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更新于：2025-05-24

Izalontamab Brengitecan

伦康依隆妥单抗

更新于：2025-05-24

概要

基本信息

药物类型

ADC

别名

Zalontamab brengitecan、BL B01D1、BL-B01D1

+ [2]

靶点

EGFR x HER3 x Top I

作用方式

拮抗剂、抑制剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、HER3拮抗剂(受体酪氨酸蛋白激酶erbB-3拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)

治疗领域

肿瘤消化系统疾病口颌疾病+ [7]

在研适应症

膀胱尿路上皮癌复发性小细胞肺癌三阴性乳腺癌+ [52]

非在研适应症-

原研机构

Systimmune, Inc.

四川百利药业有限责任公司

在研机构

Bristol Myers Squibb Co.成都百利多特生物药业有限责任公司

Systimmune, Inc.

+ [2]

非在研机构-

权益机构

四川百利天恒药业股份有限公司

Bristol Myers Squibb Co.

上海迈邦生物科技有限公司

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评突破性疗法 (中国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

或

查看完整样例数据

Sequence Code 43254

来源: *****

Sequence Code 10172664

来源: *****

关联

项与伦康依隆妥单抗相关的临床试验

NCT06926868

/ Not yet recruiting临床2/3期

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

开始日期2025-07-15

申办/合作机构

Bristol Myers Squibb Co.

[+1]

NCT06978114

/ Not yet recruiting临床2期

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

This study is a clinical study to explore the efficacy and safety of BL-B01D1+PD-1/PD-L1 monoclonal antibody in patients with advanced biliary tract cancer.

开始日期2025-06-01

申办/合作机构

四川百利药业有限责任公司

[+1]

NCT06951464

/ Not yet recruiting临床2期IIT

A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy With BL-B01D1 in Combination With Almonertinib Followed by Adjuvant Almonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer

This is a Phase II, open-labeled, single-arm, study of neoadjuvant BL-B01D1in combination with Almonertinib followed by adjuvant Almonertinib for the treatment of Patients with EGFR-Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer.

开始日期2025-05-06

申办/合作机构

四川大学

100 项与伦康依隆妥单抗相关的临床结果

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100 项与伦康依隆妥单抗相关的转化医学

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100 项与伦康依隆妥单抗相关的专利（医药）

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项与伦康依隆妥单抗相关的文献（医药）

2024-07-01·CANCER TREATMENT REVIEWS

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies

Review

作者: Jiménez-Labaig, Pablo ; Braña, Irene ; Hernando-Calvo, Alberto ; Harrington, Kevin J ; Bhide, Shreerang ; Rullan, Antonio ; O'Leary, Ben ; Llop, Sandra

INTRODUCTION:

There is a need to improve the outcomes of patients with head and neck squamous cell carcinoma (HNSCC) and nasopharyngeal carcinoma (NPC), especially in recurrent unresectable and metastatic (R/M) setting. Antibody-drug conjugates (ADC) and bispecific antibodies (BsAb) may deliver promising results.

METHODS:

We conducted a systematic literature review to identify ADC and BsAb clinical trials, involving patients with HNSCC and NPC, from database creation to December 2023. We reported trial characteristics, overall response rate (ORR), overall survival (OS), and grade ≥ 3 treatment-related adverse events (trAEs).

RESULTS:

23 trials (65 % phase I) were found, involving 540 R/M patients (355 [20trials] HNSCC and 185 [5trials] NPC). There were 13 ADC (n = 343) and 10 BsAb (n = 197) trials. 96 % patients were refractory to standard of care treatments. ORR ranged from 0 to 100 %, with the highest ORR for GEN1042 plus chemoimmunotherapy. ORRs for monotherapies were 47 % for ADC, and 0-37 % for BsAb. MRG003 reached in HNSCC 43 % and NPC 47 %. BL-B01D1 54 % in NPC. Longest median OS was seen with MRG003 and KN046. Grade ≥ 3 trAEs were 28-60 % in ADC trials, and 3-33 % BsAb. Grade ≥ 3 myelosuppressive trAEs were typically seen in 8 ADC trials, while 4 BsAb showed infusion-related reactions (IRR). Four treatment-related deaths were reported (1 pneumonitis), all ADC trials.

CONCLUSION:

ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting.

