ESMO 2022會議數(shù)據(jù)分析報(bào)告：中國企業(yè)全球創(chuàng)新前沿

證券研究報(bào)告

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2022年

09月

30日中國企業(yè)穩(wěn)步向全球創(chuàng)新前沿邁進(jìn)——ESMO

2022會議數(shù)據(jù)分析行業(yè)研究

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行業(yè)投資策略醫(yī)藥生物投資評級：超配（維持評級）報(bào)告摘要：ESMO2022會議數(shù)據(jù)分析?

ESMO年會

9月舉行，創(chuàng)新藥數(shù)據(jù)發(fā)布值得關(guān)注。ESMO（EuropeanSocietyforMedicalOncology）即歐洲腫瘤學(xué)會，成立于

1975年，是在腫瘤學(xué)領(lǐng)域國際領(lǐng)先的組織。ESMO舉辦的年會每年有超過

2.5萬名專業(yè)的會員參加，各領(lǐng)域的專家在會議上展示腫瘤學(xué)的基礎(chǔ)研究、轉(zhuǎn)化醫(yī)學(xué)、臨床研究等的最新進(jìn)展。今年的

ESMO年會在

9月份以線上和線下同步的方式舉行，中國企業(yè)的創(chuàng)新藥數(shù)據(jù)發(fā)布以及海外前沿分子的數(shù)據(jù)讀出值得關(guān)注。重磅產(chǎn)品的臨床進(jìn)度以及數(shù)據(jù)讀出是決定創(chuàng)新藥公司投資價(jià)值的重要因素之一，而一些全球領(lǐng)先藥物的數(shù)據(jù)發(fā)布也將影響其所在領(lǐng)域/藥物形態(tài)/靶點(diǎn)的開發(fā)價(jià)值和后續(xù)同類藥物開發(fā)策略的制定。?

中國企業(yè)重點(diǎn)品種亮點(diǎn)頗多。包括恒瑞醫(yī)藥、百濟(jì)神州、信達(dá)生物、康寧杰瑞等十余家中國創(chuàng)新藥公司在此次

ESMO會議上發(fā)布數(shù)據(jù)：

恒瑞醫(yī)藥：1）“雙艾”一線治療

HCC的全球多中心

3期臨床終點(diǎn)陽性數(shù)據(jù)讀出；2）達(dá)爾西利針對

HR+/HER2-mBC一線

PFS陽性數(shù)據(jù)讀出，二線延長隨訪數(shù)據(jù)更新；3）吡咯替尼一線治療

HER2+mBC達(dá)到主要臨床終點(diǎn)。

百濟(jì)神州：替雷利珠單抗單藥一線治療

HCC，頭對頭索拉非尼達(dá)到非劣效的預(yù)設(shè)臨床終點(diǎn)。

信達(dá)生物：1）信迪利單抗±貝伐珠單抗+化療治療

nsNSCLCEGFRmTKI進(jìn)展患者更新優(yōu)效數(shù)據(jù)；2）信迪利單抗+安羅替尼“免化療”一線治療

NSCLC的

ph2數(shù)據(jù)讀出。

康寧杰瑞：1）KN046讀出了

NSCLC1L/NSCLC2L/NSCLCEGFRmTKI進(jìn)展等多項(xiàng)

ph2數(shù)據(jù)；2）KN046+KN026一線治療

GC的

ph2數(shù)據(jù)讀出。?

投資建議。隨著多年的研發(fā)投入和積累，國產(chǎn)創(chuàng)新藥越來越多地在全球頂尖的學(xué)術(shù)會議中嶄露頭角，一些具備差異化創(chuàng)新特質(zhì)并且臨床進(jìn)度全球領(lǐng)先的分子未來有望在廣闊的全球市場實(shí)現(xiàn)商業(yè)化價(jià)值。國內(nèi)市場上，大藥企存量仿制藥業(yè)務(wù)受到集采的影響逐漸減弱，創(chuàng)新藥營收占比不斷提升，業(yè)績增速將持續(xù)回升；Biotech隨著重磅產(chǎn)品紛紛實(shí)現(xiàn)商業(yè)化，初步具備造血能力并持續(xù)推進(jìn)管線的研發(fā)。建議買入：恒瑞醫(yī)藥、康方生物、康諾亞、康寧杰瑞制藥，并關(guān)注：百濟(jì)神州、信達(dá)生物、君實(shí)生物、諾誠健華。?

風(fēng)險(xiǎn)提示：研發(fā)進(jìn)度不及預(yù)期的風(fēng)險(xiǎn)、監(jiān)管政策調(diào)整的風(fēng)險(xiǎn)、醫(yī)保降價(jià)超預(yù)期的風(fēng)險(xiǎn)、商業(yè)化進(jìn)度不及預(yù)期的風(fēng)險(xiǎn)目錄010203中國企業(yè)

ESMO壁報(bào)一覽重點(diǎn)品種臨床數(shù)據(jù)分析其他相關(guān)研究數(shù)據(jù)更新3恒瑞醫(yī)藥：卡瑞利珠單抗展示肝癌一線及多項(xiàng)輔助/新輔助數(shù)據(jù)表：恒瑞醫(yī)藥

ESMO展示壁報(bào)（卡瑞利珠單抗）分子方案適應(yīng)癥臨床

標(biāo)題編號Camrelizumab(C)plusrivoceranib(R)vs.sorafenib(S)asfirst-linetherapyforunresectablehepatocellularcarcinoma(uHCC):Arandomized,

LBA35phaseIIItrial+阿帕替尼HCC1Lph3NACAPT:Amulticenterrandomizedcontrolledtrialofperioperativeversuspostoperativecamrelizumabplusapatinibforresectablehepatocellular

712Pcarcinoma+阿帕替尼+阿帕替尼+阿帕替尼HCC圍手術(shù)期HCC輔助Anti-PD-1antibodySHR-1210combinedwithapatinibasadjuvanttreatmentinpatientswithhepatocellularcarcinomaathighriskofrecurrence

