2023-10-10
2023 ESMO前瞻︱恒瑞醫藥13款抗腫瘤創新藥的35項研究成果將亮相國際舞臺
2023年歐洲腫瘤(liu)內科學會(hui)(hui)（ESMO）大會(hui)(hui)將(jiang)于10月20日(ri)(ri)至24日(ri)(ri)（中歐夏令(ling)時(shi)間CEST）在(zai)西班(ban)牙馬德里召開。作(zuo)為(wei)全球最具影(ying)響力(li)的腫瘤(liu)學會(hui)(hui)議之一，ESMO官方近日(ri)(ri)公(gong)布了此次大會(hui)(hui)摘要(yao)題(ti)目，恒瑞醫(yi)藥(yao)共有13款抗腫瘤(liu)創新藥(yao)的35項(xiang)(xiang)(xiang)研究(jiu)成果入(ru)圍，其中2項(xiang)(xiang)(xiang)入(ru)選(xuan)(xuan)優(you)選(xuan)(xuan)口頭（Proffered Paper）報(bao)告(gao)，5項(xiang)(xiang)(xiang)研究(jiu)入(ru)選(xuan)(xuan)簡短口頭（Mini Oral）報(bao)告(gao)，28項(xiang)(xiang)(xiang)研究(jiu)接收為(wei)壁(bi)報(bao)，覆蓋(gai)消化道腫瘤(liu)、乳腺癌(ai)(ai)、宮頸癌(ai)(ai)、胰(yi)腺癌(ai)(ai)、肺癌(ai)(ai)、黑色素瘤(liu)、肉瘤(liu)、膽管癌(ai)(ai)等十余個(ge)領域。
實體瘤
SHR-1701、SHR-A2009、SHR-A1811、HRS-4642相關共4項研究
1、新型KRAS G12D抑制劑HRS-4642在KRAS G12D突變晚期(qi)實體(ti)瘤患者(zhe)中的首次人(ren)體(ti)1期(qi)研究（入選(xuan)優選(xuan)口頭(tou)報告）
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/匯報(bao)人：上海市肺科醫院 周(zhou)彩(cai)存
2. 靶向HER2-ADC SHR-A1811治療HER2表達/突變的晚(wan)期非乳(ru)腺(xian)的實(shi)體(ti)瘤（STs）：來(lai)自(zi)全球1期研(yan)究的結(jie)果(guo)
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/匯(hui)報人：中山大學孫(sun)逸仙(xian)紀(ji)念醫(yi)院 姚(yao)和瑞
3. 靶(ba)向HER3-ADC SHR-A2009在晚期實體瘤中(zhong)的(de)1期研(yan)究(jiu)
658MO：Phase 1 study of SHR-A2009, a HER3-targeted ADC, in advanced solid tumors
PI/匯報人：廣東(dong)省人民醫院(yuan)腫(zhong)瘤醫院(yuan) 周清
4. SHR-1701（一種(zhong)抗PD-L1/TGF-βRII雙抗藥物）聯合貝伐珠(zhu)單抗（BEV）治療晚期(qi)(qi)實體瘤(liu)患者(zhe)的1b/2期(qi)(qi)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/匯報人(ren)：中山大學腫(zhong)瘤(liu)醫(yi)院 徐瑞(rui)華
消化道腫瘤
卡瑞利珠單抗、阿帕替尼、SHR-A1811、SHR-1701相關共11項研究
5. 局(ju)部(bu)晚期直腸癌新輔助短程放(fang)療序貫(guan)卡(ka)瑞利珠單(dan)抗聯合化(hua)(hua)療與長程放(fang)化(hua)(hua)療序貫(guan)化(hua)(hua)療的比較：一項隨機III期研(yan)究（UNION）（入選(xuan)優選(xuan)口(kou)頭報(bao)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/匯報人：華中(zhong)科技(ji)大學(xue)同濟醫(yi)學(xue)院附屬(shu)協和醫(yi)院 張濤、陶(tao)凱雄
6. 局部晚期可切除胃或胃食管交界癌（G/GEJ）圍手(shou)術期卡(ka)利珠單抗聯合阿帕替尼和化療對(dui)比化療：隨機3期研究(jiu)（DRAGON IV）的首次(ci)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/匯報人：上(shang)海交通大學醫(yi)學院附屬(shu)瑞(rui)金醫(yi)院 朱正綱(gang) 李(li)琛