2024-07-01·LANCET ONCOLOGY

BL-B01D1, a first-in-class EGFR–HER3 bispecific antibody–drug conjugate, in patients with locally advanced or metastatic solid tumours: a first-in-human, open-label, multicentre, phase 1 study

Article

作者: Chen, Likun ; Yang, Jun ; Guo, Ye ; Chen, Gang ; Zhu, Yi ; Zhou, Ningning ; Zhou, Huaqiang ; Yang, Kunyu ; Zhou, Ting ; Fu, Zhenming ; Zhang, Li ; Xiao, Sa ; Huang, Yan ; Zhao, Shen ; Zhao, Hongyun ; Liu, Qianwen ; Li, Yongsheng ; Fang, Wenfeng ; Zhang, Yaxiong ; Han, Yaqian ; Ma, Yuxiang ; Zhu, Hai ; Zhao, Yuanyuan ; Yang, Yunpeng ; Xue, Jinhui

BACKGROUND:

Antibody-drug conjugates have promising clinical activity in the treatment of solid tumours. BL-B01D1 is a first-in-class EGFR-HER3 bispecific antibody-drug conjugate. We aimed to assess the safety and preliminary antitumour activity of BL-B01D1 in patients with locally advanced or metastatic solid tumours.

METHODS:

This first-in-human, open-label, multicentre, dose-escalation and dose-expansion phase 1 trial was conducted in seven hospitals in China, enrolling patients aged 18-75 years (dose escalation; phase 1a) or older than 18 years (dose expansion; phase 1b), with a life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 0-1, and histologically or cytologically confirmed locally advanced or metastatic solid tumours that had progressed on current standard treatment. In the phase 1a i3+3 design, patients received intravenous BL-B01D1 at three different schedules: 0·27 mg/kg, 1·5 mg/kg, and 3·0 mg/kg weekly; 2·5 mg/kg, 3·0 mg/kg, and 3·5 mg/kg on days 1 and 8 of each cycle every 3 weeks; or 5·0 mg/kg and 6·0 mg/kg on day 1 of each cycle every 3 weeks. The primary objectives of phase 1a were to identify the safety, maximum tolerated dose, and dose-limiting toxicity. In phase 1b, patients were treated in two schedules: 2·5 and 3·0 mg/kg on days 1 and 8 every 3 weeks, or 4·5, 5·0, and 6·0 mg/kg on day 1 every 3 weeks. The primary objectives of phase 1b were to assess the safety and recommended phase 2 dose of BL-B01D1, and objective response rate was a key secondary endpoint. Safety was analysed in all patients with safety records who received at least one dose of BL-B01D1. Antitumour activity was assessed in the activity analysis set which included all patients who received at least one dose of BL-B01D1 every 3 weeks. This trial is registered with China Drug Trials, CTR20212923, and ClinicalTrials.gov, NCT05194982, and recruitment is ongoing.

FINDINGS:

Between Dec 8, 2021, and March 13, 2023, 195 patients (133 [65%] men and 62 [32%] women; 25 in phase 1a and 170 in phase 1b) were consecutively enrolled, including 113 with non-small-cell lung cancer, 42 with nasopharyngeal carcinomas, 13 with small-cell lung cancer, 25 with head and neck squamous cell carcinoma, one with thymic squamous cell carcinoma, and one with submandibular lymphoepithelioma-like carcinoma. In phase 1a, four dose-limiting toxicities were observed (two at 3·0 mg/kg weekly and two at 3·5 mg/kg on days 1 and 8 every 3 weeks; all were febrile neutropenia), thus the maximum tolerated dose was reached at 3·0 mg/kg on days 1 and 8 every 3 weeks and 6·0 mg/kg on day 1 every 3 weeks. Grade 3 or worse treatment-related adverse events occurred in 139 (71%) of 195 patients; the most common of which were neutropenia (91 [47%]), anaemia (76 [39%]), leukopenia (76 [39%]), and thrombocytopenia (63 [32%]). 52 (27%) patients had a dose reduction and five (3%) patients discontinued treatment due to treatment-related adverse events. One patient was reported as having interstitial lung disease. Treatment-related deaths occurred in three (2%) patients (one due to pneumonia, one due to septic shock, and one due to myelosuppression). In 174 patients evaluated for activity, median follow-up was 6·9 months (IQR 4·5-8·9) and 60 (34%; 95% CI 27-42) patients had an objective response.

