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行业专题2023年10月18日2023年ESMO重点创新药进展跟踪文章摘要标题梳理丁丹(分析师)电话书编号:S0880514030001甘坛焕(分析师)电话书编号:S0880523080007唐玉青(研究助理)电话书编号:S088012307013301020102ESMO年会即将拉开帷幕,揭示创新药最新研究动态议日程已在官网公布,主要的汇报形式按其重要性由高到低依次排序为:重磅摘要(L密切关注本土创新药研究成果发布代表的新兴靶点相关的小分子靶向药或单克隆抗体的最新研发进展(百济神州、益方生物、加科斯等);(3)新一代生物技术平台相关的新药研发进展,主要包括双抗(康方生物、康宁杰瑞等)和ADC(科伦博泰、迈威生物等)。2小分子实体瘤Afirst-in-humanphase1studyofanovelKRASG12DinhibitorHRS-4642inpatientswithadvancedsolidtumorsharboringKRASG12Dmutation新型KRASG12D抑制剂HRS-4642在KRASG12D突变晚期实体瘤患者中的首次人体1期研究LBA33卡瑞利珠单抗单抗直肠癌Neoadjuvantshort-courseradiotherapyfollowedbycamrelizumabpluschemotherapyversuslong-coursechemoradiotherapyfollowedbychemotherapyinlocallyadvancedrectalcancer:a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(UNIONLBA25米替尼酸激酶单抗+小分子宫颈癌Camrelizumabplusfamitinibversuscamrelizumabaloneandinvestigator'schoiceofchemotherapyinwomenwithrecurrentormetastaticcervicalcancer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LBA44Perioperativecamrelizumab(C)combinedwithrivoceranib(R)andchemotherapy(chemo)versuschemoforlocallyadvancedresectablegastricorgastroesophagealjunction(G/GEJ)adenocarcinoma:thefirstinterimanalysisofarandomized,phase3trial(DRAGONIV)卡瑞利珠单抗+阿局部晚期可切除胃或胃食管交界癌(G/卡瑞利珠单抗+阿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年结果更新资料来源:2023ESMO国泰君安证券研究LBA。3ADC实体瘤TheHER2-targetingADCSHR-A1811inHER2-expressing/mutatedadvancednon-breatumors(STs):resultsfromtheglobalphase1study靶向HER2ADCSHRA1811治疗HER2表达/突变的晚期非乳腺的实体瘤究的结果656MOADCADC胃或胃食管交界癌实体瘤Phase1trialofSHR-A1811inHER2-expressingadvancedgastriccancer(GC)gastroesophagealjunctionadenocarcinoma(GEJ)andcolorectalcancer(CRC)SHR-A1811治疗HER2+晚期胃癌(GC)PhasePhase1studyofSHR-A2009,aHER3-tar684P658MO658MO双抗实体瘤bevacizumab(BEV)inpatientswithadvancedsolidtumors1b/2期研究结直肠癌SHR-1701incombinationwithBP102andXELOXasfirst-line(1L)treatmentforpatients(pts)withunresectablemetastaticcolorectalcancer(mCRC):datafromaphase2/3studySHR-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期研究数据611P资料来源:2023ESMO国泰君安证券研究4替雷利珠单抗单抗胃或胃食管交界癌TreatmentofAdvancedGastricorGastroesophagealJunctionAdenocarcinoma(GC/GEJC):FinalAnalysisResultsoftheRLBA80非小细胞肺癌替雷利珠单抗联合含铂双药化疗用于可切除NSCLC新辅助+辅助治疗的随机双盲II期临床研究的病理反应研究LBA58欧司珀利单抗+替雷利珠单抗+贝伐珠单抗单抗肝癌BAT1706(bevacizumabbiosimilar)versusTIS+BAT1706inpatients(pts)withadvancedhepatocellularcarcinom在晚期肝细胞癌(HCC)患者中比较欧司珀利单抗(0CI)+Tislelizumab(TIS)+BAT1706(贝伐珠单抗生物类似物)对比TIS+BAT1706的2期随机、开放标签研究945MO欧司珀利单抗+替雷利珠单抗patients(pts)withunresectable,locallyadvanced,recurrent/metastaticesophageal欧司珀利单抗+替雷利珠单抗AdvanTIG-202:PhaseIIrandomized,multicenter,open-labelstudyof替雷利珠单抗±欧司珀利单抗withoutociperlimab(OCI)替雷利珠单抗±欧司珀利单抗cervicalcancer(CC)替雷利珠单抗联合或不联合欧司珀利单抗用于既往经治的复发或转移性宫颈癌患者的期研究资料来源:2023ESMO国泰君安证券研究5ADC实体瘤Amulticenter,open-label,doseescalationandexpansionstudyofDP303cinpatientswithHER2-postivepre-treatedadvancedsolidtumors.DP303C在已经接受治疗的HER2阳性晚期实体瘤患者中的多中心、开放标签、剂量递增和扩展研究385MOSYHA1813小分子脑膜瘤AphaseIdose-expansioncohortofSYHA1813,avascularendothelialgrowthfactorreceptor(VEGFR)1-3/colony-stimulatingfactor1receptor(CSF1R)inhibitor,inpatients(pts)withrecurrent用于复发性脑膜瘤患者的期剂量扩展队列研究506MOADC实体瘤First-in-human/phaseItrialofHS-20089,aB7-H4ADC,inpatientswithadvancedsolidtumors.HS-20089(一种B7-H4ADC)在晚期实体瘤患者中的首次I期临床试验381MO阿美替尼小分子Aumolertinibplusapatinibversusaumolertinibasfirst-linetreatmentinpatientswithEGFREGFR突变非小细胞mutationpositivelocallyadvancedormetastatinon-smallcelllungcancer(NSCLC):arando肺癌multicenterstudyEGFR)突变阳性局部晚期或转移性非小细胞肺癌(NSCLC)患者的一线治疗:LBA69资料来源:2023ESMO国泰君安证券研究6安罗替尼安罗替尼+贝莫苏拜单抗安罗替尼+派安普利单抗(与康方合作)多靶点酪氨酸激酶小分子肝转移消化道肿瘤Anlotinibpluschemotherapyasfirst-linetherapyforgastrointestinaltumorpatientswithunresectablelivermetastasis:preliminaryresultsfromamulti-cohort,multi-centerphaseIItrial乳腺癌Phase2studyofanlotinibcombinedwithtaxanesandlobaplatinintheneoadjuvanttreatmentoftriple-negativebreastcancer:efficacy,safetyandbiomarkeranalysisfromtheneoALTALtrial安罗替尼联合紫杉类药物和洛铂新辅助治疗三阴性乳腺癌的II期研究:来自neoALTAL研究的疗效、安全性和生物标志物分析246P氨酸激酶单抗+小分子食管鳞癌UpdateresultsofanlotinibcombinedwithTQB2450(PD-L1blockade)asfirst-linetreatmentforadvancedesophagealsquamouscellcarcinoma(ESCC):asingle-arm,multicenter,open-label安罗替尼联合贝莫苏拜单抗一线治疗晚期食管鳞癌:一项单臂、多中心、开放性期研究的结果更新酸激酶宫颈癌Penpulimab+anlotinibpluschemo-lesstherapyinfirst-linetreatmentforpersistent,recurrent,ors方案为一线宫颈癌治疗提供安全有效新略,探索放疗经治患者安罗替尼联合metastaticcervicalcancer:asingle-arm,phaseⅡstudy(ALTN-s方案为一线宫颈癌治疗提供安全有效新略,探索放疗经治患者安罗替尼联合资料来源:2023ESMO国泰君安证券研究7安罗替尼+派安普Penpulimab+anlotinibpluschemo-lesstherapyinfirst-linetreatmentforpersistent,recurrent,ors方案为一线宫颈癌治疗提供安全有效新略,探索放疗经治患者安罗替尼联