里程碑！欧盟批准罗氏安维汀（Avastin）联合化疗治疗晚期宫颈癌

2015年4月7日讯/生物谷BIOON/--安维汀（Avastin）是瑞士制药巨头罗氏（Roche）第二畅销的抗癌药物，2014年全球销售额高达70.21亿美元，位列《2014年全球最畅销的25个药物》榜单第7名。在欧盟，Avastin已获批的适应症包括：乳腺癌、结直肠癌、非小细胞肺癌、卵巢癌。
近日，Avastin（bevacizumab，贝伐单抗）在欧盟监管方面再度传来喜讯，欧盟委员会（EC）已批准Avastin联合标准化疗（紫杉醇+顺铂，或紫杉醇+拓扑替康）用于持续性、复发性或转移性宫颈癌的治疗。Avastin是继2006年拓扑替康和顺铂获批近10年来，批准用于治疗晚期宫颈癌的首个新药，标志着宫颈癌临床治疗的重大里程碑。目前，在欧盟地区，晚期宫颈癌的治疗选择仅限于化疗。在当前标准化疗方案基础上联用Avastin，将为晚期宫颈癌患者提供更显著的治疗益处。
Avastin宫颈癌新适应症的获批，是基于关键性大型III期GOG-0240研究的显著生存数据。GOG-0240是一项独立的、由美国国家癌症研究所（NCI）资助的妇科肿瘤组（GOG）III期临床研究，在452例持续性复发性或转移性宫颈癌患者中开展，旨在评估Avastin联合标准化疗（紫杉醇+顺铂，或紫杉醇+拓扑替康）的疗效及安全性，研究的主要终点为总生存期（OS）。数据显示，与化疗（紫杉醇+顺铂，或紫杉醇+拓扑替康）相比，Avastin联合化疗（紫杉醇+顺铂，或紫杉醇+拓扑替康）使死亡风险显著降低26%，总生存期（OS）提高近4个月（中位OS：16.8个月vs12.9个月，HR=0.74，p=0.0132）。此外，Avastin联合化疗组也表现出显著更高比例的肿瘤缩小（ORR，客观缓解率：45%vs34%）。安全性方面，Avastin联合化疗组除了胃肠-阴道瘘发生率升高（8.9%vs0.9%）之外，安全属性与以往横跨各种肿瘤类型的关键研究表现一致。
同样根据GOG-0240研究的数据，Avastin联合化疗（紫杉醇+顺铂，或紫杉醇+拓扑替康）已分别获美国、瑞士及其他6个国家批准，用于持续性复发性或转移性宫颈癌的治疗。
关于宫颈癌：
宫颈癌是发生于子宫下部组织子宫颈的癌症，是最常见的妇科恶性肿瘤，近年来其发病有年轻化的趋势。人乳头瘤病毒（HPV）持续感染是宫颈癌的主要危险因素，90%以上的宫颈癌伴有高危型HPV感染。
与其他大多数癌症不同，宫颈癌是较年轻女性（35-44岁）中最常确诊的癌症类型。据估计，在欧盟每年约有3.3万例新诊病例，并有1.3万例患者死亡。在全球范围内，每年有超过50万宫颈癌新诊病例，死亡病例超过26万，使之成为全球女性癌症死亡的第四大病因。
英文原文：EUapprovesRochesAvastinpluschemotherapyforwomenwithadvancedcervicalcancer
Avastinisthefirsttreatmentinnearlyadecadetoextendthelifeofwomenwiththisadvanceddisease
Roche(SIX:RO,ROG,OTCQX,RHHBY)announcedtodaythattheEuropeanCommission(EU)approvedAvastin(bevacizumab)incombinationwithstandardchemotherapy(paclitaxelandcisplatinor,alternatively,paclitaxelandtopotecaninpatientswhocannotreceiveplatinumtherapy)forthetreatmentofadultpatientswithpersistent,recurrentormetastaticcarcinomaofthecervix.1
Unlikethemajorityofcancers,cervicalcancerismostcommonlydiagnosedinyoungerwomen,betweentheagesof35and44.2Eachdayitisestimatedthat90womenarediagnosedwithcervicalcancerinEurope,andaround35ofthesewomenwilldiefromthedisease.3Avastin’sEUapprovalinpersistent,recurrentormetastaticcarcinomaofthecervixisanimportantdevelopmentinadiseaseareawhere,untilnow,treatmentoptionswerelimitedtochemotherapy.
“WearepleasedthatwomeninEuropenowhaveamuchneedednewtreatmentoptionthatisproventohelpthemlivelongerlivescomparedtochemotherapyalone,”saidSandraHorning,M.D.,ChiefMedicalOfficerandHeadofGlobalProductDevelopment.“Currently,fewerthanoneinsixwomenwiththisdiseasearealivefiveyearsafterdiagnosis.Avastin’sapprovalisawelcomeadvanceforwomenwithpersistent,recurrentormetastaticcarcinomaofthecervix”.