724Pafterradicalresection:Preliminaryresultsfromamulticenter,randomized,controlledphaseIItrialph2ph2ph2ph2ph2Camrelizumabplusapatinibinpatientswithrecurrentormetastaticnasopharyngealcarcinomafailingfirst-linetherapy:Anopen-label,single-arm,phaseIIstudyNPC2L663P1250P726P+阿帕替尼+化療CamrelizumabplusapatinibcombinedwithPOFinpatientswithuntreatedadvancedgastriccancer(UAGC):Asingle-center,open-label,single-arm,phaseIItrial(SYLT-017)GC1L+侖伐替尼+HAICCamrelizumabcombinedwithlenvatinibandRALOX-HAICforhepatocellularcarcinoma(HCC)inBCLCstageBandC:Aprospective,single-arm,phaseIItrial(CalErastudy)HCCCamrelizumabplusconcurrentchemoradiotherapyforlocallyadvancedcervicalcancer:Preliminaryresultsofasingle-arm,open-label,phaseII

562Ptrial+cCRTCC局部晚期

鞏固治療卡瑞利珠單抗Efficacyandsafetyofconsolidativecamrelizumabfollowingdefinitiveconcurrentchemoradiotherapyinpatientswithlocallyadvancedesophagealsquamouscellcancer+cCRT+化療+化療+化療+化療ESCC局部晚期

鞏固治療TNBC新輔助NA1262TiPph2ph2ph2ph2PhaseIIstudyofcamrelizumabpluschemotherapyasneoadjuvanttherapyinpatientswithearlytriple-negativebreastcancer170P942PCamrelizumabcombinedwithalbuminpaclitaxelandplatinuminperioperativetreatmentofresectablesquamouscelllungcancer:Asingle-arm,open-label,phaseIIclinicaltrialsqLC圍手術(shù)期CC局部晚期

新輔助UC≥2LNeoadjuvantcamrelizumabpluschemotherapyinpatientswithlocallyadvancedcervicalcancer(NACI):Aprospective,single-arm,phaseIItrial

560PCamrelizumabplusnab-paclitaxelinplatinum-resistantpatientswithunresectablelocallyadvancedormetastaticurothelialcarcinoma:Amulticentre,single-arm,phaseIIstudy1744PThreecoursesofneoadjuvantcamrelizumabcombinedwithchemotherapyinlocallyadvancedesophagealsquamouscellcarcinoma(ESCC):AprospectivephaseIIclinicaltrial+化療+化療+化療ESCC局部晚期

新輔助ESCC局部晚期

新輔助ESCC局部晚期

新輔助ph2NA1256P1234P1225PNeoadjuvantcamrelizumabplusdocetaxelandcarboplatininlocallyadvancedesophagealsquamouscellcarcinoma(ESCC):AprospectivestudyNeoadjuvanttherapyofcamrelizumabcombinedwithchemotherapyinpatients(pts)withresectableesophagealsquamouscellcancer(ESCC):PreliminaryresultsofapreoperativephaseexploratoryclinicaltrialNAEfficacyandsafetyofcamrelizumabcombinedwithFLOTversusFLOTaloneasneoadjuvanttherapyinpatientswithresectablelocallyadvancedgastricandgastroesophagealjunctionadenocarcinomawhoreceivedD2radicalgastrectomy+化療GC/GEJ局部晚期

新輔助NA1220P資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理恒瑞醫(yī)藥：吡咯替尼、達(dá)爾西利一線數(shù)據(jù)讀出表：恒瑞醫(yī)藥

ESMO

展示壁報(bào)（其他）分子方案適應(yīng)癥臨床

標(biāo)題編號阿帕替尼+化療mBCHER2-2/3Lph2

ApatinibcombinedwithchemotherapyversussinglechemotherapyinadvancedHER-2-negativebreastcancer:

247PArandomized,controlled,open-labelphaseIIstudyApatinibplustoripalima(anti-PD1therapy,JS001)foradvancedGC/EGJCpatients:ResultsfromapilotphaseIIstudy+特瑞普利單抗

GC2Lph21247P+化療GC1Lph1

ApatinibplusPOF(paclitaxelplusFOLFOX)inpatients(pts)withtreatment-na?veadvancedgastriccancer

1257P(TNAGC):UpdatefromthephaseIstudy(SYLT007)PyrotiniborplaceboincombinationwithtrastuzumabanddocetaxelforHER2-positivemetastaticbreast吡咯替尼達(dá)爾西利+曲妥珠+化療+化療mBCHER2+1Lph3ph2ph3ph3ph2LBA19cancer(PHILA):ArandomizedphaseIIItrialPyrotinibincombinationwithdocetaxelasfirst-linetreatmentforHER2-positivemetastaticbreastcancer(PANDORA):Asingle-arm,multicenterphaseIItrialmBCHER2+1L239P+來曲唑/阿那曲唑Dalpiciclibplusletrozoleoranastrozoleasfirst-linetreatmentforHR+/HER2-advancedbreastcancer(DAWNA-2):AphaseIIItrialmBCHR+/HER2-1LmBCHR+/HER2-2LLBA16229PDalpiciclibplusfulvestrantinHR+/HER2?

advancedbreastcancer(ABC):UpdatedanalysisfromthephaseIIIDAWNA-1trial+氟維司群單藥頭頸部黏膜黑色素瘤CDK4+≥2LPhaseIItrialofthecyclindependentkinase4/6inhibitorSHR6390inpatientswithadvancedheadandneckmucosalmelanomaharboringCDK4amplification880P氟唑帕利+替莫唑胺原發(fā)性膠質(zhì)母細(xì)胞瘤實(shí)體瘤ph2

PhaseIIstudyonthesafetyandefficacyoffluzoparibandtemozolomideinprimaryglioblastomaSafety,tolerability,pharmacokinetics,pharmacodynamicsandpreliminaryanti-tumoractivityofadebrelimab:AphaseItrial313TiP744P阿得貝利單抗

單藥ph1HR070803plus5-FU/LVversusplaceboplus5-FU/LVinsecond-linetherapyforgemcitabine-refractoryph3

locallyadvancedormetastaticpancreaticcancer:Amulticentered,randomized,double-blind,parallel-controlledphaseIIItrial(HR-IRI-APC)HR070803+5-FU/LVmPC2LLBA61資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理百濟(jì)神州：替雷利珠單抗展示多項(xiàng)聯(lián)用數(shù)據(jù)表：百濟(jì)神州

ESMO展示壁報(bào)分子方案適應(yīng)癥臨床

標(biāo)題編號FinalanalysisofRATIONALE-301:Randomized,phaseIIIstudyoftislelizumabversussorafenibasfirst-linetreatmentforunresectablehepatocellularcarcinoma替雷利珠單抗