7. SHR-1701聯合(he)BP102和XELOX用于不可(ke)切除的(de)轉移性結直腸癌（mCRC）患(huan)者的(de)一線(xian)治療(liao)：來(lai)自(zi)2/3期研(yan)究數據(ju)
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/匯報人：中山(shan)大學腫瘤(liu)醫院 徐瑞華
8. 維(wei)莫非尼、西妥昔單(dan)抗(kang)聯合卡瑞利(li)珠單(dan)抗(kang)治療BRAF V600E突變/MSS轉移性(xing)結直腸(chang)癌的耐受(shou)性(xing)和(he)安全性(xing)
624P：Tolerability and Safety of Vemurafenib, Cetuximab Combined with Camrelizumab for BRAF V600E-mutated /MSS Metastatic Colorectal Cancer
PI/匯報人(ren)：四川大學華西醫院(yuan) 邱萌(meng)
9. 一(yi)項1b/2期開(kai)放標(biao)簽研究（NCT04073615）旨在評估阿(a)帕替尼聯合曲氟尿(niao)苷/替吡(bi)嘧(mi)啶治(zhi)療經治(zhi)轉移性結直腸癌患者(zhe)的安全(quan)性、耐受(shou)性和(he)療效(xiao)
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/匯報(bao)人(ren)：Vanderbilt University Medical Center Cathy Eng
10. SHR-A1811治療HER2+晚期胃癌(ai)（GC）或胃食管交界癌(ai)（GEJ）及結(jie)直腸癌(ai)（CRC）的1期研究(jiu)
684P：Phase 1 trial of SHR-A1811 in HER2-expressing advanced gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) and colorectal cancer (CRC)
PI/匯報(bao)人(ren)：復旦大學(xue)附屬腫瘤醫院 李進
11. 卡瑞利珠單抗聯合化療對比同步放(fang)化療作為可(ke)切除胸段(duan)食管鱗癌（REVO）的新輔助治(zhi)療：一項多中心、隨機、開放(fang)標簽、2期研究(jiu)
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/匯報人(ren)：福(fu)建(jian)省腫瘤醫院 柳碩巖(yan)
12. 卡瑞利珠單(dan)抗(kang)聯(lian)合化療(liao)新輔助治療(liao)術前(qian)可切除食管鱗癌(ai)（ESCC）患者的探索性臨床研(yan)究初步結果
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/匯(hui)報人：山東(dong)省腫瘤醫(yi)院 董印(yin)軍
13. 卡瑞利(li)珠單抗聯合多西他賽和卡鉑(bo)新輔助治療局部晚期食管鱗癌的臨床研究
1543P：Clinical study of camrelizumab combined with docetaxel and carboplatin in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma
PI/匯報人：河北醫(yi)科(ke)大(da)學(xue)第四醫(yi)院(yuan) 王(wang)瑞(rui)
14. 卡瑞利珠單抗聯合白蛋白紫杉醇和S-1作為晚期(qi)胃/胃食管交界(jie)癌的一(yi)線治療：一(yi)項II期(qi)臨床(chuang)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/匯報人(ren)：河(he)南(nan)省腫(zhong)瘤醫院 侯新(xin)芳
15. 卡瑞利珠(zhu)單(dan)抗(kang)聯(lian)合mFLOT方案在初始不可切(qie)除的(de)局(ju)部晚期(qi)或(huo)局(ju)限性轉(zhuan)移性胃或(huo)胃食(shi)管交界(jie)癌（GEJ）患者中的(de)轉(zhuan)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/匯報人(ren)：復旦大學附屬腫瘤(liu)醫院 耿其榮