TheEUapprovalwasbasedonthesignificantsurvivalbenefitinthepivotalGOG-0240study,whichshowedthatwomenwhoreceivedAvastinpluschemotherapyhadastatisticallysignificant26percentreductionintheriskofdeath,representingamedianimprovementinsurvivalofnearlyfourmonths,comparedtowomenwhoreceivedchemotherapyalone(medianoverallsurvival:16.8monthsvs.12.9months;HazardRatio(HR)=0.74,p=0.0132).1
AlsobasedontheGOG-0240data,AvastinincombinationwithpaclitaxelandcisplatinorpaclitaxelandtopotecanchemotherapywasapprovedintheU.S.inAugust2014,inSwitzerlandinDecember2014,andinsixothercountriesworldwide,forthetreatmentofwomenwithpersistent,recurrentormetastaticcarcinomaofthecervix.
AbouttheGOG-0240study1
GOG-0240isanindependent,NationalCancerInstitute(NCI)-sponsoredstudyoftheGynecologicalOncologyGroup(GOG)thatassessedtheefficacyandsafetyprofileofAvastinpluschemotherapy(paclitaxelandcisplatinorpaclitaxelandtopotecan)inwomenwithpersistent,recurrentormetastaticcarcinomaofthecervix.
Studydatafrom452womenshowed:
Thestudymetitsprimaryendpointofimprovingoverallsurvival(OS)withastatisticallysignificant26percentreductionintheriskofdeath,representingamediangaininsurvivalof3.9months,comparedwiththosewhoreceivedchemotherapyalone(medianoverallsurvival:16.8monthsvs.12.9months;(HR)=0.74,p=0.0132).1
ThestudyshowedthatwomenwhoreceivedAvastinpluschemotherapyhadasignificantlyhigherrateoftumourshrinkage(objectiveresponserate,ORR)comparedwiththosewhoreceivedchemotherapyalone(45percent[95%CI:0.39%-0.52%]vs.34percent[95%CI0.28%-0.40%]).1
Overall,thesafetyprofileinthestudywasconsistentwiththatseeninpreviouspivotalstudiesofAvastinacrosstumourtypes,exceptforanincreaseingastrointestinal-vaginalfistulaeobservedinpatientswhoreceivedAvastinpluschemotherapycomparedtothosewhoreceivedchemotherapyalone(8.3%vs.0.9%respectively).Allpatientswithgastrointestinal-vaginalfistulaeaftertreatmentwithAvastinpluschemotherapyhadahistoryofpriorpelvicradiation.1
Aboutcervicalcancer
Itisestimatedthatover33,000womenwillbediagnosedwithcervicalcancerintheEUthisyearandabout13,000womenwilldiefromthedisease.3Whilethechancesofsurvivalarehigherifthediseaseiscaughtearly(atleastnineoutof10womensurviveforfiveyearsorlongerfollowingearlydiagnosis),thesymptomsofearly-stagecervicalcancercanbeeasilymissed,andmanywomenarenotdiagnoseduntiltheircancerhasalreadyprogressedtoanadvancedstage.2,4Atthisstage,thesurvivalratesarereducedandfewerthanoneinsixwomensurviveforfiveyearsorlonger.2,4
Worldwide,itisestimatedtherearemorethanhalfamillioncasesofcervicalcancereveryyearandover260,000deathsfromthedisease,makingitthefourthleadingcauseofcancerdeathinwomenglobally.5
AboutAvastin
WiththeinitialapprovalintheUnitedStatesforadvancedcolorectalcancerin2004,Avastinbecamethefirstanti-angiogenictherapymadewidelyavailableforthetreatmentofpatientswithanadvancedcancer.
Today,Avastiniscontinuingtotransformcancercarethroughitsprovensurvivalbenefit(overallsurvivaland/orprogressionfreesurvival)acrossseveraltypesofcancer.AvastinisapprovedinEuropeforthetreatmentofadvancedstagesofbreastcancer,colorectalcancer,non-smallcelllungcancer,kidneycancer,ovariancancer,andnowcervicalcancer,andisavailableintheUnitedStatesforthetreatmentofcolorectalcancer,non-smallcelllungcancer,kidneycancer,cervicalcancerandplatinum-resistant,recurrentovariancancer.Inaddition,AvastinisapprovedintheUnitedStatesandover60othercountriesworldwideforthetreatmentofpatientswithprogressiveglioblastomafollowingpriortherapy.AvastinisapprovedinJapanforthetreatmentoftheadvancedstagesofcolorectal,non-smallcelllungcancer,breastcancer,ovariancancerandmalignantglioma,includingnewlydiagnosedglioblastoma.
Avastinhasmadeanti-angiogenictherapyafundamentalpillarofcancertreatmenttoday.Over1.5millionpatientshavebeentreatedwithAvastinsofar.Acomprehensiveclinicalprogrammewithmorethan500ongoingclinicaltrialsisinvestigatingtheuseofAvastininover50tumourtypes.
AboutAvastin–mechanismofaction
Anindependentbloodsupplyiscriticalforatumourtogrowbeyondacertainsize(2mm)andspread(metastasise)tootherpartsofthebody.Tumoursdeveloptheirownbloodsupplyinaprocesscalledangiogenesisbyreleasingvascularendothelialgrowthfactor(VEGF)–akeydriverfortumourgrowth.AvastinisanantibodythatpreciselytargetsandinhibitsVEGF.PreciseVEGFinhibitionbyAvastinallowsittobecombinedeffectivelywithabroadrangeofchemotherapiesandotheranti-cancertreatmentswithlimitedadditionalimpactonthesideeffectsofthesetherapies.
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