ± capecitabine in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma

Start Date01 Feb 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Benmelstobart

100 Translational Medicine associated with Benmelstobart

100 Patents (Medical) associated with Benmelstobart

276

Literatures (Medical) associated with Benmelstobart

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HMGB1 assists the predictive value of tumor PD-L1 expression for the efficacy of anti-PD-1/PD-L1 antibody in NSCLC

Article

Author: Oga, Toru ; Masuda, Takeshi ; Horimasu, Yasushi ; Hattori, Noboru ; Yamaguchi, Kakuhiro ; Hamada, Hironobu ; Funaishi, Kunihiko ; Iwamoto, Hiroshi ; Tanahashi, Hiroki ; Oka, Mikio ; Nakashima, Taku ; Sakamoto, Shinjiro ; Kurose, Koji

Abstract:

Background:

The expression of anti-programmed cell death ligand-1 (PD-L1) in tumors is widely used as a biomarker to predict the therapeutic efficacy of anti-programmed cell death-1(PD-1)/PD-L1 antibodies. However, the predictive accuracy of this method is limited. High-mobility group box 1 (HMGB1) is known to modulate cancer immunity. Therefore, we investigated the potential of circulatory HMGB1 in combination with PD-L1 expression to predict the efficacy of anti-PD-1/PD-L1 antibody monotherapy.

Patients and methods:

This multicenter retrospective study analyzed blood samples collected from 114 patients with non-small cell lung cancer (NSCLC) prior to anti-PD-1/PD-L1 antibody monotherapy at two university hospitals (Hiroshima University Hospital and Kawasaki Medical School Hospital) between December 2015 and October 2020. We evaluated the association of serum HMGB1 levels with tumor response and progression-free survival (PFS).

Results:

Serum HMGB1 levels were significantly higher in patients with complete or partial response than in those with stable or progressive disease. Using receiver operating characteristic analysis, the cut-off level of serum HMGB1 to predict tumor response was determined to be 3.83 ng/mL. PFS was significantly longer in the HMGB1high group than that in the HMGB1low group in the entire cohort (4.3 months vs. 2.3 months) and in patients with NSCLC with PD-L1 tumor proportion score (TPS) ≥ 50% (12.4 months vs. 4.4 months), but not in those with PD-L1 TPS < 50% or unknown.

Conclusion:

HMGB1 may serve as a predictive biomarker for the efficacy of anti-PD-1/PD-L1 antibody therapy in the patients with NSCLC, especially in those with PD-L1 TPS ≥ 50%.

01 Apr 2025·Materials Today Bio

Improving ferroptosis-mediated immunotherapy for colorectal cancer through lysosome-targeted photodynamic therapy

Article

Author: Zhang, Qianbing ; Lu, Chuyue ; Lin, Zhenyu ; Wang, Yutong ; Zheng, Hua ; Li, Zhenhao ; Chen, Lujia ; Chen, Zhian ; Chen, Meijuan ; Li, Yingshi

Lysosomes is emerging as a promising therapeutic target for improving immunotherapy, which dysfunction would trigger lysosomal membrane permeabilization increase and subsequent leakage of reduced iron, which contributed to ferroptosis through cell-intrinsic Fenton chemistry. However, the integrity of lysosomal membranes is not susceptible to disrupt, owing to the presence of several Endo-lysosomal damage-response mechanisms. Herein, we developed a lysosome-targeted photosensitizer (TLA), which possessed robust light stability, good bio-compatibility, and high photodynamic therapy (PDT) effect. Upon internalized by cancer cells, TLA was specifically accumulated in lysosome, and which would destroy the integrity of lysosomal membranes and inhibit protective autophagy upon exposure to light irradiation. Subsequently, the cancer cells were suffered from ferroptosis through triggering cell-intrinsic Fenton chemistry and mitochondrial dysfunction, which would release damage-associated molecular pattern molecules (DAMPs) to induce immunogenic cell death and remodel immunosuppressive tumor microenvironment. Notably, combined with PD-L1 antibody and TLA could greatly potentiate the immune response and exhibit highest anti-tumor effects. In summary, this novel lysosome-targeted photosensitizer could serve as a promising strategy for the treatment of colorectal cancer.