單藥HCC1Lph3ph3LBA36PhaseIIIstudyoftislelizumab(TIS)withsitravatinibversuschemotherapy(chemo)inpatientswithlocallyadvanced/metastaticnon-smallcelllungcancer(NSCLC)previouslytreatedwithchemoandananti-1187TiPprogrammedcelldeathprotein1/ligand1(PD-[L]1)antibody+sitravatinib

NSCLCPD-1進(jìn)展Tislelizumab(TIS)versusdocetaxel(TAX)assecond-orthird-linetherapyinpreviouslytreatedpatients(pts)withlocallyadvancednon-smallcelllungcancer(NSCLC):Asianversusnon-Asiansubgroupanalysis

1031PoftheRATIONALE-303study單藥NSCLC2/3Lph3ph2PhaseIIstudyoftranshepaticarterychemoembolization(TACE)combinedwithtislelizumab(TIS)andlenvatinib(LEN)inpatientswithunresectablehepatocellularcarcinoma(uHCC)+侖伐替尼+TACE

HCC717P65PAsingle-arm,open-label,phaseIIstudyoftislelizumabcombinedwithlenvatinibandGemoxregimenforconversiontherapyofpotentiallyresectablelocallyadvancedbiliarytractcancers+侖伐替尼+化療

BTC局部晚期

降期療法

ph2Neoadjuvanttislelizumabforresectablerecurrenthepatocellularcarcinoma:Anon-randomizedcontrol,phaseIItrial(TALENT)±侖伐替尼+安羅替尼+放化療HCC可切除

新輔助ph2ph2710P564P447TiPEfficacyandsafetyoftislelizumabplusanlotinibinthetreatmentofcervicalcancerresistanttostandardtherapy:Aprospective,single-arm,openlabelledphaseIIclinicaltrialCC2LNeoadjuvantlong-coursechemoradiationplustislelizumab(anti-PD1)forMMR-status-unscreenedlocallyadvancedrectalcancer:StudyprotocolforaphaseII,3-arm,randomizedtrial局部晚期直腸癌

新輔助

ph2AdvanTIG-205:PhaseIItrialofociperlimab(OCI)+tislelizumab(TIS)+chemotherapy(chemo)infirst+替雷利珠單抗+化療ociperlimabNSCLC1Lph2line(1L)treatmentofpatients(pts)withlocallyadvanced(LA),unresectable,ormetastaticnon-small

1194TiPcelllungcancer(mNSCLC)AdvanTIG-105:PhaseIbdose-expansionstudyofociperlimab(OCI)+tislelizumab(TIS)withchemotherapyph1b

(chemo)inpatients(pts)withmetastaticsquamous(sq)andnon-squamous(non-sq)non-smallcelllungcancer(NSCLC)+替雷利珠單抗+化療NSCLC1L實(shí)體瘤1017P460MO1213PPreliminaryresultsfromaphaseIstudyusingthebispecific,humanepidermalgrowthfactor2(HER2)-targetingantibody-drugconjugate(ADC)zanidatamabzovodotin(ZW49)insolidcancersZW49單藥ph1+替雷利珠單抗+化療DKN-01andtislelizumab+chemotherapyasfirst-line(1L)investigationaltherapyinadvancedph2a

gastroesophagealadenocarcinoma(GEA):DisTinGuishtrialDKN01GC/GEJ1L資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理正大天晴：安羅替尼展示多項(xiàng)聯(lián)用數(shù)據(jù)表：正大天晴

ESMO

展示壁報(bào)分子方案適應(yīng)癥臨床

標(biāo)題Sintilimabplusanlotinibversusplatinum-basedchemotherapyasfirst-linetherapyinmetastaticNSCLC(SUNRISE):Anopenlabel,multi-center,randomized,phaseIIstudy編號安羅替尼

+信迪利單抗NSCLC1Lph2LBA57+派安普利單抗

胸膜間皮瘤和胸腺癌

ph2≥2LAnalysisofpenpulimabplusanlotinibinpleuralmesotheliomaorthymiccarcinomapatientswhohavereceivedatleast

1632PonelineofchemotherapyALTN-AK105-II-02cohort4:AphaseIIstudyofpenpulimabplusanlotinibinpatients(pts)withpreviouslytreatedlocallyadvancedormetastaticurothelialcarcinoma(UC)+派安普利單抗

mUC≥2Lph21743PPhaseI/IIstudytoevaluatepenpulimabcombinedwithanlotinibandepirubicininthefirst-linetreatmentofsoftph1/2

tissuesarcoma:PhaseIdoseescalationresults+派安普利單抗

軟組織肉瘤

1L+替雷利珠單抗

CC2L1498Pph2Efficacyandsafetyoftislelizumabplusanlotinibinthetreatmentofcervicalcancerresistanttostandardtherapy:

564PAprospective,single-arm,openlabelledphaseIIclinicaltrial未分化多形性肉瘤1LPreliminaryanalysisofasingle-arm,multi-centerstudyofanlotinibcombinedwithtoripalimabinfirst-linetreatmentofunresectableormetastaticundifferentiatedpleomorphicsarcoma+特瑞普利單抗+化療ph2ph2ph21501P1030P1036P1252PAnlotinibplusdocetaxelinthetreatmentofnon-smallcelllungcancer(NSCLC)afterfailureofpreviousimmunecheckpointinhibitors(ICIs)therapy:UpdatedresultsfromapooledanalysisoftwophaseIItrialsNSCLCICI進(jìn)展Anlotinibplusdocetaxelvs.docetaxelas2nd-linetreatmentofadvancednon-smallcelllungcancer(NSCLC):UpdatedresultsfromALTER-L016+化療NSCLC2LUpdateresultsofanlotinibcombinedwithnab-paclitaxelandcisplatinasneoadjuvanttreatmentforesophagealsquamouscellcarcinoma(ESCC):Asingle-arm,open-labelphaseⅡ

clinicaltrial+白紫+順鉑+艾日布林ESCC新輔助ph2ph2mBCHER2-≥2LEribulincombinedwithanlotinibforpatientswithHER2-negativemetastaticbreastcancer:Asingle-arm,multicenter,