INTERPRETATION:

Our results suggest that BL-B01D1 has preliminary antitumour activity in extensively and heavily treated advanced solid tumours with an acceptable safety profile. Based on the safety and antitumour activity data from both phase 1a and 1b, 2·5 mg/kg on days 1 and 8 every 3 weeks was selected as the recommended phase 2 dose in Chinese patients.

FUNDING:

Sichuan Baili Pharmaceutical.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

374

项与伦康依隆妥单抗相关的新闻（医药）

2025-05-23

·PRNewswire

SystImmune, Inc. to Present New izalontamab brengitecan (iza-bren) Data in Small Cell Lung Cancer and Non-Small Cell Lung Cancer with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations at ASCO Congress 2025

Initial safety & efficacy in patients with Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations will be presented from clinical studies evaluating iza-bren, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC) REDMOND, Wash., May 23, 2025 /PRNewswire/ -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that two abstracts on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30 – June 3 in Chicago. Iza-bren is being jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement. Expanded results from clinical trials of iza-bren will include data from patients with advanced stages of Small Cell Lung Cancer and Non-Small Cell Lung Cancer with driver genomic alterations (GA) outside of classic EGFR mutations and having multiple lines of prior therapies. The data to be presented at ASCO highlights continued progress in iza-bren clinical development and builds upon the previously reported clinical data in lung and breast cancer patients at ASCO, ESMO, and SABCS in 2023 and 2024. "Recent data have bolstered our confidence in iza-bren's safety profile while highlighting its encouraging efficacy across tumors that have been difficult to treat," stated Jonathan Cheng, M.D., CMO of SystImmune. "Iza-bren emerges as a promising therapeutic option, potentially fulfilling the unmet need of patients with few treatment alternatives. Our commitment to advancing this therapy through a series of comprehensive clinical trials remains steadfast, as we explore its potential both as a standalone treatment and in combination with other agents to improve cancer patient outcomes globally." Details on the presentations at ASCO are below: ‍‍ Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Abstract: 3001 Speaker: Yunpeng Yang (Guangzhou, China) Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Small Cell Lung Cancer (SCLC) Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Abstract: 3002 Speaker: Yan Huang (Guangzhou, China) Session Date & Time: Friday, May 30th, 2025, 2:45 PM-5:45 PM CDT About iza-bren The company is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent iza-bren has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Iza-bren blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, iza-bren is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death. About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. Forward-Looking Statements Any research and development information provided by SystImmune is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have medical conditions, please see your medical doctor or healthcare provider. This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflects the expectations regarding the company's goals, strategies, results of operations, performance, business prospects, and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as "anticipates," "believes," "expects," "estimates," "could," "intends," "may," "plans," "potential," "projects," "will," "would" and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements. While SystImmune, Inc. believes that expectations expressed in the forward-looking statements are based on the company's reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. For additional information about the company, please visit . SOURCE SystImmune, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出临床1期ASCO会议抗体药物偶联物

