ASCO 2024關(guān)鍵啟示 最值得關(guān)注的腫瘤藥物預(yù)測

ASCO2024關(guān)鍵啟示2引言4方法學(xué)5存期(PFS)1,3-52.英飛凡鞏固治療可延長接受同步放化療的局限期SCLC患者的生存期6,783.新輔助治療藥物歐狄沃?聯(lián)合逸沃?可改善可切除III期惡性黑色素瘤患者的無事件生存期10,1194.優(yōu)赫得?在激素受體陽性、HER2低表達(dá)和HER2超低表達(dá)乳腺癌患者接受內(nèi)分泌治療后展現(xiàn)出PFS獲益14105.唯擇?聯(lián)合氟維司群可改善HR+、HER2陰性、既往接受CDK4/6抑制劑治療后出現(xiàn)疾病惡化的乳腺癌患者的PFS17116.歐狄沃?聯(lián)合逸沃?可延長一線治療晚期肝細(xì)胞癌患者的總生存期(OS)21127.Lumakras聯(lián)合Vectibix在延長既往接受過治療的KRASG12C突變轉(zhuǎn)移性結(jié)直腸癌患者的總生存期(OS)方面表現(xiàn)出良好趨勢23138.BLENREP?在復(fù)發(fā)或難治性(骨髓瘤治療中重獲關(guān)注26,271439.Adcetris聯(lián)合來那度胺和利妥昔單抗可延長復(fù)發(fā)/難治性DLBCL患者的總生存期(OS)281510.SCEMBLIX?在治療新診斷的CML慢性期患者中展現(xiàn)出優(yōu)于標(biāo)準(zhǔn)TKI的療效和安全性30,3116中國大陸ASCO2024的關(guān)鍵啟示171.首創(chuàng)亞型選擇性HDAC抑制劑愛譜沙?在初治DLBCL中展現(xiàn)出卓越療效34172.KRASG12C抑制劑成為中國大陸不可切除KRAS突變NSCLC治療領(lǐng)域的突破35183.Suvemcitug均可延長鉑耐藥卵巢癌患者的無進(jìn)展生存期(PFS)，不受先前藥物使用的影響41194.Sacituzumabtirumotecan可顯著改善既往接受過多種治療的轉(zhuǎn)移性三陰性乳腺癌患者的PFS45205.艾瑞恩?聯(lián)合多西他賽在轉(zhuǎn)移性激素敏感性性前列腺癌治療中展現(xiàn)出良好的應(yīng)用潛力4721參考文獻(xiàn)224人士參加，會議的總體基調(diào)是，腫瘤學(xué)這一藥物研發(fā)重點領(lǐng)域正在飛速前進(jìn)，并越來越靈活地運用新舊抗癌技術(shù),治療手段日臻成熟。今年的主題是“癌癥治療的“某些癌癥的數(shù)據(jù)非常好，以至于正在逐漸成為一種慢性疾病，”科睿唯安產(chǎn)品管理副總裁Ketan佳治療劑量、方案和組合，以期在治療期間和治療后真正幫助癌癥患者獲得良好的生活質(zhì)量?！币饬x。這些值得關(guān)注的腫瘤藥物涵蓋了諸多公司、適應(yīng)癥和治療方式，包括抗體藥物偶聯(lián)物、一系列將現(xiàn)有藥物標(biāo)簽擴展到新的治療方案領(lǐng)域蘊藏著巨大潛力?！?我們?nèi)绾卧?024年ASCO年會上確定關(guān)鍵摘要和趨勢在最值得關(guān)注的藥物預(yù)測(DrugstoWatchTM)項目中，科睿唯安腫瘤學(xué)專家在2024年ASCO年別了中國大陸研究成果的關(guān)鍵要點。本報告對不同腫瘤適應(yīng)癥的開創(chuàng)性或值得關(guān)注的臨床研究數(shù)據(jù)進(jìn)?針對醫(yī)療資源不足患者人群未被滿足的需求的臨床研究?對競爭格局和市場動態(tài)的影響?對腫瘤藥物研發(fā)線的影響?新穎的藥物類別或聯(lián)合用藥方案AnanyaSadhu，ChinaIn-Depth高級分析師CatherineWilloughby，腫瘤學(xué)分析師CharlotteJago，腫瘤學(xué)高級分析師GlendaWalker，腫瘤學(xué)高級分析師JuliaMorris，腫瘤學(xué)分析師KaranVerma，ChinaIn-Depth首席分析師PragatiTripathi，腫瘤學(xué)分析師SahilArora，ChinaIn-Depth分析師SaurabhVirdi，腫瘤學(xué)首席分析師SudhaSaryuMalhotra，Adhoc高級分析師ThomasPataillot-M66科睿唯安疾病現(xiàn)狀和預(yù)測報告可幫助生命科學(xué)公司優(yōu)化長期疾病戰(zhàn)略，并利用全面的市場情報和可操作的建議驗證預(yù)測。