SCI

23January

UpdatedOverallSurvivalandPD-L1SubgroupAnalysisofPatientsWithExtensive-StageSmall-CellLungCancerTreatedWithAtezolizumab,Carboplatin,andEtoposide(IMpower)

CORRESPONDINGAUTHOR：StephenV.Liu,MD,LombardiComprehensiveCancerCenter,GeorgetownUniversity,ReservoirRoadNW,Washington,DC;Twitter:

LiuSV,ReckM,MansfieldAS,etal.UpdatedOverallSurvivalandPD-L1SubgroupAnalysisofPatientsWithExtensive-StageSmall-CellLungCancerTreatedWithAtezolizumab,Carboplatin,andEtoposide(IMpower).JClinOncol:Jco.

IMpower(ClinicalTrials.govidentifier:NCT),arandomized,double-blind,phaseI/IIIstudy,demonstratedthataddingatezolizumab(anti-programmeddeath-ligand1[PD-L1])tocarboplatinplusetoposide(CP/ET)forfirst-line(1L)treatmentofextensive-stagesmall-celllungcancer(ES-SCLC)resultedinsignificantimprovementinoverallsurvival(OS)andprogression-freesurvival(PFS)versusplaceboplusCP/ET.UpdatedOS,diseaseprogressionpatterns,safety,andexploratorybiomarkers(PD-L1,blood-basedtumormutationalburden[bTMB])arereported.

IMpower（ClinicalTrials.gov标识符：NCT）是一项随机，双盲I/III期研究，证明将阿特珠单抗（抗编程死亡配体1[PD-L1]）添加到卡铂加依托泊苷（CP/ET）中与安慰剂加CP/ET相比，广泛期小细胞肺癌（ES-SCLC）的一线治疗显着改善了总生存期（OS）和无进展生存期（PFS）。并报道了最新的OS，疾病进展模式，安全性，探索性生物标志物（PD-L1，基于血液的肿瘤突变负担[bTMB]）。

PatientswithuntreatedES-SCLCwererandomlyassigned1:1toreceivefour21-daycyclesofCP(areaunderthecurve5mgpermL/minintravenously[IV],day1)plusET(mg/m2IV,days1-3)withatezolizumab(1,mgIV,day1)orplacebo,andthenmaintenanceatezolizumaborplacebountilunacceptabletoxicity,diseaseprogression,orlossofclinicalbenefit.Tumorspecimenswerecollected;PD-L1testingwasnotrequiredforenrollment.Thetwoprimaryendpoints,investigator-assessedPFSandOS,werestatisticallysignificantattheinterimanalysis.UpdatedOSandPFSandexploratorybiomarkeranalyseswereconducted.

未经治疗的广泛期SCLC患者被随机分配为1：1接受四个21天周期的卡铂（曲线下面积5mg/mL/min[IV]，第1天）加上ET（mg/m2IV，天）1-3）与阿特珠单抗（1,mgIV，第1天）或安慰剂，然后维持atezolizumab或安慰剂，直到出现不可接受的*性，疾病进展或失去临床益处为止。收集肿瘤标本，而且PD-L1试验不需要招募。在中期分析中，研究者评估的PFS和OS这两个主要终点在统计学上显着。并进行了更新的OS和PFS以及探索性生物标志物分析。

PatientsreceivedatezolizumabplusCP/ET(n)orplaceboplusCP/ET(n).Attheupdatedanalysis,medianfollow-upforOSwas22.9months;deathshadoccurred.MedianOSwas12.3and10.3monthswithatezolizumabplusCP/ETandplaceboplusCP/ET,respectively(hazardratio,0.76;95%CI,0.60to0.95;descriptiveP5.).At18months,34.0%and21.0%ofpatientswerealiveinatezolizumabplusCP/ETandplaceboplusCP/ETarms,respectively.Patientsderivedbenefitfromtheadditionofatezolizumab,regardlessofPD-L1immunohistochemistryorbTMBstatus.

患者接受阿特珠单抗加CP/ET（n）或安慰剂加CP/ET（n）。在最新的分析中，OS的中位随访时间为22.9个月。发生了人死亡。阿特珠单抗加CP/ET和安慰剂加CP/ET的中位OS分别为12.3和10.3个月（危险比，0.76；95％CI，0.60至0.95；描述性P=.）。在18个月时，阿特珠单抗加CP/ET和安慰剂加CP/ET组的存活率分别为34.0％和21.0％。无论PD-L1免疫组织化学或bTMB状况如何，患者都可从添加阿特珠单抗中获益。

AddingatezolizumabtoCP/ETas1LtreatmentforES-SCLCcontinuedtodemonstrateimprovedOSandatolerablesafetyprofileattheupdatedanalysis,confirmingtheregimenasanewstandardofcare.Exploratoryanalysesdemonstratedtreatmentbenefitindependentofbiomarkerstatus.

在CP/ET将阿特珠单抗作为ES-SCLC的一线治疗剂，在更新后的分析中继续证实了改善的OS和可耐受的安全性，从而确认该方案是新的治疗标准。探索性分析表明，治疗益处与生物标志物状态无关。

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