【医疗研报】中国医药、医疗行业：2022年ASH血液学会议数据读出总结-20221209-招商证券（.docx

CMS®ftff111BA磅研究数据读出1BA篁磅研究展示前沿进展ASH2023一共收录了6项1BA重磅研究，这些研究进展可能在血液肿瘤领域带来具有变革性的治疗获益，其中我们注意至IJAmgen/Beigene的B1inatUmOmab（CD3xCD19BsAb）显示显著OS获益，展示了在治疗A11方向上成为新标准疗法的潜力（1BA-1）；同时，BeigeneNZanubrutinib（BTKi）相比较第一代BTKi在ORR和PFS读出方面展示出优越性（1BA-6）。I图1ASH2023重磅研究数据读出No.公句（商岛名）况点分Ma适应症。廉阶段伊人级人敷）实舍称(NCTID)治疗方案ORR(%)CR(%)mPFS(mos)m0S(mos)(mos)1BA-1Amgen/Aste11a/BeiGeneB1inatumomab(BIincyto)CD3×CD19BsAb11A11Ph3(n=722)Ecog-AcrinE1910(NCT02003222)81%treachedv.s71mos43Conso1idationTherapywithB1inatumomabImprovesOvera11Surviva1inNew1yDiagnosedAdu1tPatientswithB-1ineageAte1ymphob1astic1eukemiainMeasurab1eResidua1DiseaseNegativeRemission:Resu1tsfromtheECOG-ACRINE1910RandomizedPhaseIIINationa1CooperativeC1inica1Tria1sNetworkTria11BA-2NovartisIptacopanFactorBSMDPNH1AnemiaPh3(n=97)AppIyPNHIPTv.sSoCOra1MonotherapywithIptacopan1aProxima1Comp1ementInhibitorofFactorB,HasSuperiorEffiCaeytoIntravenousTermina1Comp1ementInhibitionwrthStandardofCareEcu1izumaborRavu1izumabandFavorab1eSafetyinPatientswithParoxysma1Nocturna1Hemog1obinuriaandResidua1Anemia:Resu1tsfromtheRandomized,Active-Comparator-Contro11ed,Open-1abe1,Mu1ticenter,PhaseIIIAppIy-PNHStudy1BA-3UniversityofFreitxjrgeta1HDC-ASCTn.aCe11therapyCNS1ymphomaPh3(n=260)Conso1idatiMATRix/ontherapyIE1SG43(HOC-(NCT02531841)ASCTv.sR-DEVIC)52%3yrPFS:79%v.s53%3yrOS:86%v.s71%EffectsonSurviva1ofNon-Mye1oab1ativeChemoimmunotherapyComparedtoHigh-DoseChemotherapyFo11owedByAuto1ogous44StemCe11Transp1antation(HDC-ASCT)AsConso1idationTherapyinPatientswithPrimaryCNS1ymphoma-Resu1tsofanInternationa1RandomizedPhaseIIITria1(MATRixIE1SG43)1BA-4UniveristyofMinnesotaeta1a1foHCTn.aCe11therapyGVHDdiseasere1apsePh3(n=128)BMTCTN1703PTCyv.sTacMT×NosignificantdifferencePost-Transp1antCyc1ophosphamide,Tacro1imus,andMycopheno1ateMofeti1AstheNewStandardforGraf1-Versus-HostDisease(GVHD)Prophy1axisinReducedIntensityConditioning:Resu1tsfromPhaseIIIBMTCTN17031BA-5UniversityofWarwicketa1Heparinn.aSMDR/RA1IFE2Ph3(n=428)1MWHv.sSoC1ivebirthrate:71.6%v.s70.9%1ow-Mo1ecu1ar-WeightHeparinVersusStandardPregnancyCareforWomenwithRecurrentMiscarriageandInheritedThrombophi1ia(A1IFE2):AnOpen-1abe1.PhaseIIIRandomizedContro11edTria1()1BA-6BeiGeneZanukxutinib(Brukinsa)BTKSMDR/RC1US11Ph3(n=652)A1PINE(NCT03734016)Zanuv.sIbru86.2VS75.7%,P-0.07NRvs.35moP-0.002429.6Zanubcu1inibDemonstratesSuperiorProgression-FreeSurviva1(PFS)ComparedwithIbrutinibforTreatmentofReIapsedZRefractoryChronic1ymphocytic1eukemiaandSma111ymphocytic1ymphoma(R/RC1US11):Resu1tsfromFina1Ana1ysisofA1PINERandomizedPhase3Study资料来源:招商证券（香港），ASH2023多发性骨!