請訪問我們的報告商店或聯(lián)系我們的團隊以7盲法獨立中心評審（blindindependentcentralreview，BICR）顯示，與放化療后安慰劑相比，）：8）；性特征是可控的，與既往報道一致。兩組中，由任何原因?qū)е碌?/4級不良事件發(fā)生率約為24%。93.新輔助治療藥物歐狄沃?聯(lián)合逸沃?可改善可切然而，目前尚無獲批用于惡性黑色素瘤的新輔助治療方案。ASCO2023上公布了OpACIN-neo和PRADO擴展試驗的三年期良好早期病理反應(yīng)數(shù)據(jù)，這試驗評估了可切除III期惡性黑色素瘤患者使用新輔助歐狄沃?聯(lián)合逸沃?。12接著，在ASCO2024首次公布了第三階段NADINA），疲勞和總體）的評分均相似。11輔助治療相比，新輔助治療可以提高無復(fù)發(fā)生存期。12,13N的免疫檢查點抑制劑的競爭中占據(jù)優(yōu)勢?？汕谐褪菒盒院谒亓龌颊咧凶畲蟮娜后w；盡管這項試驗是由學(xué)術(shù)界主導(dǎo)的，但如果百時美施貴寶提交并獲得新輔助用途的標(biāo)簽擴展，那么這種聯(lián)合療法可能會阿斯利康和大塚山口制藥的抗體偶聯(lián)藥物（antibody-drugconjugate，ADC）優(yōu)赫得?是唯一在主既往接受CDK4/6抑制劑治療后出現(xiàn)疾病惡化的內(nèi)分泌治療在二線或后線治療中的療效，結(jié)果喜憂參半。18唯擇?抑制CDK4/6的獲益的3期試驗。ASCO2024公布了該試驗的結(jié)果。17要分析結(jié)果的不一致所示，在整個試驗隊列中，其療效并不大。此外，考慮到聯(lián)合治療方案帶來的毒性增加以及預(yù)計在不久的將來二線治療領(lǐng)域?qū)⒂卸喾N新方案獲批，我們預(yù)計唯擇?聯(lián)合氟維司群在6.歐狄沃?聯(lián)合逸沃?可延長一線治療晚期肝細(xì)胞三階段的CheckMate-9DW試驗在一線晚期疾病的總生存期(O首批結(jié)果在2024年ASCO年會上公布。21,22CheckMate-9DW使用了一種強效對照藥物，即樂也觀察到更高的比率，并且趨向于改善健康相關(guān)生活質(zhì)。雖然兩組中3/4級治療相關(guān)不良事件的發(fā)生尋求其雙重免疫檢查點抑制劑組合的獲批，并將其作為有前景的晚期肝細(xì)胞癌一線治療選擇。隨著預(yù)期的標(biāo)簽擴展，歐狄沃?聯(lián)合逸沃?可能會挑戰(zhàn)當(dāng)前的療法，即泰圣奇?聯(lián)合貝伐單抗和英飛凡聯(lián)合經(jīng)過中位13.6個月的隨訪，與研究者選擇的療法（Lonsurf或拜萬戈）相比，Lumakras（960mg和240mg）加Vectibix顯示出OS改善的趨勢，Lu審查，目標(biāo)日期為2024年6月21。25治療中重獲關(guān)注26,27聯(lián)合療法在至少接受過一線治療的復(fù)發(fā)/難治性多發(fā)性骨髓7和DREAMM-8試驗中，分別有78試驗。然而，在2024年3月，輝瑞在收購Se與單用來那度胺和利妥昔單抗相比，Adcetris聯(lián)合來那度胺和利妥昔單抗顯著提高了復(fù)發(fā)或難治性治療組中觀察到有意義的ORR改善，無論CD30表達(dá)水平如何，這些獲益均一致。但是也在治療組中觀察到更高的3級及以上治療相關(guān)不良事件發(fā)生率(88%vs.77%)。與對照組相比，Adcetris的加入還導(dǎo)致更高的血液學(xué)毒性和任何級別的周圍神經(jīng)病變發(fā)生率(31%vs.24%)。市場中面臨激烈競爭，尤其是來自已獲批的ADC藥物于選擇療效相似但安全性更高、耐受性更好的雙特異性抗體，這將會限制Adcetris費城染色體陽性慢性期慢性粒細(xì)胞白血?。╟hronicmyeloidleukemia，CML）（Ph+CML-CP）醫(yī)學(xué)雜志》。32,33現(xiàn)主要分子學(xué)反應(yīng)（majormolecularresponse，MMR而接受第一代或第二代T級及以上不良事件發(fā)生率（38%）低于伊馬替尼組（44%）或第二代TKI組（55%）。的第三階段試驗。諾華已通過實時腫瘤學(xué)審查程序?qū)⑦@些結(jié)果提交給FDA，這可能會導(dǎo)致1.