2025-05-22

·医药速览

2025ASCO肺癌口头汇报的重磅研究 495

美国临床肿瘤学会（ASCO）2025年会已于昨日公布完整日程。大会时间：5.30-6.3（The abstract will be released to the public on 2025年5月23日 GMT+8 05:00详细摘要内容5月23号公布，大概是会前一周公布）2025 ASCO：ADC、双抗/多抗，有哪些看点？（附一览表）整个会议共接收6339篇摘要，其中壁报Poster展示合计2492篇；Oral和Rapid oral各 212篇、206篇等。单纯摘要发表（publication only）3379篇；肺癌的口头汇报研究整理如下：小细胞肺癌LBA8008Tarlatamab对比化疗（CTx）作为小细胞肺癌（SCLC）二线（2L）治疗：III期DeLLphi-304主要分析。Abstract #8006Lurbinectedin（lurbi）+ 阿替利珠单抗（atezo）作为广泛期小细胞肺癌（ES-SCLC）一线（1L）维持治疗（tx）：III期IMforte试验主要结果。Abstract #3002（中山大学肿瘤防治中心黄岩教授）Iza-Bren（BL-B01D1）（一种EGFR x HER3双特异性抗体药物偶联物（ADC））在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究。Abstract #LBA8005放化疗（CRT）后阿替利珠单抗（atezo）延长局限期（LS）小细胞肺癌（SCLC）生存期的随机II期试验。Abstract #8013Lurbinectedin联合阿替利珠单抗作为晚期小细胞肺癌二线治疗的安全性和有效性：2SMALL I/II期研究（NCT04253145）结果。Abstract #8014ADRIATIC试验中早期进展者（EPs）与长期无进展生存者（LTPs）的临床和分子特征：局限期小细胞肺癌（LS-SCLC）同步放化疗（cCRT）后巩固度伐利尤单抗（D）对比安慰剂（P）的III期研究。围术期/早期肺癌Abstract #8009可切除非小细胞肺癌（R-NSCLC）患者术后MRD状态与术前ctDNA动态、基因组突变及临床结局的关联：III期AEGEAN试验。Abstract #LBA8000CheckMate 816中新辅助纳武利尤单抗（NIVO）+化疗（chemo）治疗可切除NSCLC患者的总生存期（OS）。Abstract #8001新辅助奥希替尼（osi）±化疗（CT）对比单纯化疗治疗可切除EGFR突变（EGFRm）NSCLC：NeoADAURA。Abstract #LBA8010CheckMate 77T中可切除NSCLC患者围手术期纳武利尤单抗（NIVO）对比安慰剂（PBO）的更新生存和生物标志物分析。晚期/局部晚期肺癌Abstract #8514Benmelstobart联合化疗序贯安罗替尼一线治疗局部晚期或转移性鳞状非小细胞肺癌（sq-NSCLC）的III期研究。Abstract #LBA8502CAMPASS：Benmelstobart联合安罗替尼对比帕博利珠单抗（pembro）一线治疗晚期NSCLC的随机、单盲、多中心III期研究。Abstract #8516免疫化疗每日时机对NSCLC患者无进展生存期（PFS）和总生存期（OS）影响的随机试验。Abstract #8500KRYSTAL-7研究II期部分：Adagrasib（ADA）联合帕博利珠单抗（PEMBRO）一线治疗晚期/转移性KRASG12C突变NSCLC。Abstract #8012InTRist：诱导特瑞普利单抗（toripalimab）+化疗序贯同步放化疗及巩固特瑞普利单抗治疗不可切除III期NSCLC的随机II期初步结果。ADC或免疫联合ADCAbstract #8507（中山大学肿瘤防治中心张力教授）Sacituzumab tirumotecan（sac-TMT）治疗既往经治的晚期EGFR突变NSCLC：随机OptiTROP-Lung03研究结果。Abstract #2005Patritumab deruxtecan（HER3-DXd）治疗活动性脑转移（BM）（乳腺癌和NSCLC）及晚期实体瘤软脑膜转移（LMD）：TUXEDO-3 II期试验。Abstract #8501TROPION-Lung02：Dato-DXd联合帕博利珠单抗（pembro）±铂类化疗（Pt-CT）一线治疗晚期NSCLC。双抗ADCAbstract #3001（中山大学肿瘤防治中心杨云鹏教授）Iza-Bren（BL-B01D1）（一种EGFR x HER3双特异性抗体药物偶联物（ADC））在驱动基因变异（非经典EGFR突变）的晚期/转移性NSCLC患者中的I期研究。双抗（进行中研究）Poster Bd #135bHARMONi-3：依沃西单抗（ivonescimab）+化疗对比帕博利珠单抗（pembro）+化疗一线治疗转移性NSCLC的随机III期研究。原始英文的筛选：小细胞肺癌：LBA8008Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.Abstract #8006Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.Abstract #3002 （中肿黄岩教授）Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).Abstract #LBA8005Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).Abstract #8013Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).Abstract #8014Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).围术期早期肺癌：Abstract #8009Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.Abstract #LBA8000Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.Abstract #8001Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURAAbstract #LBA8010Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: updated survival and biomarker analyses from CheckMate 77T.晚期局部晚期肺癌：Abstract #8514Phase 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).Abstract #LBA8502CAMPASS: 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.Abstract #8516Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.Abstract #8500First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.Abstract #8012The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).ADC或免疫联合ADC：Abstract #8507（中肿张力教授）Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.Abstract #2005Patritumab deruxtecan (HER3-DXd) in active brain metastases (BM) from metastatic breast (mBC) and non–small cell lung cancers (aNSCLC), and leptomeningeal disease (LMD) from advanced solid tumors: Results from the TUXEDO-3 phase II trial.Abstract #8501TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).双抗ADC：Abstract #3001（中肿杨云鹏教授）Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.双抗进行中研究：Poster Bd #135bA randomized phase 3 study of ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy for the first-line treatment of metastatic non–small cell lung cancer: HARMONi-3.推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©2021 医药速览保留所有权利往期链接“小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记PROTAC技术| 抗体药物| 抗体药物偶联-ADC核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

