Last update 31 Dec 2024
Becotatug vedotin
Last update 31 Dec 2024
Overview
Basic Info
Drug Type Antibody drug conjugate (ADC) |
Synonyms MRG 003, MRG-003 |
Target |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), Tubulin inhibitors |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN) |
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Gene Sequence
Sequence Code 756146862L
Source: *****
Sequence Code 756146864H
Source: *****
Related
19
Clinical Trials associated with Becotatug vedotinA Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
MRG003对比西妥昔单抗/甲氨蝶呤在二/三线治疗复发或转移性头颈鳞癌患者的随机、开放、多中心III期研究
[Translation] A randomized, open-label, multicenter phase III study of MRG003 versus cetuximab/methotrexate in the second/third-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
A Randomized, Open-Label, Multicenter, Phase III Study to Evaluate MRG003 vs Cetuximab/Methotrexate as Second/Third Line of Treatment in Patient With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN)
100 Clinical Results associated with Becotatug vedotin
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100 Translational Medicine associated with Becotatug vedotin
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100 Patents (Medical) associated with Becotatug vedotin
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4
Literatures (Medical) associated with Becotatug vedotin31 Dec 2025mAbs
Antibodies to watch in 2025
Review
Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin
The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.
01 Jul 2022JAMA oncologyQ1 · MEDICINE
Evaluation of Safety of Treatment With Anti–Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors
Q1 · MEDICINE
Article
Author: Guo, Ye ; Zhang, Yang ; Nian, Weiqi ; Liao, Wangjun ; Li, Hu ; Wu, Yunteng ; Xu, Rui-Hua ; Wei, Xiaoli ; Hu, Chaohong ; Xu, Zhongyuan ; Qiu, Miao-Zhen ; Zhang, Wenxue ; Xue, Liqiong ; Ren, Guoxin ; Tang, Wenbo ; Jin, Yongshuai ; Wang, Ling ; Guo, Wei ; Xi, Jingle ; Zhao, Hong-Yun
Importance:
The antibody drug conjugate drug MRG003 comprises an anti-epidermal growth factor receptor (EGFR) humanized immunoglobulin G1 monoclonal antibody that is conjugated with monomethyl auristatin E via a valine-citrulline linker. There is currently insufficient evidence of this drug's safety and efficacy.
Objective:
To evaluate the safety and maximum tolerated dose of MRG003 in a phase 1a study and investigate the preliminary antitumor activity in EGFR-expressing patients in a phase 1b study.
Design, Setting, and Participants:
This nonrandomized open-label, single-arm, phase 1, multicenter study of solid tumors was divided into 2 parts, phase 1a dose escalation and phase 1b dose expansion. Patients with advanced or metastatic solid tumors who had failed outcomes from or were not able to receive standard treatment were enrolled in phase 1a without EGFR prescreening. Phase 1b recruited EGFR-positive patients with refractory advanced squamous cell carcinomas of the head and neck (SCCHN), nasopharyngeal carcinoma (NPC), and colorectal cancer (CRC). This study was conducted at 7 Chinese centers between April 11, 2018, and March 29, 2021 (data cutoff date). Data analysis took place between April 2021 and June 2021.
Interventions:
An intravenous dose of 0.1 to 2.5 mg/kg of MRG003 was administered every 3 weeks during phase 1a. During phase 1b, patients were administered the recommended dose identified in phase 1a.
Main Outcomes and Measures:
The primary end points were dose-limiting toxic effects in phase 1a and objective response rate in phase 1b. The safety, tolerability, immunogenicity, and pharmacokinetics of MRG003 were assessed. Tumor assessment was evaluated by RECIST 1.1.
Results:
Twenty-two patients (mean [range] age, 54.5 [32.0-67.0] years; 9 women [41%]) were enrolled in phase 1a and 39 patients (mean [range] age, 50.4 [27.0-75.0] years; 8 women [21%]) in phase 1b. The recommended dose was identified as 2.5 mg/kg. Eighty-nine percent of adverse events (AEs) were associated with MRG003 treatment, and most AEs were grade 1 to 2. Nineteen patients (31%) reported grade 3 or greater treatment-related AEs, including hyponatremia, leukocytopenia, neutropenia, increased aspartate aminotransferase levels, and febrile neutropenia. In phase 1a, 1 patient (5%) achieved a partial response, and 5 (23%) achieved stable disease. In phase 1b, 8 patients (21%) achieved a confirmed partial response, and 12 (31%) achieved stable disease. The objective response rates for SCCHN, NPC, and CRC were 40%, 44%, and 0%, and the disease control rates were 100%, 89%, and 25%, respectively.
Conclusions and Relevance:
The findings of this nonrandomized clinical trial suggest that MRG003 showed a manageable safety profile and promising antitumor activity in patients with EGFR-positive NPC and SCCHN.
