2023 ESMO前瞻︱恒瑞医药13款抗肿瘤创新药的35项研究成果将亮相国际舞台

2023-10-09

抗体药物偶联物临床2期临床结果临床1期临床3期

2023年欧洲肿瘤内科学会（ESMO）大会将于10月20日至24日（中欧夏令时间CEST）在西班牙马德里召开。作为全球最具影响力的肿瘤学会议之一，ESMO官方近日公布了此次大会摘要题目，恒瑞医药共有13款抗肿瘤创新药的35项研究成果入围，其中2项入选优选口头（Proffered Paper）报告，5项研究入选简短口头（Mini Oral）报告，28项研究接收为壁报，覆盖消化道肿瘤、乳腺癌、宫颈癌、胰腺癌、肺癌、黑色素瘤、肉瘤、胆管癌等十余个领域。

实体瘤

SHR-1701、SHR-A2009、SHR-A1811、HRS-4642相关共4项研究

1、新型KRAS G12D抑制剂HRS-4642在KRAS G12D突变晚期实体瘤 KRAS G12D突变晚期实体瘤患者中的首次人体1期研究（入选优选口头报告）

LBA33：A first-in-human phase 1 study of a novel KRAS G12D inhibitor HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation

PI/汇报人：上海市肺科医院周彩存

2. 靶向HER2-ADC HER2-ADC SHR-A1811治疗HER2表达/突变的晚期非乳腺的实体瘤（STs）HER2表达/突变的晚期非乳腺的实体瘤（STs）：来自全球1期研究的结果

656MO：The HER2-targeting ADC SHR-A1811 in HER2-expressing/mutated advanced non-breast solid tumors (STs): results from the global phase 1 study

PI/汇报人：中山大学孙逸仙纪念医院姚和瑞

3. 靶向HER3-ADC SHR-A2009 HER3-ADC SHR-A2009在晚期实体瘤中的1期研究

658MO：Phase 1 study of SHR-A2009, a HER3-targeted ADC, in advanced solid tumors

PI/汇报人：广东省人民医院肿瘤医院周清

4. SHR-1701（一种抗PD-L1/TGF-βRII双抗药物）联合贝伐珠单抗（BEV）治疗晚期实体瘤患者的1b/2期研究

1026MO：A phase 1b/2 study of SHR-1701 (a bifunctional anti-PD-L1/TGF-βRII agent) in combination with bevacizumab (BEV) in patients with advanced solid tumors

PI/汇报人：中山大学肿瘤医院徐瑞华

消化道肿瘤

卡瑞利珠单抗、阿帕替尼、SHR-A1811、SHR-1701相关共11项研究

5. 局部晚期直肠癌新辅助短程放疗序贯卡瑞利珠单抗联合化疗与长程放化疗序贯化疗的比较：一项随机III期研究（UNION）（入选优选口头报告）

LBA25：Neoadjuvant short-course radiotherapy followed by camrelizumab plus chemotherapy versus long-course chemoradiotherapy followed by chemotherapy in locally advanced rectal cancer:a randomized phase III trial(UNION)

PI/汇报人：华中科技大学同济医学院附属协和医院张涛、陶凯雄

6. 局部晚期可切除胃或胃食管交界癌（G/GEJ）围手术期卡利珠单抗联合阿帕替尼和化疗对比化疗：随机3期研究（DRAGON IV）的首次中期分析

1512MO：Perioperative camrelizumab (C) combined with rivoceranib (R) and chemotherapy (chemo) versus chemo for locally advanced resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: the first interim analysis of a randomized, phase 3 trial (DRAGON IV)

PI/汇报人：上海交通大学医学院附属瑞金医院朱正纲李琛

7. SHR-1701联合BP102和XELOX用于不可切除的转移性结直肠癌（mCRC）患者的一线治疗：来自2/3期研究数

611P：SHR-1701 in combination with BP102 and XELOX as first-line (1L) treatment for patients (pts) with unresectable metastatic colorectal cancer (mCRC): data from a phase 2/3 study