病-研究进展多发性骨前沿研究进展：1)双抗领域取得进一步进展：继JOhnSOn的tec1istamab于2023年10月25日基于MajesTEC-I试验(n=165,NCT03145181NCT04557098,ORR=62%)首次获得FDA批准后，双抗在r/rMM治疗领域进一步取得进展。其中我们注意到以下资产读出优秀数据：Pfizer的e1ranatamab(BCMAXCD3BsAb)在Ph2Magnetismm-3试验中(NCT04649359,n=123)ORR读出61%,Regeneron的Iinvose1tamab在Ph12试验中(NCT03761108,n=167)ORR读出75%,以及Johnson的具有新靶点的双抗a1quetamab(GPRC5DXCD3BsAb)在Ph1/2MonumenTA1-I试验(NeTO3399799NCT04634552,n=288)中,ORR读出为73%o2)CAR-NK展示早期研究进展：除了BCMA靶向CAR-T细胞治疗以外，我们注意到FateTherapeutics的FT576采用可再生多全能干细胞技术为制备“现成产品”提供可能性<与此同时，在Ph1试验中所采用的两种剂量(IOom或30Om细胞/每剂量)，没有CRS,NT,或GVHD报道。尽管还在早期，NK细胞由于取材方便(例如，取自iPSC或NK细胞系)，和安全性更佳等优势成为下一个研发的方向。3)GPRC5D作为新型靶点：经过检测原代骨髓样本，GPRC5D(c1assCgroup5memberD)蛋白以独立于BCMA的方式在CD138+MM细胞中有表达3o我们注意到在该靶点上的早期临床试验读出具有潜力的数据，其中JOhnSOn的a1quetamab(GPRC5DXCD3BsAb)在Ph1/2MonumenTA1-I硼佥(NCTo3399799NCT04634552,n=288)中ORR读出73%,BMS的BMS-986393,GPRC5D靶向CAR-T疗法，在14个入组病人中读出高有效性(ORR读出86%)。除此之外，在经过前线BCMA靶向治疗的病人(其中4/5mAb,3/5CAR-T)种显示有效性。4)CD38单抗聚焦早期治疗：Johnso的daratumumab,根据NCCN治疗目前用于一线MM,在第三期IFM2017-03试验中(n=259,NCT03993912).ORR读出为89%。除此之外，Sanofi的Isatuximab在Ph3ITHACA试验中(n=23),用于治疗SMM(ORR读出为100%)。图2:ASH2023重磅研究数据读出-多发性骨髓瘤公司IB点分子奥81床阶段适SORR(%).CR(%)试3,独NCTIDMf1SGSK1Seagenbe1antamabmafodotiBCMAADCPh211MMORR:82.1%GEM-BE1A-VRd40NCT04802356Be1antamabMafodotininCombinationwithVrdfortheTreatmentofNew1yDiagnosedTransp1antE1igib1eMu1tip1eMye1omaPatients:Resu1tsfromthePhaseII,Open1abe1.Mu1ticenter,GEM-BE1A-VrdTria1CARsgenZevorcabtageneauto1euce1BCMACAR-TPh2r/rMMORR:92.8%CR/sCR:42.2%1UMMICst5Syi102NCT03975907PhaseI1StudyofFu11yHumanBCMA-TargetingCAR-TCe11s(ZevorcabtageneAuto1euce1)inPatientswithReIapsedZRefractoryMu1tip1eMye1omaBMS.Ce1geneIdecabtageneVic1euce1BCMACAR-TPh2MMORR:83.8%CR:45.9%KarMMa-239NCT03601078KarMMa-2Cohort2a:EfficacyandSafetyofIdecabtageneVic1euce1inC1inica1High-RiskMu1tip1eMye1omaPatientswithEar1yRe1apseafterFront1ineAuto1ogousStemCe11Transp1antationBMS.Ce1geneIdecabtageneVic1euce1BCMACAR-TPh2MMORR:87.1%KarMMa-232NCT03601078KarMMa-2Cohort2c:EfficacyandSafetyofIdecabtageneVic1euce1inPatientswithC1inica1High-RiskMu1tip