临床结果ASCO会议抗体药物偶联物临床3期临床2期

2025-05-22

·抗体圈

下一个三生制药，开始爆

三生制药的成功让大家看到了一些老牌药企老树开新花的价值。它们在之前或许做原料药，或许做制剂，或许在仿制药深耕许多年，但他们都有着向创新药管线深凿的决心，如今巨额的BD Deal便是他们转型深耕的最强明证。目前国内转型创新的老牌药企，远远不止三生制药。生长激素龙头金赛药业在近日举办了研发日活动，让大家看到了其创新药管线的全新风貌，管线梯队中有一部分值得分别进行拆解，本文希望能为读者对管线价值带来直观的认识。01肿瘤管线如图所示，金赛药业在肿瘤领域方面布局非常前沿，包括双抗、双靶点ADC等，其中金赛药业重点对GenSci143和GenSci139做了重点介绍。GenSci143是同靶点类型中的first in class，靶向B7H3和PSMA的双抗ADC，如图所示，可以看到它的抗体采用的是非对称IgG结构，通过KIH和Crossmab解决重轻链错配问题。这里解释一下，KIH指的是knobs-into-holes，这个技术可以说是双抗发展的里程碑，突破了双抗在产量和纯度上的技术瓶颈，实现了产量纯度双提升并很大程度上限制了非目的产物即错配的形成。大概解释来说，就是把其中的氨基酸位点进行突变使其分别呈现knob和hole的结构，具体这里不做太繁杂的拆解。而Crossmab则是罗氏开发的技术，也是用于解决双抗中轻重链之间正确组合的问题。简单来说，这两种技术都是对于双抗，以及双抗ADC开发过程中的里程碑技术，使得目标产物的纯度可以得到极大程度的提升。linker方面只披露了是高亲水的linker，我们这里还看不到更多的信息，而payload——GSC5181看得出是在dxd上改良的产物，且有着比dxd更强的活性，在细胞模型中展现了强劲的药效。总体而言，这款双抗ADC还是让人眼前一亮的，一项是它的靶点，布局的其中一个靶点是PSMA，也许未来会在前列腺癌上有着不俗的战果，迭代目前的单抗PSMA ADC。此外，它另一个靶点B7-H3是目前潜在的万金油靶点，也许可以在NSCLC这样的大癌种上有着不错的疗效，使得适应症空间得到大大的延展。而GenSci139靶向EGFR与Her2这两个经典靶点，也是全球first in class的双抗ADC，如图所示，抗EGFR的臂是Fab，抗HER2的臂是ScFv，同样用了KIH技术，毒素同样是GSC5181。其采用的是定点偶联技术，DAR值为6，定点偶联让DAR值更加具有均一性。从图中我们可以看到，该双抗ADC在细胞系中体现出了比DS-8201更强的毒性和旁观者效应。光这两条ADC管线，也可以让金赛药业在二级市场有着十足的想象力了，两条管线都是全球首发的first in class双抗ADC，而现在一些青黄不接的MNC就缺前沿的ADC管线，它们也很着急，最近在中国扫货的心更加迫切。但是目前，我们作为二级投资者而言的话，还是需要看到这两条双抗ADC的确定性：I期临床试验的数据，两款管线预计递交IND的时间为2025年8月，也就是说最早可以在明年8月左右看到临床I期数据。然后就是预期的BD金额问题了，作为First in class双抗ADC，我们当然不希望它像大部分单抗ADC那样首付几千万美元，总付款十亿美元左右就能买回家。毕竟BMS买百利天恒的BL-B01D1卖出了8亿美元首付款，84亿交易总额的天价。之后的BD或许不好超越这个创纪录的数字，毕竟BL-B01D1是断层式进度领先的双抗ADC，但是毕竟双抗ADC适应症肯定远比单抗适应症要广，还是应该在价格上达到原有单抗ADC的两倍以上的。02肿瘤之外肿瘤管线之外，首先值得一提的是已经上市的金蓓欣（伏欣奇拜单抗），它是国内第一款获批上市的IL-1β单克隆抗体，也是第一个针对白介素-1靶点的制剂。而它的市场是目前最有潜力的炎症市场之一：痛风市场。根据《痛风及高尿酸血症基层诊疗指南（2019 年）》数据，近几年中国高尿酸血症和痛风患病率显著增高，高尿酸血症患者已占总人口13.3%，而痛风患病率在1%~3%，根据华源证券的估算，目前中国痛风患者人数已经超过千万。