合metastaticcervicalcancer:asingle-arm,phaseⅡstudy(ALTN-s方案为一线宫颈癌治疗提供安全有效新略,探索放疗经治患者安罗替尼联合依沃西双抗非小细胞肺癌placebocombinedwithpemetrexedandcarboplatininpatadvancedormetastaticnon-squamousNSCLCwhohaveprogressionfollowingEGFR-TKItreatment依沃西或安慰剂联合培美曲塞和卡铂治疗经EGFRTKI治疗进展的EGFR突变、局晚期或转移性非鳞状NSCLC的患者的随机、双盲、多中心临床期试验卡度尼利双抗肝癌Theefficacyandsafetyofcadonilimabcombinedwithlenvatinibforfirst-linetreatmentofadvancedhepatocellularcarcinoma:AphaseIb/IIclinicaltrial卡度尼利联合仑伐替尼一线治疗晚期肝细胞癌的疗效和安全性:Ib/I期临床试验小分子结直肠癌SafetyandefficacyofD-1553incombinationwithcetuximabinKRASG12Cmutatedcolorectalcancer(CRC):aphaseIIstudyGarsorasib联合西妥昔单抗在KRASG12C突变结直肠癌(CRC)患者中的I期临床研究550O胰腺癌D-1553inpatientswithKRASG12CmutatedadvancedpancreaticGarsorasib在KRASG12c突变的晚期胰腺癌(pca)患者中的临床研究资料来源:2023ESMO国泰君安证券研究8ADC乳腺癌SKB264(MK-2870)inpreviouslytreatedhormonereceptor-positive(HR+)metastaticbreastcancer(mBC):resultsfromaphaseI/II,single-arm,baskettSKB264用于既往治疗的HR+/HER2-转移性乳腺癌的I/II期单臂篮式试验的结果380MO胶质瘤AphaseIIstudytoexploretheefficacyandsafetyofFCN-159inrecurrentorprogressivepediatriclow-gradeglioma(pLGG)withMAPKpathway-activated研究499OPreclinicalPreclinicalevaluationofHLX42,anovelEGFR-targetingADC,forcetuximaborTKIresistant西妥昔单抗、TKI抑cancer(cetuximab)或酪氨酸激酶抑制剂(TKI)的耐药问题683PADCADC实体瘤693P693P资料来源:2023ESMO国泰君安证券研究9格来雷塞+JAB-3312小分子实体瘤Glecirasib(KRASG12Cinhibitor)incombinationwithJAB-3312(SHP2inhibitor)inpatientswith格来雷塞(KRASG12C抑制剂)与JAB-3312(SHP2抑制剂)联合用于治疗KRASG12C突变的实体瘤患者653O特瑞普利单抗单抗小细胞肺癌淋巴瘤chemotherapyasafirst-linetherapyforpatientswithextensivestagesmallcelllungcancer(ES-疗的随机III期试验AdvancedRenal-CellCarcinoma(RCC):Ar一项随机、开放标签的Il期研究RENOTORCH研究:特瑞普利单抗联合阿昔替尼与舒尼替尼在晚期肾细胞癌(RCC)一线治疗中的比较Asingle-arm,multicenterclinicalstudyofradiotherapycombinedwithtoripalimabinstageI/IIextranodalNK/Tcelllymphoma放疗联合特瑞普利单抗治疗I/II期结外NK/T细胞淋巴瘤的单臂、多中心临床研究LBA93826O资料来源:2023ESMO国泰君安证券研究呋喹替尼小分子结直肠癌Updatedresultsfromthemulticenterphase2studyoffirst-linetherapyinadvancedmetastaticcolorectalcancer(mCRC)结果更新AphaseIIAphaseIIstudytoevaluatetheefficacyandsafetyoffruquintinibcombinedwithtislelizumabandHepaticarteryinfusionchemotherapy(HAIC)foradvancedcolorectalcancerlivermetastases(CRLM)评估呋喹替尼+替雷利珠单抗和肝动脉输注化疗(HAIC)治疗晚期结直肠癌肝转移(CRLM)疗效和安全性的期研究Stereotacticablativeradiotherapycombinedwithfruquintinibandtislelizumabinmetastaticcolorectalcancer:Preliminaryfindingsfromasingle-arm,prospectivephaseltrial(RIFLE)立体定向消融放射疗法+呋喹替尼+替雷利珠单抗治疗转移性结直肠癌:单臂前瞻性I期临床试验(RIFLE)的初步结果FirstFirstreportofthesafety/tolerabilityandpreliminaryantitumoractivityoffruquintinibpluscapecitabineversuscapecitabineasmaintenancetreatmentformetastaticcolorectalcancer:anopen_labelrandomizedphaselb/lIst612P637P637P638P639P639P资料来源:2023ESMO国泰君安证券研究小分子小分子小分子非小细胞肺癌FruquintinibcombinedwithsintilimabandchemotherapyasthefirstlinetreatmentinadvancednaiveEGFR-andALK-negati呋喹替尼+信迪利单抗+化疗作为EGFR和ALK阴性的非鳞状非小细胞肺癌(nsg-NSCLC)的一线治I期试验的结果更新胃或胃食管交界癌AdvancedGastricOrGastroesophagealJunction(GEJ)Adenocarcinoma:ResultsFromAMulticenter,SingleArmPh呋喹替尼+信迪利单抗治疗未愈或既往接受过治疗的晚期胃腺癌或胃食管交界处腺癌患者:一项多中心、单臂II期研究的结果24-monthfollow24-monthfollowupofdurvalumabandsavolitinibcombinationinMETdrivencleclearcellrenalcancerMET驱动的透明细胞肾癌和非透明细胞肾癌患者使用德瓦鲁单抗赛沃替尼的24个月随访结果索凡替尼小分子PamiparibcombinedwithSurufatinibasaneoadjuvanttherapyforadvancedovariancancerpatientsintheentirepopulation:preliminaryresultsofaprospectiveexploratory,single-armphase帕米帕利+索凡替尼作为晚期卵巢癌患者的新辅助治疗:一项前瞻性探索性单臂I期临床研究的初步资料来源:2023ESMO国泰君安证券研究恩维达恩维达+苏维西塔单抗单抗单抗晚期实体瘤PhaseIb/IItrialofenvafolimab,anovelantibody,pluslenvatinibinpatientswithselectedadvancedsolidtumors恩沃利单抗+仑伐替尼治疗晚期实体瘤:b/I期临床试验鼻咽癌肝癌肝癌结直肠癌Envafolimabpluschemoradiotherapyforlocallyadvancednasopharyngealcarcinoma(NPC),aprospective,single-armedphaseIItrial恩沃利单抗用于鼻咽癌的前瞻性II期临床最新数据CombinationCombinationtherapyofenvafolimabandsuvemcituginpatientswithhepatocellularcarcinoma(HCC):ResultsfromaphaseIIclinicaltrial恩沃利单抗苏维西塔单抗治疗肝癌期临床数据Combinationtherapyofenvafolimab,suvemcitug,andFmicrosatellitestable(MSS)ormismatch-repairproficient(pMMR)colorectalcancer:ResultsfromaCombinationCombinationtherapyofenvafolimabandsuvemcitugwithchemotherapyinpatientswithnon-smallcelllungcancer(NSCLC):ResultsfromaphaseIIclinicalt636P资料来源:2023ESMO国泰君安证券研究血管内皮抑制素小分子小分子小分子单抗小分子小细胞肺癌AntitumoractivityandsafetyprofileoftrilaciclibinChinesepatientswithextensive-stagesmallcelllungcancer(ES-SCLC)receivingchemotherapy(TRACES):曲拉西利小细胞肺癌期TRACES研究结果更新:改善化疗耐受,潜在生存获益化疗后骨髓抑制食管鳞癌食管鳞癌晚期恶性肿瘤晚期恶性肿瘤SupportivemeasurestocontrolmyelosuppressionandcostsforpatientswithSCLCwithlurbinectedin,CAVortopotecanwithorwithouttrilaciclib:Areviewonthebasisofclinicaltrials曲拉西利减少临床化疗骨髓抑制并节约治疗费用PhasePhaseIItrialofendostarincombinationwithconcurrentchemoradiotherapyinpatientswithlocallyadvancedsquamouscellcarcinomaofesophagus恩度联合同步放化疗治疗局部晚期食管鳞癌期研究数据SIM1811-03(SIM0235),ananti-tumornecrosisfacpatientswithadvancedsolidtumorand/orcutaneousTcelllymphomas(resultsfromanon-goingfirst-in-humanphaseItrialinChinaAAphaseIstudyofsafety,pharmacokinetics,andpharmacodynamicsofSCR-6920,aproteinargininemethyltransferase5(PRMT5)inhibitor,inpatientswithadvancedmalignanttumorsSCR6920用于晚期恶性肿瘤的临床期研究数据2024P696P675P资料来源:2023ESMO国泰君安证券研究PreliminaryefficacyandsafetyofKN046(abispecificanti-PD-L1/CTLA-4)inpatientswithmetastaticnon-smallcelllungcancerwhopreviouslytreatedwithimmunecheckpointinhibitor(s)KN046用于既往接受过免疫检查点抑制剂的转移性非小细胞肺癌患者的初步疗效和安全性结果UpdatedresultsoftheefficacyandsafetyofKN046(abispecificanti-PD-L1/CTLA-4)inpatients非小细胞肺癌withmetastaticnon-smallcelllungcancer(NSCLC)whofailed非小细胞肺癌Thepreliminarydatafromasingle-arm,open-label,multicentercombinedwithaxitinibasfirst-line(1L)treatmentforNSCLCKN046联合阿昔替尼一线治疗晚期非小细胞肺癌的单臂、开放标签、多中心I期研究数据首次披露胸腺癌KN046inpatientswiththymiccarcinoma:Aprospective,single-arm,multi-centre,phaseIIstudy2186P418PTwo-yearfollow-updataontheefficacyandsafetyofKN026,aHER2-targetedbispecificantibodycombinedwithdocetaxelasfirst-linetreatmentforHER2-positiverecurrent/metastaticbreast418PcancerKN026联合多西他赛一线治疗HER2阳性复发转移性乳腺癌的疗效和安全性两年随访KN026incombinationwithdocetaxelasneoadjuvanttreatmentforHER2+earlyor247Padvancedbreastcancer(BC):Asingle-arm,multicenter,phaseIIstudy247PKN026联合多西他赛用于HER2阳性早期或局部晚期乳腺癌的新辅助治疗:一项单臂、期研究资料来源:2023ESMO国泰君安证券研究奥雷巴替尼Bcl-2/Bcl-xlBcr-Abl小分子小分子非小细胞肺癌Updatedstudyresultsofpelcitoclax(APG-1252)combinedwithosimertinibinpatients(pts)withAPG-1252联合奥希替尼治疗携EGFR突变的非小细胞肺癌(NSCLC)患者的最新临床研究成果AntitumorAntitumoractivityofolverembatinib(HQP1351)inpatients(pts)withTK-Iresistantsuccinatedehydrogenase-(SDH-)deficientgastrointestinalstromaltumor(GIST)间质瘤(GIST)患者中的抗肿瘤活性ADC实体瘤PreliminaryresultsfromaphaseI/lIstudyof9MW2821,anantibodydrugconjugatetargetingNectin-4,inpatientswithadvancedsolidtumors.9MW2821(一种靶向Nectin-4的抗体药物结合物)在晚期实体瘤患者中的I/I期研究的初步结果659MO重组蛋白MW05,anovel,long-actingrecombinanthumanserumalbumin/humangranulocyte-colonyi)Iuprotein2075P资料来源:2023ESMO国泰君安证券研究恩沙替尼ALK小分子非小细胞肺癌EfficacyandsafetyofensartinibinALK-positivenon-smallcelllungcancerpatientswithbrainmetastases:Amulticenter,open-label,single-arm,phaseIIstudy在有脑转移瘤的ALK阳性非小细胞肺癌患者中评价恩沙替尼的疗效和安全性:一项多中心、开放标签、单臂I期研究ADC实体瘤DB-1305(aTrop-2targetedantibody-drug-conjugate(ADC)inpatients(pts)withadvancedsolidtumors:Preliminaryclinicalresultsfromthephase(Ph)1/2astudy689P舒格利单抗单抗胃或胃食管交界癌GEMSTONE-303:prespecifiedprogression-freesurvival(PFS)andoverallsurvianalysesofaphase3studyofsugemalimabpluschemotherapyvsplacebopluschemotherapyintreatment-naïveadvancedgastricorgastroesophagealjunction(G/GEJ)adenocarcinomaLBA79资料来源:2023ESMO国泰君安证券研究ADC非小细胞肺癌BL-B01D1,afirst-in-classEGFRxHER3bispecificantibody-drugconjugate,inpatientswithNon-SmalCellLungCancer.Updatedresultsfromfirst-in-humanphase1studyBL-B01D1(一种首创EGFRXHER3双特异性抗体-药物偶联物)用于非小细胞肺癌患者的最新人体期研究最新结果ADC实体瘤BL-M07D1,aHER2antibody-drugconjexpressingbreastcancerandothersolidtumorsBLM07D1:一种用于局部晚期或转移性表达HER2的乳腺癌和其他实体瘤患者的HER2抗体药物偶联物685PABSK-011小分子肝癌First-in-humanstudyofABSK-011,anovel,highlyselectivefibroblastgrowthfactorreceptor(FGFR)4inhibitorfortreatingadvancedhepatocellularcarcinoma(HCC)withFGF19overexpression(HCC)ABSK-043单抗实体瘤First-in-humandose-escalatingstudyofABSK043,anovelandoralsmall-moleculeinhibitorofPD-L1,inpatientswithadva资料来源:2023ESMO国泰君安证券研究双抗宫颈癌EffcacyandsafetyofQL1706pluspaclitaxelandcisplatin/carboplatin+/-bevacizumab(Bev)as1Ltreatmentinrecurrentormetastalticcervicalcancer(r/mCC):asingle-arm,multicenterphasellstudy.效和安全性:一项单臂、多中心U期研究小分子乳腺癌IN10018incombinationwithpcancer(PROC):Asingle-arm,AphaseIb/IIAphaseIb/IIstudyofandToripalimabinmetastatictriple-资料来源:2023ESMO国泰君安证券研究奥塞米单抗单抗食管胃癌FirstAdvancedG/GEJCancerwithCLOxaliplatin(CAPOX)for-OverallSurvivaldatafromStudyTranStar102-CohortCTranstar102cohortc研究:osemitamab(TST001)联合卡培他滨和奥沙利铂(CAPOX)一线治PharmacokineticsPharmacokinetics,PharmacodynamicsandExposureResponseAnalysesofOsemitamabinPatientswithLocallyAdvancedorMetastat在局部晚期或转移性实体瘤患者中的药代动力学、药效学和暴露反应分析ADC鼻咽癌头颈鳞癌AnovelEGFR-targetedantibody-drugconjugant(ADC)forrecurrent/metastaticnasopharyngealcarcinomaEfficacyandEfficacyandsafetyofanovelanti-EGFRADCMRG003inrecurrentormetastaticsquamcarcinomaoftheheadandneckpatients新型抗EGFRADCMRG003在头颈复发或转移性鳞状细胞癌患者中的疗效和安全性860MO资料来源:2023ESMO国泰君安证券研究毗罗西尼小分子乳腺癌Amulticenter,single-arm,open-labeltrialofbirociclib,aCDK4/6inhibitor,apatientswithrefractoryHR+/HER2-metastaticbre单臂、开放标签试验404P小分子单抗+小分子结直肠癌食管胃癌PhaseIb/IIstudyofompenaclid(RGX-202-01),afirst-in-classoralinhibitransporterSLC6A8,incombinationwithFOLFIRIandbevacizumab(BEV)inRASmutated(RASm)second-line(2L)advanced/metastaticcolorectalcancer(mCRC)ompenaclid(RGX-202-01)的Ib/II期研究:一种肌酸转运蛋白SLC6A8的FIC口服抑制剂与FOLFIRI和贝伐单抗(BEV联合用于RAS突变(RAsm二线治疗(2L)晚期/转移性结直肠癌PhaseIbdose-expansionstudyofociperinpatients(pts)withmetastaticoesophagealsquamouscellcarcinoma(ESCC)andoesophagealadenocarcinoma(EAC)646P资料来源:2023ESMO国泰君安证券研究小分子胆管癌实体瘤TinengotinibinPatientswithAdvanced,FibroblastGrRefractory/RelapsedCholangiocarcinomaTinengotinib用于治疗晚期成纤维细胞生长因子受体(FGFR)抑制剂难治性/PreliminaryPreliminaryEfficacywithAdvancedSolidTumors:ResultsfromaPhaseIb/IIStudyTinengotinib(TT-00420)单药治疗中国晚期实体瘤患者(pts)的初步疗效和安全性:Ib/II期研究结果670P670PSenaparib小分子EfficacyandSafetyofSenaparibasMaintenanceTreatmentinPatientswithNewlyDiagnosedAdvancedOvarianCancer(FLAMESStudy):ARandomizedcontrolled,Phase3Trial到完全缓解(CR)或部分缓解(PR)后Senaparib单药维持治疗FIGOIII-IV期卵巢癌患者的有效性和安全性LBA36小分子实体瘤patientswithadvancedsolidtumorsIMP7068(一种WEE1抑制剂)在晚期实体瘤患者中的I期、多中心、剂量递增和剂量扩展研究662MO资料来源:2023ESMO国泰君安证券研究单抗胃肠道间质瘤withadvancedgastrointestinalstromaltumors(GIST)双抗实体瘤CBP-1018,aBi-Ligand-DrugConjugatetreate1,Multi-Center,Open-LaCBP-1018双特异性配体偶联药物在晚期实体瘤患者的期多中心、开放标签、剂量爬坡和扩组研究结直肠癌AphaseIdoseescalationstudyofGCC19CART:AnovelCoupledCARtherapyforsubjectswithmetastaticcolorectalcancer642P资料来源:2023ESMO国泰君安证券研究Sotorasib小细胞肺癌结直肠癌Tarlatamabforpatients(pts)withpreviouslytreatedsmallcelllungcancer(SCLC):Primaryanalysisofthephase2DeLLphi-301studySotorasibSotorasibpluspanitumumabversusstandard-of-careforchemorefractoryKRASG12C-mutatedmetastaticcolorectalcancer(mCRC):CodeBreak300phase3studysotorasib联合帕尼单抗与化疗难治性KRASG12C突变转移性codeBreak300II期研究LBA92LBALBA10Sitravatinib小分子多激酶抑制剂非小细胞肺癌SAPPHIRE:sitravatinib联合Nivolumab与多西他赛治疗既往接受过治疗的晚期非鳞状非小细KRYSTAL-7:Efficacyandsafetyofadagrasibwithpembrolizumabinpatientswithtreatment-LBALBA63Adagrasib小分子非小细胞肺癌naïve,advancednon-smallcelllungca(NSCLC)患者的疗效和安全性LBA65资料来源:2023ESMO国泰君安证券研究LBA。