肝膽胰腺腫瘤
氟唑帕利、阿得貝利單抗（SHR-1316）相關共2項研究
16. 阿得貝利單抗聯合IBI310治療一線治療失(shi)敗后的晚期肝內膽(dan)管癌患者的一項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/匯(hui)報(bao)人：復旦大學(xue)附屬中山醫院(yuan) 樊嘉(jia)
17. 氟唑帕(pa)利聯合(he)mFOLFIRINOX 后維持(chi)氟唑帕(pa)利一(yi)線治療不可切除(chu)的局部晚(wan)期或轉移性（LA/M）胰腺癌（PC）患者：一(yi)項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/匯(hui)報人(ren)：復旦(dan)大(da)學附屬(shu)腫瘤(liu)醫院(yuan) 虞先濬
乳腺癌
吡咯替尼、卡瑞利珠單抗、阿帕替尼、法米替尼、HRS8807相關共9項研究
18. 基于(yu)阿帕替尼的(de)治療方案(an)對于(yu)轉移性三陰性乳腺癌(ai)中臨床價值的(de)真(zhen)實(shi)世界研究
423P：A real-world study on the clinical value of apatinib-based regimens in metastatic triple-negative breast cancer
PI/匯報(bao)人：福(fu)建省腫(zhong)瘤醫院 黃(huang)偉(wei)煒
19. 吡咯替尼聯合卡培他(ta)濱(bin)治療曲妥珠單抗耐藥的(de)HER2陽(yang)性晚期(qi)乳腺(xian)癌(ai)：2期(qi)PICTURE研究的(de)最新生存結果
424P：Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer: updated survival results from the phase 2 PICTURE trial
PI/匯報人：復(fu)旦大學(xue)附屬腫瘤醫院 胡夕春
20. FUTURE-C-PLUS的(de)總生存報(bao)告(gao)：評估法米替尼(ni)聯合卡瑞(rui)利珠單抗(kang)加(jia)白蛋白紫杉醇(chun)晚期一(yi)線(xian)治(zhi)療免疫調節(jie)型三(san)陰性乳腺癌的(de)一(yi)項開放(fang)標簽、單臂(bei)、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/匯報人：復旦(dan)大學(xue)附屬腫瘤醫院 王(wang)中(zhong)華
21. 吡(bi)咯替(ti)尼(ni)聯合曲妥珠單抗對比帕(pa)妥珠單抗聯合曲妥珠單抗治療HER2陽性轉移性乳腺癌：一項多中(zhong)心、回顧性研究
427P：Pyrotinib Plus Trastuzumab versus Pertuzumab Plus Trastuzumab in Patients with HER2-Positive Metastatic Breast Cancer: A Multicenter, Retrospective Study
PI/匯(hui)報人(ren)：復旦大學附(fu)屬腫瘤醫院 王碧蕓
22. 長(chang)春瑞濱+伊尼妥單抗(kang)+吡咯替尼作為HER2陽性(xing)(xing)轉移性(xing)(xing)乳腺癌二線及以上(shang)治(zhi)療(liao)的有(you)效性(xing)(xing)和安全性(xing)(xing)
433P：Effectiveness and safety of vinorelbine + inetetamab + pyrotinib in ≥second-line treatment of HER2-positive metastatic breast cancer
PI/匯報人：福建省腫瘤(liu)醫院(yuan) 吳凡
23. 伊尼(ni)妥(tuo)單抗聯(lian)合吡咯替尼(ni)和優替德(de)隆治(zhi)療HER2陽性轉(zhuan)移(yi)性乳腺癌(ai)的一項前瞻性研(yan)究（IPUtrial）的初步(bu)結果