244PphaseIIstudy單藥復(fù)發(fā)高級別膠質(zhì)瘤

ph2AphaseIIstudyofanlotinibinthetreatmentofrecurrenthigh-gradeglioma:Updatedresults304P±PD1單抗/化療

NSCLC2LNANAEfficacyandsafetyofanlotinibmonotherapyorcombinationtherapyassecond-linetherapyinEGFR-wild-typenon-small1004Pcelllungcancer(NSCLC)patientsReal-worldefficacyandsafetyofanlotinibincombinationwithPD-1/PD-L1inhibitorsasfirst-lineorsecond-linetreatmentinadvancednon-smallcelllungcancer+PD1單抗NSCLC1/2L1119P402PUpdatedresultsfromthemulticenterphaseII,ALTER-C001trial:EfficacyandsafetyofanlotinibplusXELOXregimenasfirst-linetreatmentfollowedbymaintenancemonotherapyofanlotinibforpatientswithmCRC+化療mCRC1LNATQB2450

+安羅替尼子宮內(nèi)膜癌

2/3Lph2TQB2450injectioncombinedwithanlotinibhydrochloridecapsuleinthetreatmentofadvanced,recurrentormetastatic

555Pendometrialcancer:Amulticohort,openlabel,multicenterphaseIIclinicaltrial-TheTQB2450-II-08trial資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理信達(dá)&君實(shí)：PD1

單抗多項(xiàng)數(shù)據(jù)讀出表：信達(dá)生物、君實(shí)生物

ESMO

展示壁報(bào)分子方案適應(yīng)癥臨床

標(biāo)題SintilimabwithorwithoutIBI305pluschemotherapyinpatientswithEGFRmutatednon-squamousnon-smallcell編號信迪利單抗±貝伐珠單抗+化

nsNSCLCEGFR-TKI進(jìn)展

ph3療lungcancer(EGFRmnsqNSCLC)whoprogressedonEGFRtyrosine-kinaseinhibitors(TKIs)therapy:SecondinterimLBA58analysisofphaseIIIORIENT-31studySintilimabplusanlotinibversusplatinum-basedchemotherapyasfirst-linetherapyinmetastaticNSCLC(SUNRISE):Anopenlabel,multi-center,randomized,phaseIIstudy+安羅替尼NSCLC1Lph2ph2ph2ph2NALBA57711PSintilimabcombinedwithbevacizumabbiosimilarasaconversiontherapyinpotentiallyresectableintermediatestagehepatocellularcarcinoma(HCC):AphaseIItrial+貝伐珠單抗+貝伐珠單抗+呋喹替尼HCCStageB轉(zhuǎn)化療法卵巢透明細(xì)胞瘤

≥2LmCRC≥3LPreliminaryresultsofsintilimab(Sin)+bevacizumab(Bev)inrecurrent/persistentovarianclearcellcarcinoma(INOVA):Amulticenter,single-arm,phaseIItrial522MO423PFruquintinibplussintilimabinrefractoryrepair-proficient(pMMR)/microsatellitestable(MSS)metastaticcolorectalcancer(mCRC):PreliminaryclinicalresultsandbiomarkeranalysesfromaphaseIIstudy+索凡替尼+伊匹木單抗SurufatinibcombinedwithsintilimabandIBI310inthetreatmentofhigh-gradeadvanced-neuroendocrineneoplasm:Asinglearm,open-label,multicenterstudy神經(jīng)內(nèi)分泌瘤499TiP955PUpdatedevent-freesurvivalofneoadjuvanttoripalimabwithchemotherapyforresectablestageIIINSCLC(NeoTAP01study)特瑞普利單抗

+化療+阿帕替尼NSCLCstage3新輔助GC2Lph2ph2ph2ph2ph2ph2ph2Apatinibplustoripalima(anti-PD1therapy,JS001)foradvancedGC/EGJCpatients:Resultsfromapilotphase

1247PIIstudyAsingle-arm,phaseIIclinicalstudyofimatinibmesylate/toripalimabcomboinpatients(pts)withadvanced

815Pmelanomaharboringc-Kitmutationoramplification+伊馬替尼+安羅替尼MLNc-Kit+1/2L未分化多形性肉瘤

1LPreliminaryanalysisofasingle-arm,multi-centerstudyofanlotinibcombinedwithtoripalimabinfirst-line1501P

treatment

of

unresectable

or

metastatic

undifferentiated

pleomorphic

sarcomaAphaseIItrialofhepaticarterialinfusionchemotherapyandbevacizumabincombinationwithtoripalimabforadvancedbiliarytractcancers:Interimreport+貝伐珠單抗+HAICBTC1L60PNeoadjuvantconcurrentchemoradiotherapycombinedwithimmunotherapyinthetreatmentofadenocarcinomaoftheoesophagogastricjunction:AphaseIIstudy+cCRTGC局部晚期

新輔助黏膜黑色素瘤

新輔助1215P796PNeoadjuvanttoripalimabplusaxitinibinpatients(pts)withresectablemucosalmelanoma(MuM):Updatedfindingsofasingle-arm,phaseIItrial+阿昔替尼資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理其他國產(chǎn)創(chuàng)新藥

ESMO展示壁報(bào)（1）表：其他國產(chǎn)創(chuàng)新藥

ESMO展示壁報(bào)（1）公司分子方案適應(yīng)癥臨床

標(biāo)題編號NSCLCEGFR-TKI進(jìn)展AphaseIIstudyofKN046(abispecificanti-PD-L1/CTLA-4)inpatientswithmetastaticnon-smallcelllungcancer(NSCLC)whofailedpriorEFGR-TKIs康寧杰瑞