PI/汇报人：中山大学肿瘤医院徐瑞华

8. 维莫非尼、西妥昔单抗联合卡瑞利珠单抗治疗BRAF V600E突变/MSS转移性结直肠癌 BRAF V600E突变/MSS转移性结直肠癌的耐受性和安全性

624P：Tolerability and Safety of Vemurafenib, Cetuximab Combined with Camrelizumab for BRAF V600E-mutated /MSS Metastatic Colorectal Cancer

PI/汇报人：四川大学华西医院邱萌

9. 一项1b/2期开放标签研究（NCT04073615）旨在评估阿帕替尼联合曲氟尿苷/替吡嘧啶治疗经治转移性结直肠癌患者的安全性、耐受性和疗效

644P：Phase 1b/2 Open-label Study (NCT04073615) to Evaluate the Safety, Tolerability, and Efficacy of Rivoceranib plus Trifluridine/Tipiracil in Patients with Previously Treated Metastatic Colorectal Cancer

PI/汇报人：Vanderbilt University Medical Center Cathy Eng

10. SHR-A1811治疗HER2+晚期胃癌（GC）GC）或胃食管交界癌（GEJ）及结直肠癌（CRC）的1期研究

684P：Phase 1 trial of SHR-A1811 in HER2-expressing advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) and colorectal cancer (CRC)

PI/汇报人：复旦大学附属肿瘤医院李进

11. 卡瑞利珠单抗联合化疗对比同步放化疗作为可切除胸段食管鳞癌（REVO）的新辅助治疗：一项多中心、随机、开放标签、2期研究

1522P：Camrelizumab plus chemotherapy versus concurrent chemoradiotherapy as neoadjuvant therapy for resectable thoracic esophageal squamous cell cancer（REVO) : A multicenter, randomized, open-label, phase 2 trial

PI/汇报人：福建省肿瘤医院柳硕岩

12. 卡瑞利珠单抗联合化疗新辅助治疗术前可切除食管鳞癌（ESCC）患者的探索性临床研究初步结果

1541P：Neoadjuvant therapy of camrelizumab combined with chemotherapy in patients (pts) with resectable esophageal squamous cell cancer (ESCC) preliminary results of a preoperative phase exploratory clinical trial

PI/汇报人：山东省肿瘤医院董印军

13. 卡瑞利珠单抗联合多西他赛和卡铂新辅助治疗局部晚期食管鳞癌的临床研究

1543P：Clinical study of camrelizumab combined with docetaxel and carboplatin in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma

PI/汇报人：河北医科大学第四医院王瑞

14. 卡瑞利珠单抗联合白蛋白紫杉醇和S-1作为晚期胃/胃食管交界癌的一线治疗：一项II期临床研究

1544P：Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment of advanced gastric/gastroesophageal junction cancer: a phase II clinical trial

PI/汇报人：河南省肿瘤医院侯新芳

15. 卡瑞利珠单抗联合mFLOT方案在初始不可切除的局部晚期或局限性转移性胃或胃食管交界癌（GEJ）患者中的转化效果

1584P：Conversion effect of PD-1 antibody camrelizumab(Cam) combined with modified FLOT (mFLOT) regimen in patients(pts) with initially unresectable locally advanced or limited metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

PI/汇报人：复旦大学附属肿瘤医院耿其荣

肝胆胰腺肿瘤

氟唑帕利、阿得贝利单抗（SHR-1316）相关共2项研究

16. 阿得贝利单抗联合IBI310治疗一线治疗失败后的晚期肝内胆管癌患者的一项2期研究

105P：A phase 2 study of SHR-1316 plus IBI310 in patients with advanced intrahepatic cholangiocarcinoma after failure of first-line therapy

PI/汇报人：复旦大学附属中山医院樊嘉

17. 氟唑帕利联合mFOLFIRINOX 后维持氟唑帕利一线治疗不可切除的局部晚期或转移性（LA/M）胰腺癌（PC）患者：一项1b期研究

1627P：First-line (1L) fuzuloparib plus mFOLFIRINOX followed by maintenance fuzuloparib in patients (pts) with unresectable locally advanced or metastatic (LA/M) pancreatic cancer (PC): a phase 1b study