436P：Preliminary results from a prospective study of inetetamab in combination with pyrotinib and utidelone for HER2-positive metastatic breast cancer (IPUtrial)
PI/匯報(bao)人(ren)：沈陽市第五人(ren)民醫院(yuan) 曹輝
24. 以(yi)吡咯替尼為(wei)基礎治療曲妥(tuo)珠單(dan)抗聯合帕妥(tuo)珠單(dan)抗經(jing)治的(de)HER2陽性轉移性乳腺癌的(de)臨床結局
453P：Clinical outcomes of Pyrotinib-based therapy after prior trastuzumab and pertuzumab in HER2-positive metastatic breast cancer
PI/匯報人：中國(guo)人民解放軍總醫院第五醫學中心 王濤(tao)
25. 建(jian)立HER2 陽性乳腺癌腦轉移的預后(hou)風險模型和治療方案
464P：Developing a Prognostic Risk Stratification Model and Treatment Options for HER2-Positive Breast Cancer Brain Metastasis
PI/匯報人(ren)：中國(guo)人(ren)民解放軍總醫院第(di)五(wu)醫學中心(xin) 王濤
26. 口服選擇性ER共(gong)價(jia)拮(jie)抗劑HRS8807（SERCA）治(zhi)療ER+/HER2-局(ju)部晚期(qi)（LA）或轉移性（M）乳腺(xian)癌（BC）的Ⅰ期(qi)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/匯報人：復旦大學附屬腫瘤醫院 吳炅
宮頸癌
卡瑞利珠單抗聯用法米替尼相關研究1項
27. 卡瑞(rui)利珠單抗聯合法(fa)米替(ti)尼對比卡瑞(rui)利珠單抗單藥或研究者(zhe)選擇化療治療復發(fa)轉移性宮(gong)頸(jing)癌
LBA44：Camrelizumab plus famitinib versus camrelizumab alone and investigator's choice of chemotherapy in women with recurrent or metastatic cervical cancer
PI/匯(hui)報(bao)人(ren)：復旦(dan)大學附(fu)屬腫瘤醫院 吳小(xiao)華(hua)
肺癌
卡瑞利珠單抗、阿帕替尼相關共2項研究
28. 卡瑞利珠單(dan)抗聯合阿帕(pa)替尼新(xin)輔助治療可切(qie)除非小細胞(bao)肺癌患者(zhe)：一(yi)項2期研究(jiu)的1年結果更新(xin)
1296P：Neoadjuvant Camrelizumab and Apatinib in Patients with Resectable Non-Small-Cell Lung Cancer: One-Year Update From a Phase 2 Trial
PI/匯報人：中國(guo)醫學科(ke)學院腫瘤醫院 高樹庚
29. 腦(nao)(nao)部放(fang)療(liao)聯合卡瑞利珠單(dan)(dan)抗和含鉑化療(liao)一線治(zhi)療(liao)晚期NSCLC腦(nao)(nao)轉移患者：一項多中心、開放(fang)標簽、單(dan)(dan)臂2期研究(jiu)
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/匯報人：浙江省腫(zhong)瘤醫院 范云
前列腺癌
瑞維魯胺相關研究1項
30. CHART研究中接(jie)受(shou)瑞維(wei)魯胺治療(liao)的高瘤(liu)負荷(he)、轉移性(xing)激素敏感(gan)性(xing)前列(lie)腺癌(ai)患者(zhe)前列(lie)腺特異性(xing)抗(kang)原(yuan)深度下降與生存期之間的關聯
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/匯報(bao)人：復旦大學附屬(shu)腫瘤醫(yi)院 葉定(ding)偉
肺外神經內分泌癌
卡瑞利珠單抗相關研究1項