KN046KN046+化療ph2ph2ph21034PAphaseIIstudyofKN046(abispecificanti-PD-L1/CTLA-4)inpatientswithmetastaticnon-smallcelllungcancer(NSCLC)whofailedfirstlinetreatment單藥NSCLC2LNSCLC1L1022P1029PTwo-yearfollow-upfromKN046incombinationwithplatinumdoubletchemotherapyasfirst-line(1L)treatmentforNSCLC:Anopen-label,multi-centerphaseIItrialKN046+化療ThepreliminaryefficacyandsafetyofKN026combinedwithKN046treatmentinHER2-GC/GEJHER2+1Lph2

positivelocallyadvancedunresectableormetastaticgastric/gastroesophagealjunctioncancerwithoutpriorsystemictreatmentinaphaseIIstudyKN026+KN0461210PLBA25FRESCO-2:AglobalphaseIIImultiregionalclinicaltrial(MRCT)evaluatingtheph3

efficacyandsafetyoffruquintinibinpatientswithrefractorymetastatic+BSC（最佳支持

mCRC≥3L治療）和黃醫(yī)藥

呋喹替尼colorectalcancerFruquintinibplussintilimabinrefractoryrepair-proficient(pMMR)/microsatelliteph2

stable(MSS)metastaticcolorectalcancer(mCRC):Preliminaryclinicalresultsand

423PbiomarkeranalysesfromaphaseIIstudy呋喹替尼

+信迪利單抗mCRC≥3LThesafetyandefficacyofsurufatinibforthetreatmentofadvancedneuroendocrinetumors:Aprospective,multicenter,real-worldstudy索凡替尼

+最佳支持治療

神經(jīng)內(nèi)分泌瘤NANA898PSurufatinibcombinedwithsintilimabandIBI310inthetreatmentofhigh-gradeadvanced-neuroendocrineneoplasm:Asinglearm,open-label,multicenterstudy索凡替尼

+信迪利單抗+伊

神經(jīng)內(nèi)分泌瘤匹木單抗499TiP627MOOrelabrutinibplusRCHOPforpreviouslyuntreatednon-germinalcenterbcell-like(GCB)diffuselargebcelllymphoma(DLBCL)patientswithextranodaldisease諾誠健華

奧布替尼

+RCHOPDLBCL非

GCB1L

NA資料

：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理其他國產(chǎn)創(chuàng)新藥

ESMO展示壁報(bào)（2）表：其他國產(chǎn)創(chuàng)新藥

ESMO展示壁報(bào)（2）公司分子方案適應(yīng)癥臨床

標(biāo)題AphaseIIsingle-armclinicalstudyofneoadjuvanttreatmentwithpegylatedph2

liposomaldoxorubicin(PLD)pluscyclophosphamide(C)combinedwith編號石藥集團(tuán)

聚乙二醇化+曲妥珠+帕妥

eBCHER2+新輔助192P多柔比星脂質(zhì)體

珠+環(huán)磷酰胺trastuzumab(H)andpertuzumab(P)inHER2-positive(HER2+)breastcancer(BC)結(jié)外

NK/T細(xì)胞淋巴瘤1LCombinationofmitoxantronehydrochlorideliposomewithpegaspargaseinph1/2

patientswithextranodalNK/T-celllymphoma:AphaseI/IIclinicaltrial米托蒽醌脂質(zhì)體

+培門冬酶625MO981PAphaseIIastudytoevaluatesafetyandefficacyofrezivertinib(BPI-7711)BPI-7711SYHA1813單藥單藥NSCLCEGFRm1Lph2a

inlocallyadvancedormetastatic/recurrenttreatment-na?veNSCLCpatientswithEGFRmutationAmulticenter,open-label,dose-escalation(DE),first-in-humanstudyofph1

VEGFRsandCSF1RinhibitorSYHA1813inpatients(pts)withrecurrenthigh-gradegliomas(HGG)oradvancedsolidtumors實(shí)體瘤302PDonafenibinlocallyadvanced/metastatic,radioactiveiodine-refractory,ph3

differentiatedthyroidcancer:A

randomized,double-blind,placebo-controlled,

1644Omulti-centerphaseIIIclinicaltrial(DIRECTION)澤璟制藥

多納非尼迪哲醫(yī)藥

舒沃替尼DZD1516單藥單藥單藥分化型甲狀腺癌NSCLCEGFRex20ins2LSunvozertinibforNSCLCpatientswithEGFRexon20insertionmutations:PreliminaryanalysisofWU-KONG6,thefirstpivotalstudyph2987PClinicalsafetyandpharmacokinetics(PK)dataofDZD1516,anBBB-penetrantph1

selectiveHER2inhibitorforthetreatmentofHER2-positivemetastaticbreast

238PcancermBCHER2+≥2LGCCLDN18.2+1L實(shí)體瘤

末線UpdatedreportofaphaseIstudyofTST001,ahumanizedanti-CLDN18.2ph1

monoclonalantibody,incombinationwithcapecitabineandoxaliplatin(CAPOX)

1254Pasafirst-linetreatmentofadvancedG/GEJcancer創(chuàng)勝集團(tuán)

TST001+化療PhaseIresultsdemonstratehighlydifferentiatedsafetyandPKprofileofph1

ADG126,amaskedanti-CTLA-4SAFEbodyinpatientswithadvancedsolidtumors

741P天演藥業(yè)

ADG126單藥資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理目錄010203中國企業(yè)

ESMO壁報(bào)一覽重點(diǎn)品種臨床數(shù)據(jù)分析其他相關(guān)研究數(shù)據(jù)更新11恒瑞醫(yī)藥：卡瑞利珠單抗展示肝癌一線及多項(xiàng)輔助/新輔助數(shù)據(jù)?

卡瑞利珠單抗聯(lián)合阿帕替尼（“雙艾”組合）一線治療晚期肝細(xì)胞癌的全球多中心

ph3臨床試驗(yàn)雙終點(diǎn)