PI/汇报人：复旦大学附属肿瘤医院虞先濬

乳腺癌

吡咯替尼、卡瑞利珠单抗、阿帕替尼、法米替尼、HRS8807相关共9项研究

18. 基于阿帕替尼的治疗方案对于转移性三阴性乳腺癌中临床价值的真实世界研究

423P：A real-world study on the clinical value of apatinib-based regimens in metastatic triple-negative breast cancer

PI/汇报人：福建省肿瘤医院黄伟炜

19. 吡咯替尼联合卡培他滨治疗曲妥珠单抗耐药的HER2阳性晚期乳腺癌 HER2阳性晚期乳腺癌：2期PICTURE研究的最新生存结果

424P：Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer: updated survival results from the phase 2 PICTURE trial

PI/汇报人：复旦大学附属肿瘤医院胡夕春

20. FUTURE-C-PLUS的总生存报告：评估法米替尼联合卡瑞利珠单抗加白蛋白紫杉醇晚期一线治疗免疫调节型三阴性乳腺癌的一项开放标签、单臂、二期研究

426P：The overall survival data of FUTURE-C-PLUS: combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for advanced, immunomodulatory triple-negative breast cancer, an open-label, single-arm, phase 2 trial

PI/汇报人：复旦大学附属肿瘤医院王中华

21. 吡咯替尼联合曲妥珠单抗对比帕妥珠单抗联合曲妥珠单抗治疗HER2阳性转移性乳腺癌 HER2阳性转移性乳腺癌：一项多中心、回顾性研究

427P：Pyrotinib Plus Trastuzumab versus Pertuzumab Plus Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer: A Multicenter, Retrospective Study

PI/汇报人：复旦大学附属肿瘤医院王碧芸

22. 长春瑞滨+伊尼妥单抗+吡咯替尼作为HER2阳性转移性乳腺癌 HER2阳性转移性乳腺癌二线及以上治疗的有效性和安全性

433P：Effectiveness and safety of vinorelbine + inetetamab + pyrotinib in ≥second-line treatment of HER2-positive metastatic breast cancer

PI/汇报人：福建省肿瘤医院吴凡

23. 伊尼妥单抗联合吡咯替尼和优替德隆治疗HER2阳性转移性乳腺癌 HER2阳性转移性乳腺癌的一项前瞻性研究（IPUtrial）的初步结果

436P：Preliminary results from a prospective study of inetetamab in combination with pyrotinib and utidelone for HER2-positive metastatic breast cancer (IPUtrial)

PI/汇报人：沈阳市第五人民医院曹辉

24. 以吡咯替尼为基础治疗曲妥珠单抗联合帕妥珠单抗经治的HER2阳性转移性乳腺癌 HER2阳性转移性乳腺癌的临床结局

453P：Clinical outcomes of Pyrotinib-based therapy after prior trastuzumab and pertuzumab in HER2-positive metastatic breast cancer

PI/汇报人：中国人民解放军总医院第五医学中心王涛

25. 建立HER2 阳性乳腺癌 HER2 阳性乳腺癌脑转移的预后风险模型和治疗方案

464P：Developing a Prognostic Risk Stratification Model and Treatment Options for HER2-Positive Breast Cancer Brain Metastasis

PI/汇报人：中国人民解放军总医院第五医学中心王涛

26. 口服选择性ER共价拮抗剂HRS8807（SERCA）治疗ER+/HER2-局部晚期（LA）或转移性（M）乳腺癌（BC）的Ⅰ期研究

868P：Phase 1 study of HRS8807, an oral selective ER covalent antagonist (SERCA), in ER+/HER2- locally advanced (LA) or metastatic (M) breast cancer (BC)

PI/汇报人：复旦大学附属肿瘤医院吴炅

宫颈癌

卡瑞利珠单抗联用法米替尼相关研究1项

27. 卡瑞利珠单抗联合法米替尼对比卡瑞利珠单抗单药或研究者选择化疗治疗复发转移性宫颈癌

LBA44：Camrelizumab plus famitinib versus camrelizumab alone and investigator's choice of chemotherapy in women with recurrent or metastatic cervical cancer