Trial Registration:
Clinicaltrials.gov Identifier: NCT04868344.
Frontiers in molecular biosciencesQ3 · BIOLOGY
Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers
Q3 · BIOLOGY
ReviewOA
Author: Yu, Jinfeng ; Fang, Tong ; Cai, Xiaoqing ; Yun, Chengyu ; Liu, Xue
Members of the human epidermal growth factor receptor (HER) family, which includes HER1 (also known as EGFR), HER2, HER3 and HER4, have played a central role in regulating cell proliferation, survival, differentiation and migration. The overexpression of the HER family has been recognized as one of the most common cellular dysregulation associated with a wide variety of tumor types. Antibody-drug conjugates (ADCs) represent a new and promising class of anticancer therapeutics that combine the cancer specificity of antibodies with cytotoxicity of chemotherapeutic drugs. Two HER2-directed ADCs, trastuzumane-emtansine (T-DM1) and trastuzumab-deruxtecan (DS-8201a), have been approved for HER2-positive metastatic breast cancer by the U.S. Food and Drug Administration (FDA) in 2013 and 2019, respectively. A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. A total of 11 ADCs that target HER family receptors (EGFR, HER2 or HER3) are currently under clinical trials. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
100 Deals associated with Becotatug vedotin
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Nasopharyngeal Carcinoma | NDA/BLA | CN | 25 Sep 2024 | |
| Nasopharyngeal Carcinoma | NDA/BLA | CN | 25 Sep 2024 | |
| Squamous cell carcinoma of head and neck metastatic | Phase 3 | CN | 01 Mar 2023 | |
| EGFR mutation Solid Tumors | Phase 2 | CN | 30 Jun 2022 | |
| Nasopharyngeal Cancer, Recurrent | Phase 2 | CN | 04 Aug 2021 | |
| Advanced gastric carcinoma | Phase 2 | CN | 24 May 2021 | |
| Metastatic Gastric Carcinoma | Phase 2 | CN | 24 May 2021 | |
| Metastatic Gastroesophageal Junction Adenocarcinoma | Phase 2 | CN | 24 May 2021 | |
| adenocarcinoma of biliary tract | Phase 2 | CN | 28 Apr 2021 | |
| Advanced Bile Duct Carcinoma | Phase 2 | CN | 28 Apr 2021 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 2 | 30 | yoplhyvmjr(qusdywzjfj) = yurplysjlo fzfybwslam (yqdthbfduv, 59.7 - 73.7) View more | Positive | 07 Dec 2024 | |||
Phase 1/2 | EGFR mutation Solid Tumors EGFR-positive | 33 | hokhzcsoqu(azxpdahmoh) = pgzkdjebio wfkoztwmco (tcyzoyrqmo ) View more | Positive | 24 May 2024 | ||
Phase 2 | Squamous Cell Carcinoma of Head and Neck EGFR expression | 67 | rzjyfwroyx(zbpdzzuccs) = clnqsjwgoh qxjnusdvdp (pkjmzrdtqf ) | Positive | 22 Oct 2023 | ||
(2.3 mg/kg) | rzjyfwroyx(zbpdzzuccs) = bokbqsfwdy qxjnusdvdp (pkjmzrdtqf ) View more | ||||||
Phase 2 | 61 | hnkxjfzhgk(vmdsarukcb) = fswjzwsozd kbmfsciydt (hvyhdohvsb ) View more | Positive | 21 Oct 2023 | |||
hnkxjfzhgk(vmdsarukcb) = nfvevwughn kbmfsciydt (hvyhdohvsb ) View more | |||||||
Phase 2 | Nasopharyngeal Cancer, Recurrent Last line | 61 | cwqpklvjeh(zoumysbkgx) = jwmwxbgfhs hnezgdcjrl (lesczxbxss ) View more | Positive | 21 Sep 2022 | ||
cwqpklvjeh(zoumysbkgx) = sckjahtmdu hnezgdcjrl (lesczxbxss ) View more | |||||||
Phase 1 | 61 | (phase 1a) | mkcsaisrag(hoyohpbpfs) = qtkmijlqin bdihxrmdci (mpndpmnhsq ) View more | Positive | 05 May 2022 | ||
(phase 1b) | paagcrszss(inqeckhblp) = pynjfruzdy njvwhlihei (ilnowfsrlq ) View more | ||||||
Phase 1 | 22 | gftfhphylt(awqzwztnwt) = 30% chuobvpalt (lngdvfkjpe ) View more | - | 16 Sep 2021 | |||
Phase 1 | 22 | pcnjzehggf(gmftnqhhzw) = zigusibgff ncvngrwxuf (yfqpgtlppp ) View more | Positive | 25 May 2020 |
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