OS和

PFS數(shù)據(jù)讀出，頭對頭索拉非尼均達(dá)到顯著性的獲益。另外，卡瑞利珠單抗聯(lián)合小分子

TKI或化療在多項(xiàng)實(shí)體瘤的輔助、新輔助治療也有早期臨床數(shù)據(jù)讀出。表：恒瑞醫(yī)藥

ESMO展示數(shù)據(jù)（卡瑞利珠單抗）分子方案適應(yīng)癥臨床

編號

試驗(yàn)設(shè)計(jì)患者人數(shù)mOSmPFSORRDCR卡瑞利珠單抗

+阿帕替尼HCC1Lph3

LBA35

對照（vs索拉非尼）對照（圍術(shù)期

vs手術(shù)后272vs

271

22.1vs15.2*

5.6vs3.7*

25.4%vs5.9%*+阿帕替尼HCC圍手術(shù)期NA712P）13vs

1141vs

4162.5%100%22.7vs16.4m（mRFS）+阿帕替尼+阿帕替尼HCC輔助ph2

724P

對照（vsHAI）NPC2Lph2

663P

單臂ph2

1250P

單臂ph2

726P

單臂ph2

562P

單臂ph2

170P

單臂582026252010.411.065.5%75.0%57.7%96.0%95%86.2%100%+阿帕替尼+化療

GC1L+侖伐替尼+HAIC

HCC14.0+cCRTCC局部晚期

鞏固治療100%+化療TNBC新輔助MPR=38.5%cPR=19.2%+化療sqLC圍手術(shù)期ph2

942P

單臂26+化療+化療CC局部晚期

新輔助UC≥2Lph2

560P

單臂ph2

1744P

單臂4820100%25%5.8192.1%

97.3%（12mOS%）

（12mDFS%）+化療ESCC局部晚期

新輔助ph2

1256P

單臂4783%+化療+化療+化療ESCC局部晚期

新輔助ESCC局部晚期

新輔助NANA1234P

單臂3046.7%74.1%1225P

單臂28GC/GEJ局部晚期

新輔助

NA1220P

對照（vs化療）23vs

31資料

：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理。注：如無特殊注明，PS、PFS時(shí)間單位為月；*表示顯著性差異；HAI=hepaticarterialinfusion（肝動(dòng)脈灌注）；RFS=無復(fù)發(fā)生存期恒瑞醫(yī)藥：吡咯替尼、達(dá)爾西利一線數(shù)據(jù)讀出?

達(dá)爾西利聯(lián)合芳香化酶抑制劑一線治療

HR+/HER2-晚期乳腺癌的

ph3臨床（DAWNA-2）中期分析讀出陽性

PFS數(shù)據(jù)（30.6vs18.2月），成為全球第四個(gè)（國產(chǎn)第一）讀出一線

PFS陽性數(shù)據(jù)的

CDK4/6抑制劑；同時(shí)，達(dá)爾西利聯(lián)合氟維司群二線治療

HR+/HER2-晚期乳腺癌的

ph3臨床（DAWNA-1）更新了數(shù)據(jù)分析，達(dá)爾西利對比安慰劑的

PFS獲益顯著，且在絕經(jīng)前、絕經(jīng)后女性中均有獲益。吡咯替尼聯(lián)合曲妥珠單抗和多西他賽一線治療

HER2+晚期乳腺癌的

ph3臨床（PHILA）同樣讀出陽性

PFS數(shù)據(jù)（24.3vs10.4月）。表：恒瑞醫(yī)藥

ESMO展示數(shù)據(jù)（其他）分子方案適應(yīng)癥臨床

編號

試驗(yàn)設(shè)計(jì)患者人數(shù)mOSmPFSORRDCR182vs63d*167vs63d*（TNBC）阿帕替尼+化療mBCHER2-2/3Lph2

247P

對照（vs化療）40vs40+特瑞普利單抗

GC2L+化療

GC1L+曲妥珠+化療

mBCHER2+1Lph2

1247P

對照（vs化療）ph1

1257P

劑量爬坡26

vs26163.0vs3.210.615%(實(shí)驗(yàn)組)18.667吡咯替尼達(dá)爾西利ph3

LBA19

對照297vs2937924.3

vs10.4*15.03（vs曲妥珠+化療）+化療mBCHER2+1Lph2

239P

單臂77.2%+來曲唑/阿那曲唑?qū)φ眨╲s來曲唑LBA16

/阿那曲唑）對照（vs氟維司群mBCHR+/HER2-1L

ph3303vs15330.6

vs18.2*

57.4%vs47.7%16.6

vs7.2*+氟維司群mBCHR+/HER2-2L

ph3241vs11015229P）頭頸部黏膜黑色素瘤單藥ph2

880P

單臂NR5.56.7%80%CDK4+≥2L阿得貝利單抗

單藥實(shí)體瘤ph1

744P

劑量爬坡4124.4%58.5%HR070803+5-FU/LVmPC2Lph3

LBA61

對照（vs5-FU/LV）2987.39vs4.99*4.21vs1.48*

12.75%vs0.67%*：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理。注：如無特殊注明，PS、PFS時(shí)間單位為月；*表示顯著性差異；5-FU/LV即

5-氟尿嘧啶和甲酰四氫葉酸方案。資料卡瑞利珠+阿帕替尼對照索拉非尼在一線肝癌讀出陽性數(shù)據(jù)（LBA35）?

試驗(yàn)設(shè)計(jì)：這是一項(xiàng)針對一線治療不可切除的肝細(xì)胞癌（HCC1L）患者的國際多中心、隨機(jī)對照，開放標(biāo)簽的

3期臨床試驗(yàn)；患者被

1：1隨機(jī)分組到實(shí)驗(yàn)組（卡瑞利珠單抗+阿帕替尼）和對照組（索拉非尼）。試驗(yàn)的主要臨床終點(diǎn)為

PFS和

OS（RECISTv1.1）；首次PFS分析在

339個(gè)

PFS事件發(fā)生后進(jìn)行（2021/5/10），計(jì)劃中的中期

OS分析在

262個(gè)

事件發(fā)生后進(jìn)行（2022/2/8）。?

有效性數(shù)據(jù)：卡瑞利珠單抗+阿帕替尼組在雙終點(diǎn)

mOS和

mPFS上均顯著優(yōu)于索拉非尼組。在中位隨訪時(shí)間

7.8個(gè)月后，實(shí)驗(yàn)組

vs對照組的

mPFS為

5.6[95%CI5.5-6.3]vs.3.7[2.8-3.7]月；HR0.52[95%CI0.41-0.65]；在中位隨訪時(shí)間

14.5個(gè)月后，實(shí)驗(yàn)組

vs對照組的

mOS為

22.1[95%CI19.1-27.2]vs.15.2[13.0-18.5]月;HR0.62[95%CI0.49-0.80]。實(shí)驗(yàn)組在

ORR、DCR、DoR等均有優(yōu)勢，并且在大部分預(yù)先設(shè)置的亞組中的

PFS和

OS的

HR在均明顯占優(yōu)。?