PI/汇报人：复旦大学附属肿瘤医院吴小华

肺癌

卡瑞利珠单抗、阿帕替尼相关共2项研究

28. 卡瑞利珠单抗联合阿帕替尼新辅助治疗可切除非小细胞肺癌患者：一项2期研究的1年结果更新

1296P：Neoadjuvant Camrelizumab and Apatinib in Patients with Resectable Non-Small-Cell Lung Cancer: One-Year Update From a Phase 2 Trial

PI/汇报人：中国医学科学院肿瘤医院高树庚

29. 脑部放疗联合卡瑞利珠单抗和含铂化疗一线治疗晚期NSCLC脑转移患者：一项多中心、开放标签、单臂2期研究

1439P：Brain radiotherapy combined with camrelizumab and platinum-based chemotherapy as first-line treatment foradvanced NSCLC with brain metastases: a multicenter, open-label, single-arm, phase 2 study

PI/汇报人：浙江省肿瘤医院范云

前列腺癌

瑞维鲁胺相关研究1项

30. CHART研究中接受瑞维鲁胺治疗的高瘤负荷、转移性激素敏感性前列腺癌患者前列腺特异性抗原深度下降与生存期之间的关联

1788P：Association between deep prostate-specific antigen decline and survival in patients with high-volume, metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial

PI/汇报人：复旦大学附属肿瘤医院叶定伟

肺外神经内分泌癌

卡瑞利珠单抗相关研究1项

31. 卡瑞利珠单抗联合EP/EC方案后序贯卡瑞利珠单抗联合阿帕替尼一线治疗晚期肺外神经内分泌癌：一项前瞻性、单臂、多中心临床研究

1205TiP：Camrelizumab combined with EP/EC chemotherapy followed by camrelizumab plus apatinib for first-line therapy of advanced extrapulmonary neuroendocrine carinoma: a prospective, single-arm, multicenter clinical study

PI/汇报人：华中科技大学同济医学院附属同济医院邱红

头颈鳞癌

卡瑞利珠单抗相关研究1项

32. 卡瑞利珠单抗联合多西他赛、顺铂和卡培他滨用于晚期下咽癌诱导治疗的抗肿瘤活性和安全性

934P：Antitumor activity and safety profile of camrelizumab plus docetaxel, cisplatin, and capecitabine for induction therapy in advanced stage hypopharyngeal carcinoma

PI/汇报人：复旦大学附属眼耳鼻喉科医院周梁

肉瘤

卡瑞利珠单抗、SHR-2554相关共2项研究

33. SHR-2554治疗晚期上皮样肉瘤的初步疗效和安全性：一项2期研究

1941P：Preliminary efficacy and safety of SHR-2554 in advanced epithelioid sarcoma: a Phase 2 trial

PI/汇报人：上海市第六人民医院胡海燕

34. 艾日布林联合安罗替尼和卡瑞利珠单抗治疗晚期或转移性腹膜后脂肪肉瘤（RLPS）或平滑肌肉瘤（RLMS）的疗效和安全性：一项单中心回顾性队列研究

1943P：Efficacy and safety of eribulin plus anlotinib and camrelizumab in advanced or metastatic retroperitoneal liposarcoma (RLPS) or leiomyosarcoma (RLMS): a single-center retrospective cohort study

PI/汇报人：北京大学肿瘤医院吴剑挥

黑色素瘤

SHR-1701相关研究1项

35. SHR-1701联合替莫唑胺治疗晚期黑色素瘤的II期临床研究

1110P：A phase II clinical trial of SHR-1701 combined with temozolomide for advanced melanoma

PI/汇报人：复旦大学附属肿瘤医院胡涂

本次ESMO大会，恒瑞医药将携13款抗肿瘤创新药的35项研究登上国际学术舞台，是国际肿瘤学术界对恒瑞医药抗肿瘤领域自主研发创新实力的认可，也是我国医药创新力量的一次展现。

作为创新型国际化制药企业，恒瑞医药多年来针对中国高发肿瘤领域持续推进创新研发。目前，公司已在中国获批上市自研创新药13款、引进创新药2款，其中肿瘤创新药达9款。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，服务健康中国，惠及全球患者。