31. 卡(ka)瑞利(li)珠單(dan)抗(kang)聯合(he)EP/EC方(fang)案后序貫卡(ka)瑞利(li)珠單(dan)抗(kang)聯合(he)阿帕替尼一線治(zhi)療晚(wan)期肺外神經內分泌(mi)癌：一項前瞻性、單(dan)臂(bei)、多(duo)中心(xin)臨床研究(jiu)
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/匯(hui)報(bao)人：華中科(ke)技大(da)學同濟醫學院附屬同濟醫院 邱紅
頭頸鱗癌
卡瑞利珠單抗相關研究1項
32. 卡瑞利珠單抗聯(lian)合多(duo)西他賽、順鉑和卡培他濱(bin)用于(yu)晚(wan)期下咽癌誘(you)導治療的抗腫瘤活性和安全性
934P：Antitumor activity and safety profile of camrelizumab plus docetaxel, cisplatin, and capecitabine for induction therapy in advanced stage hypopharyngeal carcinoma
PI/匯報人：復旦大學附屬眼耳鼻喉(hou)科醫院 周梁
肉瘤
卡瑞利珠單抗、SHR-2554相關共2項研究
33. SHR-2554治療(liao)(liao)晚期上(shang)皮(pi)樣肉(rou)瘤的初步療(liao)(liao)效和安全性：一項(xiang)2期研究
1941P：Preliminary efficacy and safety of SHR-2554 in advanced epithelioid sarcoma: a Phase 2 trial
PI/匯報人(ren)：上海市第六人(ren)民醫(yi)院 胡海燕
34. 艾日(ri)布林聯合安羅替尼(ni)和(he)卡瑞利珠單(dan)抗治(zhi)療晚期(qi)或(huo)轉移性(xing)腹膜后脂肪(fang)肉(rou)瘤（RLPS）或(huo)平滑(hua)肌肉(rou)瘤（RLMS）的療效和(he)安全(quan)性(xing)：一(yi)項單(dan)中(zhong)心(xin)回顧性(xing)隊列研究
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/匯(hui)報人：北京大學腫(zhong)瘤醫院 吳劍揮
黑色素瘤
SHR-1701相關研究1項
35. SHR-1701聯(lian)合替莫唑胺治療晚期黑(hei)色(se)素瘤的II期臨(lin)床研究
1110P：A phase II clinical trial of SHR-1701 combined with temozolomide for advanced melanoma
PI/匯(hui)報人：復旦大學附屬腫(zhong)瘤醫(yi)院(yuan) 胡涂
本(ben)次ESMO大會，恒瑞醫藥(yao)將攜13款抗(kang)腫瘤創(chuang)新藥(yao)的(de)(de)35項研究登(deng)上國(guo)(guo)際學術舞臺，是國(guo)(guo)際腫瘤學術界(jie)對恒瑞醫藥(yao)抗(kang)腫瘤領域自主研發創(chuang)新實力(li)的(de)(de)認可，也是我國(guo)(guo)醫藥(yao)創(chuang)新力(li)量的(de)(de)一次展現(xian)。
作為創(chuang)新(xin)(xin)(xin)型國(guo)際化(hua)制藥(yao)企業，恒(heng)瑞(rui)醫藥(yao)多(duo)年來針對中(zhong)(zhong)國(guo)高發(fa)腫瘤領域(yu)持續推進創(chuang)新(xin)(xin)(xin)研發(fa)。目前，公司已在(zai)中(zhong)(zhong)國(guo)獲批上(shang)市自(zi)研創(chuang)新(xin)(xin)(xin)藥(yao)13款、引(yin)進創(chuang)新(xin)(xin)(xin)藥(yao)2款，其中(zhong)(zhong)腫瘤創(chuang)新(xin)(xin)(xin)藥(yao)達(da)9款。未來，恒(heng)瑞(rui)醫藥(yao)將繼續堅持“以患者(zhe)(zhe)為中(zhong)(zhong)心”的理(li)念(nian)，重創(chuang)新(xin)(xin)(xin)，強(qiang)研發(fa)，力爭(zheng)研制出更多(duo)更好的新(xin)(xin)(xin)藥(yao)，服(fu)務(wu)健康中(zhong)(zhong)國(guo)，惠及全(quan)球(qiu)患者(zhe)(zhe)。