01 Apr 2025·HEPATOLOGY

A randomized phase 2b study of subcutaneous PD-L1 antibody ASC22 in virally suppressed patients with chronic hepatitis B who are HBeAg-negative

Article

Author: Xie, Qing ; Yang, Yongfeng ; Fu, Lei ; Wu, Jinzi J. ; Mao, Qianguo ; Chen, Yongping ; Cui, Yimin ; Xie, Yao ; Qian, Jiandan ; Zhang, Qin ; Guo, Xiaolin ; Wang, Guiqiang ; Chen, Xinyue ; Lu, Jiajie ; Hou, Jinlin ; Gu, Ye ; Hu, Guoxin ; Yan, Yuemei ; Zou, Guizhou

Background and Aims::

Studies have shown that blocking the programmed cell death-1/programmed cell death ligand 1 pathway may lead to a potential cure for HBV infections. ASC22 (envafolimab) is a humanized, single-domain programmed cell death ligand 1 antibody administered subcutaneously. This study aimed to evaluate the efficacy and safety of ASC22 in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs.

Approach and Results::

This randomized, single-blind, phase IIb trial enrolled patients with chronic hepatitis B in 2 cohorts for a 24-week treatment with ASC22 or placebo (PBO) once every 2 weeks and 24-week follow-up. In total, 60, 59, and 30 patients were treated with 1.0, 2.5 mg/kg ASC22, and PBO, respectively. The mean changes in HBsAg from baseline at weeks 24 and 48 were −0.309 (p < 0.001) and −0.272 (p < 0.023) log10 IU/mL in the 1.0 mg/kg ASC22 group, −0.231 (p = 0.007) and −0.205 (p = 0.12) log10 IU/mL in the 2.5 mg/kg ASC22 group, and −0.003 and −0.063 log10 IU/mL in the PBO group, respectively (intent-to-treat population). Three out of 10 patients with baseline HBsAg levels ≤100 IU/mL in the 1.0 mg/kg group obtained on-treatment HBsAg loss. Most adverse events were mild (97.9%). There were no study drug–related serious adverse events in the 1.0 mg/kg ASC22 group.

Conclusions::

Subcutaneous administration of 1.0 mg/kg ASC22 once every 2 weeks for 24 weeks was shown to be safe and well-tolerated in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs and can induce HBsAg decline, especially in patients with HBsAg ≤100 IU/mL.

News (Medical) associated with Benmelstobart

24 Mar 2025

·www.prnewswire.com

CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer

SUZHOU, China, March 23, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab. The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This marks CStone's second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer. The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated: 36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS). 56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit. Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential). Favorable safety profile, no new safety signals identified. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented: "Following sugemalimab's approval in Europe for stage IV NSCLC, we are working closely with EMA to expand its indications in earlier stage lung cancer and other malignancies. With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for stage III NSCLC patients. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide." About Sugemalimab The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications: In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC; For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5. About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . IR contact: [email protected] PR contact: [email protected] Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalImmunotherapyClinical ResultADC

27 Dec 2023

·synapse.patsnap.com

TQB2450: A Quick Look at Its R&D Progress and Clinical Results from the 2023 ESMO_ASIA

On 2 Dec 2023, the latest clinical trial about TQB2450 for the treatment for patients with hepatocellular carcinoma at high risk of recurrence was presented in 2023 ESMO_ASIA. TQB2450's R&D ProgressTQB2450, also called Benmelstobart, is a monoclonal antibody drug that targets PDL1. It has a wide range of therapeutic areas, including neoplasms, infectious diseases, digestive system disorders, endocrinology and metabolic disease, urogenital diseases, respiratory diseases, immune system diseases, hemic and lymphatic diseases, mouth and tooth diseases, skin and musculoskeletal diseases, and otorhinolaryngologic diseases. According to the Patsnap Synapse, TQB2450 has reached the highest phase of development, NDA/BLA globally. And the clinical trial distributions for TQB2450 are primarily in China. The key indication is Advanced Lung Non-Small Cell Carcinoma. Detailed Clinical Result of TQB2450This single group assignment, open-labeled clinical trial (NCT04888546) was designed to evaluate the efficacy and safety of TQB2450 plus anlotinib as a perioperative regimen for the treatment of resectable HCC with a high risk of recurrence. In this study, pts with primary resectable HCC who were at high risk of recurrence were enrolled. High-risk features include tumor size >5 cm, multiple tumors (≤ 3), satellite nodules, and macrovascular invasion (MVI). Before surgery, pts received 3 cycles of TQB2450 (1200 mg, IV, d1, Q3W) plus 2 cycles of anlotinib (10 mg, PO, d1-d14, Q3W). The feasibility of resection was assessed by radiographic imaging. After 30 days of surgery, patients continued combination therapy for 24 weeks. The primary endpoints were pCR and ORR (mRECIST). Secondary endpoints were PFS, OS, and safety. CRAFITY was derived from serum CRP and AFP values at baseline by adding one point each for CRP ≥1 mg/dL and AFP ≥100 ng/mL resulting in three categories: CRAFITY-low, 0 points; CRAFITY-intermediate, 1 point; CRAFITY-high, 2 points. The result showed that as of July 15, 2023, 20 pts were enrolled (median age 61y [31-68], 95% male), 80% had HBV infection. All pts had Child-Pugh class A and ECOG PS 0. 11 (55%) had single (>5 cm) and 9 (45%) had multiple tumors. While n=10 (50%), n=8 (40%), and n=2 (10%) had CRAFITY-low, intermediate and high, respectively. Of 17 evaluable pts, ORR was 29.4% (5/17), 2 PR pts had low and 3 had intermediate CRAFITY scores. 13 pts completed preoperative therapy and underwent hepatic resection, the R0 resection rate was 100% and the pCR rate was 23.1% (3/13). Among the 3 pCR pts, 1 had low and 2 had intermediate CRAFITY scores; 2 had multiple tumors and no pts had MVI. 13 pts had TRAEs and grade 3/4 TRAEs (10%) including one hypertension (grade 3) and one liver damage (grade 4). It can be concluded that neoadjuvant therapy combining TQB2450 and anlotinib shows promising results, with a tolerable safety profile. The predictive role of the CRAFITY score for HCC prognosis is worth further exploration. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. If you would like to view more information about this result, you can go to the result detail page by clicking on the title. Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