并且2030年，我国痛风药物市场规模将达108亿元。虽然降尿酸药物在发挥着作用，但尿酸的过程是漫长的，而在这个过程中患者需要经受着病痛的折磨，此外，还有可能降尿酸疗效不佳，随后又重新进入病痛的炎症阶段，因此，抗炎和降尿酸在治疗痛风的过程中同样重要。而金蓓欣的疗效，就在着这之中展现了出来。数据显示，给药后12周，伏欣奇拜单抗组对比得宝松组降低90%（HR=0.10，p<0.0001）的首次复发风险，给药后24周，伏欣奇拜单抗组对比得宝松组降低87%（HR=0.13，p<0.0001）的首次复发风险，创同类药物最优纪录。并且该药在给药依从性上也有着优势：。临床数据显示，患者一年仅需两针，就能实现365天不发作；6小时就能快速起效，6-72小时镇痛效果与激素相当，6个月内首次复发风险降低近90%；且未发现严重不良反应。金蓓欣正在朝着国内第一大炎症创新药单品迈进。而在研的管线之中，非常有想象力的就是在研的PD-1激动剂——GenSci120。关于PD-1激动剂的机制和管线拆解我们曾经在文章《新型PD-1捅破天》中进行了较为详细的叙述，这个靶点药物目前的主要推进管线是类风湿性关节炎，此外，之后它计划攻克的适应症是溃疡性肠炎。而GenSci120布局的适应症包括类风湿性关节炎，溃疡性肠炎，系统性红斑狼疮，原发性干燥综合征。布局非常广，有着成为自免炎症领域下一个爆款单品的雄心。但是PD-1激动剂目前还是缺乏三期临床的验证，最快的应该是ANAB的Rosnilimab，目前有了临床IIb期的数据，BD的话目前还是偏向于挑选确定性强的靶向进行BD，PD-1还是太过早期，需要进一步的发展。此外，目前比较有BD看点的是金赛药业之后数条TL1A相关的管线，是否会在肠炎领域大放异彩，该靶点是肠炎领域目前极其红火的靶点，BD的机会比PD-1激动剂还是要大一些。03结语我们谈了这么多，更多围绕BD去谈的，昨天三生制药的BD给了很多二级投资者极其高的期待：因为只要BD出一个超级大单品，可能收到的首付款就能达到目前市值的三分之一，直接拉升30%以上的市值，这种诱人程度让大多数二级投资者都会去押一些药企的BD。而从目前来看，或许押这种老牌药企的BD比押小biotech的BD风险更小，毕竟小biotech波动太大，风险太高，而老牌药企则有基本的经营业绩作为保证，不会出现股价动辄20%以上大起大落的情况，而且只要押中一个BD，就是10%以上的大涨。这种情况之下，去押老牌药企的BD无疑是性价比高，风险小，收益更加稳定的选择。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物

100 项与伦康依隆妥单抗相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
膀胱尿路上皮癌	临床3期	中国	四川百利药业有限责任公司	2025-03-25
复发性小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-08-07
三阴性乳腺癌	临床3期	中国	四川百利药业有限责任公司	2024-06-21
EGFR突变的非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-05-22
转移性非鳞状非小细胞肺癌	临床3期	中国	四川百利药业有限责任公司	2024-05-22
HR阳性乳腺癌	临床3期	中国	四川百利药业有限责任公司	2024-04-24
HR阳性/HER2阴性乳腺癌	临床3期	中国	四川百利药业有限责任公司	2024-04-24
食管鳞状细胞癌	临床3期	中国	四川百利药业有限责任公司	2024-03-19
转移性食管鳞状细胞癌	临床3期	中国	四川百利药业有限责任公司	2024-03-19
鼻咽癌	临床3期	中国	四川百利药业有限责任公司	2023-12-04

