阿斯利康联手Myriad向胰腺癌个性化治疗发起冲锋

2015年4月3日讯/生物谷BIOON/--阿斯利康（AZN）与美国生物医药企业万基遗传(MyriadGenetics）近日联合宣布，双方将扩大在抗癌药Lynparza（olaparib）方面的合作，将Myriad开发的伴随诊断试剂盒（CDx）用于阿斯利康所关注的各类癌症。此次双方将利用Myriad开发的BRCAAnalysisCDx伴随诊断技术，识别可能对抗癌药Lynparza治疗有潜在反应的转移性胰腺癌患者。
Lynparza（olaparib）是阿斯利康研发的一种首创的口服多聚ADP核糖聚合酶（PARP）抑制剂，利用DNA修复途径的缺陷，优先杀死癌细胞。去年圣诞节前夕，Lynparza同时获得美国和欧盟批准，作为一种单药疗法用于铂敏感复发性BRCA胚系突变（gBRCAm）晚期卵巢癌成人患者的维持治疗，成为用于该患者群体的首个PARP抑制剂。
阿斯利康对Lynparza寄予厚望，认为该药的年销售额有望突破20亿美元。为了进一步推进史上首个PARP抑制剂的商业化成功，阿斯利康一直在努力扩大该药的标签，调查用于各种癌症的治疗，包括最致命的胰腺癌。目前，阿斯利康正开展多个III期研究，调查Lynparza用于BRCA突变胰腺癌、卵巢癌、乳腺癌、胃癌的治疗。
阿斯利康表示，与Myriad之间的合作是抗击胰腺癌所迈出的一大步，有望使胰腺癌的个性化治疗成为现实。Myriad开发的BRACAnalysisCDx检测技术有望快速并准确识别出可能从Lynparza治疗中受益的胰腺癌患者群体，并有望促进更好的健康预后。据估计，仅在美国，每年新增4.8万例胰腺癌病例，死亡4.0万例。
Myriad公司的BRACAnalysisCDx于去年12月首次获FDA批准，作为Lynparza的一种伴随诊断，用于卵巢癌患者的临床治疗。BRACAnalysisCDx是一种体外诊断设备，利用全血样本中提取的基因组DNA，识别各种形式的BRCA1和BRCA2基因。
关于BRCA基因：
BRCA1和BRCA2基因属于肿瘤抑制因子编码基因，这些基因的突变，与遗传性乳腺癌和卵巢癌相关。若一个女性继承了BRCA1或BRCA2突变，患乳腺癌和/或卵巢癌的风险将大大增加。在癌细胞扩增至卵巢以外之前，仅有15%的卵巢癌被发现。尽管当前治疗和诊断已经取得了很大进步，但癌细胞已扩散至卵巢外的患者，5年生存率低于50%。
关于Lynparza（olaparib）：
Olaparib是一种创新的、潜在首创口服多聚ADP核糖聚合酶（PARP）抑制剂，在临床前模型中已被证明，能够利用DNA修复途径的缺陷，优先杀死癌细胞。这种作用模式，赋予olaparib治疗具有DNA修复缺陷的广泛肿瘤类型的潜力。PARP与广泛的肿瘤类型相关，尤其是乳腺癌和卵巢癌。
英文原文：AstraZenecaplc(ADR)AndMyriadGenetics,Inc.ExpandCollaborationOnLynparzaMyriad’sBRACAnalysisCDxtestwillbeusedtoidentifyprospectivepatientsofmetastaticpancreaticcancerwhocouldrespondtoAstraZeneca’sLynparza
AstraZenecaplc(ADR)(NYSE:AZN)andMyriadGenetics,Inc.(NASDAQ:MYGN)haveannouncedtoexpandtheircompaniondiagnostic(CDx)collaborationforenhancingfocusonvariousformsofcancer.
Asperthetermsoftheexpandedcollaboration,thecombinedcompanies’effortswillbeusedtobenefitfromtheBRACAnalysisCDxtest,developedbyUtah-basedMyriad,foridentifyingprospectivepatientsofmetastaticpancreaticcancerwhocouldpotentiallyrespondtotreatmentwithAstraZeneca’sLynparza.
Lynparza,alsoknownbyitschemicalnameolaparib,worksasanorallyactivePARP(poly-ADPribosepolymerase)inhibitorandtargetsthedeficienciesofDNArepairpathwayofvarioustumorsinordertokilltumorcells.OlaparibwasfirstapprovedbytheUSFoodandDrugAdministration(FDA)inDecemberlastyear,asafirst-linemonotherapyoptionforwomensufferingfromdeleteriousgermlineBRCA-mutated(gBRCAm)formofadvancedovariancancer,whohadalsoreceivedthreeormorepriortherapies.
ToadvancethesuccessofitsfirsteverPARPinhibitortobeapprovedbytheFDA,AstraZenecahasbeentryingtoexpanditslabelforvariousindicationsincludingthemostdeadlycancers;thecompanycurrentlyhaslate-stagetrialsunderwayfortestingtheregimen’sefficacyfortreatingBRCA-mutatedpancreaticcancer,adjuvantandmetastaticBRCA-mutatedbreastcancers,aswellassecond-linegastriccancer.
ThecurrentexpansionincollaborationwithMyriadisexpectedtoboostthesuccessofAstraZeneca’sLynparzaintheareaofpancreaticcancer.Currentlyalmost48,000newcasesofpancreaticcancerarediagnosedeachyear,withapproximately40,000patientsdyingannuallyfromthedebilitatingformofcancerintheUSalone.
MarkCapone,presidentatMyriadGeneticLaboratories,seemedpositiveabouttheexpandedcollaborationwithAstraZeneca,saying:"Pancreaticcancerisoneofthefewcancersforwhichsurvivalhasnotimprovedsubstantiallyinthelast40years,andtheaveragelifeexpectancyafterdiagnosiswithmetastaticdiseaseisthreetosixmonths.OurcollaborationwithAstraZenecaisabigstepforwardinthefightagainstpancreaticcancerandinensuringthatpersonalizedmedicinebecomesreality.BRACAnalysisCDxhasthepotentialtoquicklyandaccuratelyidentifythosepatientswhomaybecandidatesfortreatmentwithLynparzaandhopefullytoacceleratebetterhealthoutcomes,"asperthepressreleasebythecompanyonWednesday.
Myriad’sBRACAnalysisCDxwasfirstapprovedinDecemberlastyeartobeusedasacompaniondiagnosticforLynparzainovariancancerpatients.Itbecamethefirstevercomplexlaboratorydevelopedtest(LDT)tobeapprovedbytheFDAunderapre-marketapprovalapplicationprocess.ThiswasalsothefirstregulatoryapprovalforanyLDTCDxtest.BRACAnalysisCDxworksasanin-vitrodiagnosticdeviceandusesgenomicDNAtakenfromwholebloodsamplestoidentifyvariousformsofBRCA1andBRCA2genes.
AstraZenecasharestradedup0.53%tocloseat$68.79onWednesday.Myriadstock,ontheotherhand,wasdown1.78%andclosedat$34.77yesterday.
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