05 Dec 2023

·synapse.patsnap.com

An analysis of Benmelstobart's R&D progress and its clinical results presented at the 2023 AACR Annual Meeting

On 15 Apr 2023, the updated PFS & OS from the interim analysis (data cutoff Oct 14, 2021) of the study (NCT03910127) was reported at the AACR Congress, illustrating its potential clinical benefits and setting the stage for further exploration. Benmelstobart's R&D ProgressBenmelstobart is a monoclonal antibody drug that targets PDL1. It has a wide range of therapeutic areas, including neoplasms, infectious diseases, digestive system disorders, endocrinology and metabolic disease, urogenital diseases, respiratory diseases, immune system diseases, hemic and lymphatic diseases, mouth and tooth diseases, skin and musculoskeletal diseases, and otorhinolaryngologic diseases. According to the Patsnap Synapse, Benmelstobart has reached the highest phase of development, NDA/BLA globally. And the clinical trial areas for Benmelstobart are primarily in the China. The key indication is Advanced Lung Non-Small Cell Carcinoma. Detailed Clinical Result of BenmelstobartThe randomized, parallel assignment, quadruple masking clinical trial (NCT03910127) was aimed to evaluate the efficacy and safety of TQB2450 alone/with Anlotinib in previously treated advanced non-small cell lung cancer. In this study, adult patients with histologically or cytologically-confirmed stage IIIB or IV NSCLC who had wild-type EGFR/ALK and at least one line of prior systemic therapy or being intolerable of chemotherapy were randomized 1:1:1 to receive TQB2450 1200 mg plus placebo, or anlotinib 10 or 12 mg. The primary end point was PFS and secondary endpoints included safety and OS. The result showed that Between July. 2019 and March. 2021, 101 pts were enrolled. 33 patients were randomly assigned to TQB2450 plus placebo and 68 patients to TQB2450 plus anlotinib. As of 19 September 2022, The median follow-up was 26.3 months. The median PFS (7.3 months, 95% CI 5.3-11.0) for TQB2450 plus anlotinib was significantly longer than that for TQB2450 plus placebo group (2.8 months, 95% CI 1.4-4.7) (HR 0.39, 95% CI 0.23-0.64; P=0.0001). In patients with PD-L1 ≥ 1%, the mPFS was 17.9 months (95% CI 5.8-31.1) in TQB2450 plus anlotinib 12 mg, which was numerically higher than that in TQB2450 plus anlotinib 10 mg. The median OS of patients with PD-L1 ≥ 1% for TQB2450 plus anlotinib 12 mg was numerically higher than that in TQB2450 plus anlotinib 10 mg (32.2 months vs 21.8 months). Grade 3 or higher TRAEs occurred in 50.0% of the patients in TQB2450 plus anlotinb and in 12.1% of those in TQB2450 plus placebo. It can be concluded that in this updated analysis with longer follow-up, TQB2450 combined with anlotinib continues to demonstrate overall efficacy and manageable safety profiles in chemotherapy treated patients with advanced NSCLC without driver gene mutations. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. If you would like to view more information about this result, you can go to the result detail page by clicking on the title. Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Benmelstobart