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05262491 (BL-B01D1, ESMO2024) 人工标引	临床1期	胆道癌	39	BL-B01D1 2.5 mg/kg	餘齋鬱窪膚選艱顧鹹鹽(衊鬱鑰鏇淵網鏇顧遞鑰) = 範齋鏇醖繭鹽衊願壓醖艱鹹餘齋餘製範構構觸 (膚簾艱醖糧簾選窪簾遞 ) 更多	积极	2024-09-16
NCT05262491 (ESMO2024) 人工标引	临床1期	食管鳞状细胞癌	83	BL-B01D1 2.0 mg/kg	鏇獵鏇齋網簾願鏇遞蓋(鬱範夢艱鏇選膚憲淵糧) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) 範襯廠獵願憲艱廠製蓋 (觸繭鹽壓衊獵願膚獵憲 ) 更多	积极	2024-09-16
NCT05262491 (ESMO2024) 人工标引	临床1期	食管鳞状细胞癌	83	BL-B01D1 2.5 mg/kg		积极	2024-09-16
NCT05785039 (BL-B01D1, ESMO2024)	临床1/2期	转移性尿路上皮癌	32	BL-B01D1 2.2 mg/kg	繭願艱繭壓鏇鹽鑰繭襯(膚鬱選願積築鏇窪襯鏇) = 22%/0% at 2.2mg/kg 憲網積齋遞構選觸選網 (願鹹簾簾願簾鹽衊餘選 ) 更多	积极	2024-09-13
CTR20212923 \| NCT05194982 (Pubmed) 人工标引	临床1期	实体瘤	195	BL-B01D1 0.27 mg/kg	夢艱膚選選糧鑰願糧齋(衊觸遞願簾齋壓遞選範) = 積顧餘選壓鹹窪積艱獵窪選獵繭鹹鬱糧獵艱齋 (廠壓範糧膚糧齋遞積膚 ) 更多	积极	2024-07-01
NCT05470348 (PRNewswire) 人工标引	临床1期	乳腺癌 ER Negative \| HER2 Negative \| PR Negative \| ... 更多	127	BL-B01D1	觸壓製壓夢憲窪鬱顧夢(遞繭蓋淵範壓蓋憲築膚) = 觸繭餘選蓋廠顧觸簾顧製衊範遞築簾壓廠餘簾 (積範夢淵鏇餘網鏇夢鑰 ) 更多	积极	2023-12-05
NCT05194982 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	非小细胞肺癌 EGFR	114	BL-B01D1	蓋網築遞築淵繭網鹽鬱(憲構糧蓋糧選糧艱簾選) = 壓鏇鏇淵膚網衊窪製壓選簾簾鏇顧衊觸觸鹽鏇 (簾選積鹽遞夢顧鬱觸夢 )	积极	2023-10-21
NCT05194982 (ESMO 12023 \| ESMO 22023) 人工标引	临床1期	非小细胞肺癌 EGFR	114	BL-B01D1 (EGFRmut)	顧齋繭繭積網顧餘醖夢(醖淵蓋繭醖膚壓膚淵鬱) = 壓廠構選簾壓選遞製觸齋糧廠簾壓簾願夢範築 (遞廠願顧夢繭襯憲獵顧, 75.2 ~ 97.1) 更多	积极	2023-10-21
NCT05194982 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性实体瘤	120	BL-B01D1 (EGFRmut + NSCLC)	蓋網築壓獵鏇艱衊構壓(範遞襯艱衊醖憲築糧窪) = neutropenia, febrile neutropenia and thrombocytopenia at 3.0mg/kg QW and 3.5mg/kg D1D8 Q3W 鹽鑰鹹繭膚齋顧糧構壓 (築淵醖範壓衊壓艱糧壓 ) 更多	积极	2023-05-31
NCT05194982 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	转移性实体瘤	120	BL-B01D1 (EGFRwt + NSCLC)		积极	2023-05-31