安全性數(shù)據(jù)：實(shí)驗(yàn)組

vs對照組的三級以上

TRAE發(fā)生率為

80.9%vs52.4%，造成治療終止的

STRAE發(fā)生率為

24.3%vs4.5%，每組均有一例因?yàn)椴涣挤磻?yīng)造成的

。表：卡瑞利珠單抗+阿帕替尼

HCC1L適應(yīng)癥的臨床數(shù)據(jù)（LBA35/NCT03764293）卡瑞利珠單抗+阿帕替尼（N=272）索拉非尼（N=271）單邊

P值mOS(95%CI)，月HR(95%

CI)22.1(19.1-27.2)15.2(13.0-18.5)0.62

(0.49-0.80)<0.0001mPFS(95%CI)，月HR(95%

CI)5.6(5.5-6.3)3.7

(2.8-3.7)0.52

(0.41-0.65)<0.0001ORR(95%CI),%mDoR(95%

CI)，月DCR(95%CI),%mTTP(95%

CI)，月25.4(20.3-31.0)14.8(8.4-NR)5.9

(3.4-9.4)9.2(5.3-NR)<0.0001---78.3(72.9-83.1)7.2(5.6-8.2)53.9(47.7-59.9)3.7

(3.6-3.7)資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理相關(guān)研究：“可樂”組合

HCC1L雙終點(diǎn)未達(dá)顯著性（LEAP-002）?

LEAP-002是

Pembrolizumab（K藥）聯(lián)合侖伐替尼（“可樂”組合）頭對頭安慰劑聯(lián)合侖伐替尼治療

HCC1L的全球多中心、隨機(jī)雙盲ph3臨床，采用

OS、PFS的雙終點(diǎn)設(shè)計(jì)，共

794名患者

1：1隨機(jī)分配至實(shí)驗(yàn)組和對照組。在最終分析時(shí)（LBA34），實(shí)驗(yàn)組和對照組的mOS分別為

21.2vs19.0月，HR為

0.840(95%CI:0.708-0.997,P=0.0227）。第一次中期分析時(shí)，mPFS分別為

8.2vs8.0月，HR為

0.867(95%CI:0.734-1.024,P=0.0466）。盡管

K藥+侖伐替尼在一線肝癌展示了良好的有效性數(shù)據(jù)，對比對照組（侖伐替尼）展示出臨床獲益的趨勢；但是基于

LEAP-002的臨床設(shè)計(jì)以及統(tǒng)計(jì)學(xué)假設(shè)，OS和

PFS雙終點(diǎn)均未達(dá)到。圖：LEAP-002OS曲線圖：LEAP-002PFS曲線資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理資料：ESMO官網(wǎng)、國信證券經(jīng)濟(jì)研究所整理一線肝癌數(shù)據(jù)對比：“A+T”成金標(biāo)準(zhǔn)，“雙艾”撞線，“可樂”折戟表：一線肝癌治療數(shù)據(jù)對比公司羅氏IMbrave150恒瑞醫(yī)藥SHR-1210-III-3102019.06默沙東LEAP-002阿斯利康HIMALAYA信達(dá)生物Orient-32*臨床試驗(yàn)開始時(shí)間獲批時(shí)間組合2018.032018.122017.102019.022020.05（FDA）/2020.09（中國）阿替利珠單抗+貝伐珠單抗索拉非尼2021.12（中國申報(bào)）卡瑞利珠單抗+阿帕替尼索拉非尼臨床失敗2022.04（FDA

申報(bào)）度伐利尤單抗+替西木單抗索拉非尼2021.06（中國批準(zhǔn)）信迪利單抗+貝伐珠單抗索拉非尼帕博利珠單抗+侖伐替尼侖伐替尼對照入組人數(shù)336vs165272vs271395vs399388vs374380vs18522.121.219.213.419.015.216.413.8mOS（月）+5.8m+6.9m+2.2m+2.7mNA10.4HR=0.66HR=0.62HR=0.84HR=0.78HR=0.57NR8.28.06.95.64.34.14.6+1.8mmPFS（月）+2.6m+1.9m+0.2m3.73.8-0.3m2.8HR=0.65HR=0.52HR=0.87HR=0.90HR=0.5630%25.4%80.9%26.1%20.1%21%17.5%ORR11%5.9%5.1%4%62.5%57.5%52.4%43%

46%36.9%≥3

TRAE25.8%資料：ESMO

官網(wǎng)、Insight、國信證券經(jīng)濟(jì)研究所整理。*Orient-32

為中國地區(qū)臨床，其他均為全球多中心臨床。吡咯替尼一線治療晚期

HER2+乳腺癌達(dá)到主要臨床終點(diǎn)（PHILA）?

試驗(yàn)設(shè)計(jì)：PHILA是一項(xiàng)針對一線治療

HER2陽性復(fù)發(fā)/轉(zhuǎn)移性乳腺癌（mBCHER2+1L）患者的中國地區(qū)的隨機(jī)對照，雙盲的

3期臨床試驗(yàn)；患者被

1：1隨機(jī)分組到實(shí)驗(yàn)組（吡咯替尼+曲妥珠單抗+多西他賽）和對照組（安慰劑+曲妥珠單抗+多西他賽）。試驗(yàn)的主要臨床終點(diǎn)為

PFS。?

有效性數(shù)據(jù)：590名患者被隨機(jī)分組（實(shí)驗(yàn)組：對照組=297：293），兩組的中位隨訪時(shí)間分別為

15.8和

14.9個(gè)月。實(shí)驗(yàn)組和對照組的

mPFS分別為

24.3月

[95%CI19.1-33.0]vs10.4月

[95%CI9.3-12.3];HR,0.41[95%CI0.32-0.53];P<0.0001，實(shí)驗(yàn)組顯著優(yōu)于對照組；并且在各亞組（ECOG評分

0/1；是否接受過輔助或新輔助治療；是否接受過含曲妥珠的輔助或新輔助治療；輔助治療后的時(shí)間間隔是否大于兩年）分析中，實(shí)驗(yàn)組均顯著優(yōu)于對照組。?

安全性數(shù)據(jù)：最常見的≥3

級

TRAE是中性粒細(xì)胞數(shù)量減少（62.6%vs65.2%），白細(xì)胞數(shù)量減少（53.2%vs50.9%）和腹瀉（46.5%vs3.1%）。3級

TRAE主要在第一個(gè)治療周期發(fā)生，并在第二個(gè)治療周期及之后大幅減少。沒有

4/5級

TRAE發(fā)生。嚴(yán)重的

TRAE發(fā)生比例為24.9%vs6.1%，治療相關(guān)的分別為

0vs0.3%。?