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Endometrial Carcinoma	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	22 Nov 2024
Extensive stage Small Cell Lung Cancer	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	30 Apr 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Squamous Carcinoma	NDA/BLA	China	Sino Biopharmaceutical Ltd.	27 Dec 2024
Metastatic Renal Cell Carcinoma	NDA/BLA	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	01 Aug 2024
Unresectable Renal Cell Carcinoma	NDA/BLA	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	01 Aug 2024
Squamous non-small cell lung cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	18 Jan 2023
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Sep 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Non-Small Cell Lung Cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Non-squamous non-small cell lung cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	21 Jul 2021
Advanced biliary tract cancer	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	26 Jan 2021
Kidney Neoplasms	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	25 Aug 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05252078 (ALTER-E005, ASCO_GI2025) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Adjuvant	30	Anlotinib + Benmelstobart	vqzdwqxdrb(qttqmramdq) = not reached xzqqzvdkvu (zxvxqzgvqy ) View more	Positive	23 Jan 2025
NCT04325763 (TQB2450-Ⅲ-05, NEWS) Manual	Phase 3	Non-Small Cell Lung Cancer Consolidation	-	贝莫苏拜单抗	cenjlyecuc(sdflzjluze) = rsajvjkkbk arcdgpiywr (mefuvmyure )	Positive	19 Dec 2024
				贝莫苏拜单抗 + 安罗替尼	-
NCT04574284 (TQB2450-II-08, IGCS2024 \| NEWS) Manual	Phase 2	Endometrial Carcinoma non-MSI-H/dMMR	85	Benmelstobart+anlotinib (stage 2 of cohort 1)	ykkquebifo(ldvbymmpht) = hibbivfwtr nzwktsdrlt (uexnurbqva ) View more	Positive	05 Nov 2024
NCT05111366 (ALTER-H006, ESMO2024) Manual	Phase 2	Hepatocellular Carcinoma Adjuvant	38	AnlotinibTQB2450	xhcylzvtdq(tbgoyqwkyu) = kzgdcnxyin juotcwyjuv (gecpjtkegb, 28.61 - 72.50) View more	Positive	16 Sep 2024
NCT04523272 (ETER100, ESMO2024) Manual	Phase 3	Advanced Renal Cell Carcinoma First line	531	Benmelstobart (BMSB) + Anlotinib (ALTN)	kxxknporte(bzliepcouu) = zeiqpvobfb kfrpevoxcl (fxxtokobhl ) View more	Positive	15 Sep 2024
				Sunitinib	kxxknporte(bzliepcouu) = dttplssskq kfrpevoxcl (fxxtokobhl ) View more
ESMO2024	Not Applicable	ER-low Breast cancer	-	PD-L1 (ER-low (ER=1-9%/HER2-))	ughrrdyoev(bswiaotsbb) = rwtngzxthn bagcuirbnu (vwczjvixee )	-	15 Sep 2024
				PD-L1 (Triple-negative (TN) (ER=0%/HER2-))	ughrrdyoev(bswiaotsbb) = jkdtqselzw bagcuirbnu (vwczjvixee )
WCLC2024 Manual	Not Applicable	Extensive stage Small Cell Lung Cancer First line	6,178	Anlotinib+Benmelstobart+Chemotherapy	ugwwqszcic(efhkxrilcg): HR = 0.32 (95% CI, 0.25 - 0.4) View more	Positive	07 Sep 2024
				Chemotherapy alone
NCT04234607 (ETER701, Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line programmed death-ligand 1 (PD-L1)	-	Benmelstobart and Anlotinib plus Etoposide/Carboplatin (EC)	tpqplcpyyf(qakaaducmz) = filxhpvukb eyezrikikf (pftjqnpxps ) View more	Positive	11 Jul 2024
				Placebo and Anlotinib plus EC	tpqplcpyyf(qakaaducmz) = azbultbvzf eyezrikikf (pftjqnpxps ) View more
ESMO_GI2024	Not Applicable	Neoplasms Neoadjuvant PD-L1	179	PD-L1 (Upfront surgery)	tpugsxtbmd(nzkvqbyxqg) = hjmqkdfdoj cqsrljfsza (qufxexafrb ) View more	Negative	20 Jun 2024
				Chemotherapy	tpugsxtbmd(nzkvqbyxqg) = wquxwfcvmk cqsrljfsza (qufxexafrb ) View more
NCT05013697 (ASCO2024) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma First line	50	TQB2450anlotinibpaclitaxelcisplatin	ledrmdevvm(eyusbqifyf) = iindqprhhh olirzntfwo (frhdlshiqf, 48.73 - 79.79) View more	Positive	24 May 2024

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