实体瘤Vaccine(CARVac)BNT211-01:对采用自动化流程制造的CLDN6CAR-T细胞重复剂量递增研究的中期结果±()CLDN6编码CAR-T细胞扩增RNA疫苗()LBA35度伐利尤单抗单抗胃或胃食管交界癌可切除胃癌和胃食管交界癌(GC/GEJC)中durvalumab联合5氟尿LBA73奥希替尼EGFR小分子非小细胞肺癌FLAURA2:一线(1L)奥希替尼(OS)±化疗(CTX)治疗EGFR突变晚期NSCLC的安全性和中枢神经系统结果LBA68奥希替尼EGFR小分子非小细胞肺癌一项多中心开放标签随机II期研究:奥希替尼联合和不联合雷莫西尤单抗初始治疗EGFR突变的转移性NSCLC(RAMOSE试验中期分析)LBA71资料来源:2023ESMO国泰君安证券研究GSK单抗CT的II期随机双盲试验(PERLA)的总生存率LBA64ADC实体瘤Trastuzumabderuxtecan(T-DXd)forpretreatedpatients(pts)withHER2-expressingsolidtumors:德曲妥珠单抗deruxtecan(T-Dxd)用于治疗已接受过HER2表达实体瘤治疗的患者:来自LBA34ADC乳腺癌Datopotamabderuxtecan(Dato-DXd)vschemotherapyinpreviouslytreatedinoperableormetastatichormonereceptor-positive,HER2-negative(HR+/HEresultsfromtherandomisedPhase3TROPION-Breast01triLBA11ADC非小细胞肺癌Datopotamabderuxtecan(Dato-DXd)vsdocetaxelinpreviouslytreatedadvanced/metastatic(adv/met)non-smallcelllungcancer(NSCLC):resultsoftherandomizedphase3studyLBA12资料来源:2023ESMO国泰君安证券研究VedotinNectin-4ADCNectin-4ADCADC尿路上皮癌EV-302/KEYNOTE-A39:Open-LaLBA6纳武利尤单抗单抗非小细胞肺癌尿路上皮癌尿路上皮癌乳腺癌CheckMate77T:Phase3studycomparingneoadjuvantnivolumab(NIVO)pluschemotherapy(chemo)vsneoadjuvantplacebopluschemofollowedbysurgeryandadjuvantNIVOorplacebocheckMate77T:I期研究,比较新辅助纳武单抗(NIVO)联合化疗(化疗)与新辅助安慰剂联合NivolumabNivolumabplusgemcitabine-cisplatinversusgemcitabine-cisplatinaloneforpreviouslyuntreatedunresectableormetastaticurothelialcarcinoma:resultsfromthephase3CheckMate901trial纳武单抗联合吉西他滨顺铂与单用吉西他滨顺铂治疗既往未经治疗的不可切除或转移性尿路上皮癌Ⅲ期checkMate901试验的结果Arandomized,double-blindtrialofnivolumab(NIVO)vsplacebo(PBO)withneoadjuvantchemotherapy(NACT)followedbyadjuvantendocrinetherapy(ET)±NIVOinpatients(pts)withhigh-疗新辅助治疗序贯辅助内分泌治疗±纳武利尤单抗LBA1LBA7LBA20资料来源:2023ESMO国泰君安证券研究VedotinTFADCADC宫颈癌TisotumabVedotinvsInvestigator’sChoiceofChemotherapyin2Lor3LRecurrentoinnovaTV301/ENGOT-cx12/GOG-3057:Tisotumabvedotin与研究者选择的2L或3L复发或转移性宫颈癌化疗的全球、随机、开放标签期研究LBA9双抗非小细胞肺癌amivantamab联合化疗与化疗作为EGFR外显子20插入突变的晚期非小细胞肺癌(NSCLC)-线治疗的对比:来自PAPILLON(一项随机Il期全球研究)的初步结果LBA5LBALBA14AmivantamabPlusCheChemotherapyinEGFR-mamivantamab联合化疗(联合或不联合Lazertinib)与奥西替尼进展后EGFR突变晚期NSCLCLBA15阿来替尼ALK小分子非小细胞肺癌ALINA:efficacyandsafetyofadjuvantalectinibversuschemotherapyinpatientswithearly-stageALK+non-smallcelllungcancer(NSCLC)Event-freesurvival(EFS)analysisofneoadjuvanttaxane/carboplatinwithorwithoutatezolizumabfollowedbyanadjuvantanthracyclineregimeninhigh-risktriplenegativebreastLBA2阿替利珠单抗单抗乳腺癌NeoTRIPMichelangelo随机研究的EFS分析:新辅助紫杉烷/卡铂±阿替利珠单抗序贯蒽环辅助治疗高危三阴性乳腺癌(TNBC)LBA19塞普替尼小分子甲状腺髓样癌Rand
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