吡咯替尼是

HER2小分子抑制劑，2018年獲批上市，聯(lián)合卡培他濱用于晚期乳腺癌的二線治療，并在

2019年納入醫(yī)保。2022年

5月，吡咯替尼聯(lián)合曲妥珠單抗和多西他賽用于早期或局部晚期

HER2陽性乳腺癌的新輔助治療。目前吡咯替尼正在開展的

3期注冊性臨床包括：1）晚期

HER2+乳腺癌的一線治療（吡咯替尼+曲妥珠單抗+多西他賽

vs安慰劑+曲妥珠單抗+多西他賽）2）早期/局部晚期

HER2+乳腺癌的延長輔助治療（曲妥珠單抗輔助治療后

吡咯替尼

vs安慰劑）3）晚期

HER2ex20mutNSCLC的二線治療（吡咯替尼

vs多西他賽）圖：吡咯替尼臨床進(jìn)度資料：恒瑞醫(yī)藥公司公告、國信證券經(jīng)濟(jì)研究所整理達(dá)爾西利二線治療晚期

HR+/HER2-乳腺癌更新數(shù)據(jù)（DAWNA-1）?

試驗(yàn)設(shè)計(jì)：DAWNA-1是一項(xiàng)針對內(nèi)分泌治療后復(fù)發(fā)的

HR+/HER2-局部晚期/轉(zhuǎn)移性乳腺癌（mBC

HR+/HER2-

2L）患者的中國地區(qū)的隨機(jī)對照，雙盲的

3期臨床試驗(yàn)；患者被

2：1隨機(jī)分組到實(shí)驗(yàn)組（達(dá)爾西利+氟維司群）和對照組（安慰劑+氟維司群）。此前的數(shù)據(jù)已經(jīng)展示了達(dá)爾西利可以顯著提升

mBCHR+/HER2-2L患者的

PFS，此次更新了另外的一年以上隨訪的分析數(shù)據(jù)。?

有效性數(shù)據(jù)：361名患者被隨機(jī)分組（實(shí)驗(yàn)組：對照組=241：120），兩組的中位隨訪時(shí)間分別為

25.2和

24.5個(gè)月。實(shí)驗(yàn)組和對照組的

mPFS分別為

16.6月

[95%CI15.2-18.6]vs7.2月

[95%CI5.6-9.2];HR,0.50[95%CI0.39-0.65];1-sidedp<0.0001，實(shí)驗(yàn)組顯著優(yōu)于對照組。達(dá)爾西利在

PFS上的優(yōu)勢在絕經(jīng)前（HR0.55[95%CI0.37-0.82]）和絕經(jīng)后（HR0.44[95%CI0.31-0.62]）的患者中同樣顯著。兩組的

ORR分別為

35.7%和

23.3%，mDoR分別為

20.8月(95%CI17.2-NR)和

10.2月(95%CI7.3-21.7)。達(dá)爾西利組在后續(xù)化療的間隔時(shí)間上也有優(yōu)勢（24.0vs11.8月）。?

安全性數(shù)據(jù)：SAE發(fā)生的比例為

8.8%vs9.2%，因不良反應(yīng)而終止治療的比例分別為

2.9%vs4.2%。?

達(dá)爾西利是

CDK4/6抑制劑，2021年

12月獲批上市，用于治療

HR+/HER2-的經(jīng)內(nèi)分泌治療后進(jìn)展的復(fù)發(fā)或轉(zhuǎn)移性乳腺癌患者。目前達(dá)爾西利正在開展的

3期注冊性臨床包括：1）晚期

HR+/HER2-乳腺癌的一線治療（達(dá)爾西利+來曲唑/阿那曲唑

vs安慰劑+來曲唑/阿那曲唑）2）早期

HR+/HER2-乳腺癌的輔助治療（達(dá)爾西利+內(nèi)分泌治療

vs安慰劑+內(nèi)分泌治療）圖：達(dá)爾西利臨床進(jìn)度資料：恒瑞醫(yī)藥公司公告、國信證券經(jīng)濟(jì)研究所整理達(dá)爾西利一線治療晚期

HR+/HER2-乳腺癌讀出陽性數(shù)據(jù)（DAWNA-2）?

試驗(yàn)設(shè)計(jì)：DAWNA-2是一項(xiàng)針對一線治療

HR+/HER2-復(fù)發(fā)/轉(zhuǎn)移性乳腺癌（mBCHR+/HER2-1L）患者的中國地區(qū)的隨機(jī)對照，雙盲的

3期臨床試驗(yàn)；患者被

2：1隨機(jī)分組到實(shí)驗(yàn)組（達(dá)爾西利+來曲唑/阿那曲唑）和對照組（安慰劑+來曲唑/阿那曲唑）。試驗(yàn)的主要臨床終點(diǎn)為

PFS。在

186各

PFS事件發(fā)生后（2022/6/1），進(jìn)行了預(yù)先指定的中期分析，相對應(yīng)的優(yōu)效界限是單邊

P<0.0076。?

有效性數(shù)據(jù)：456名患者被隨機(jī)分組（實(shí)驗(yàn)組：對照組=303：153），兩組的中位隨訪時(shí)間分別為

21.7和

21.4個(gè)月。實(shí)驗(yàn)組和對照組的

mPFS分別為

30.6個(gè)月[95%CI30.6-NR]和

18.2月[95%CI16.5-22.5];HR,0.51[95%CI0.38-0.69];單邊

P<0.0001，實(shí)驗(yàn)組顯著優(yōu)于對照組。達(dá)爾西利在

PFS上的優(yōu)勢在絕經(jīng)前和絕經(jīng)后的患者中同樣顯著，在

ORR、DoR等指標(biāo)中同樣占優(yōu)。?

安全性數(shù)據(jù)：實(shí)驗(yàn)組中最常見的≥3

級

TRAE是中性粒細(xì)胞數(shù)量減少（85.8%[grade3/4,64.6%/21.2%]vs0）和白細(xì)胞數(shù)量減少（66.6%[grade3/4,65.9%/0.7%]vs0）。SAE發(fā)生的比例為

11.9%vs6.5%，因不良反應(yīng)而終止治療的比例分別為

4.0%vs2.0%。表：達(dá)爾西利+來曲唑/阿那曲唑

mBCHR+/HER2-1L適應(yīng)癥的臨床數(shù)據(jù)（LBA16/DAWNA-2）達(dá)爾西利+來曲唑/阿那曲唑（N