首創(chuàng)亞型選擇性HDAC抑制劑愛譜沙?在2024年5月，中國國家藥品監(jiān)督管理表達(dá)（約30%的DLBCL病例）的新診斷DLBCL患者。中期結(jié)果已在ASCO2024上公布。34生物的fulzerasib、中國生物制藥的garsorasib和加科思的glecirasib）競爭，這三款藥物的研發(fā)進(jìn)度略微領(lǐng)先，并可能在2025年底之前在中國大陸獲批。目前的臨床證據(jù)表明，所有這些藥物在既suvemcitug在臨床前模型和1b期研究中已顯示出令人鼓舞的抗腫瘤活性和可控的安全性。42,43基于這些結(jié)果，先聲藥業(yè)已向國家藥品監(jiān)督管理局NMPA提交了suvemcitug聯(lián)合化療治療復(fù)發(fā)性鉑耐藥卵巢癌的新藥上市申請。44我們預(yù)計，suvemcitug憑借其令人信服的臨床特征將獲得批準(zhǔn)，但它可能面臨來自貝伐單抗的激烈競爭，因為后者已在這些患者中得到廣泛應(yīng)用，醫(yī)生熟悉度高，并在中國大陸，既往接受過治療的轉(zhuǎn)移性三陰性乳腺癌患者是一個高度未被滿足的患者群體，化療仍然是主要的治療方法。在這種情況下，市場增長完全是由最近上市和使用吉利德/Immunomedics公sacituzumabtirumotecan的商業(yè)權(quán)利持有人）宣布，國家藥品監(jiān)督管理局(NMPA)基于2024年對先前接受治療的轉(zhuǎn)移性三陰性乳腺癌的上市申請。45,46存期(OS)中期分析結(jié)果顯示，sacituzumabtirumotecan如果sacituzumabtirumotecan獲批，其將成為首個在這一高度未滿足需求領(lǐng)域獲得批準(zhǔn)的國產(chǎn)由于大多數(shù)此類療法都旨在在一線治療中獲5.艾瑞恩?聯(lián)合多西他賽在轉(zhuǎn)移性激素敏感性性前令人鼓舞的初步研究結(jié)果表明，艾瑞恩?可能擴展用于轉(zhuǎn)移性激素敏感性性前列腺癌（metastatic轉(zhuǎn)移性激素敏感性性前列腺癌因其晚期和侵襲性的特點，治療難度很大。預(yù)后不良和治療選擇有限是擇激素藥物和/或化療，因為目前仍然缺乏有效的靶向治療。艾瑞恩?已在江蘇恒瑞醫(yī)藥公布了兩組2期臨床試驗的初步研究結(jié)果，這些試驗評估了艾瑞恩?聯(lián)合多西他賽治療生存期（radiographicprogression-freesurvival，rPFS）為10.9個月，12周時的前列腺特異鑒于患者在接受阿比特龍治療后病情出現(xiàn)惡化，這些初步結(jié)果令人鼓舞，但有必要進(jìn)行進(jìn)一步的研究卡魯胺聯(lián)合ADT相比，艾瑞恩?聯(lián)合雄激素剝奪療法（androgen-deprivationtherapy，ADT）1.Tagrissodemonstratedoverwhelmingefficacybenefitforpatientswith(February19,2024).AstraZeneca,[online],availableat:/media-centre/press-releases/2024/tagrisso-improved-pfs-in-stage-iii-lung-cancer.html.(accessedonJune2,2024).2.NaidooJ,AntoniaS,WuY-L,etal.BriefReport:DurvalumabAfterSubgroupAnalysisFromPACIFIC.JournalofThoracicOncology.2023;18(5):657-663.DOI:10.1016/j.jtho.2023.02.009.3.RamalingamSS,KatoT,DongX,etal.Osimertinib(osi)afterdefinchemoradiotherapy(CRT)inpatients(pts)withunresectablestage(stg)IIIepidermalgrowthfactorreceptor-mutated(EGFRm)NSCLC:Primaryresultsofthephase3LAURAstudy.JournalofClinicalOncology.2024;42(17_suppl):LBA4.DOI:10.1200/JCO.2024.42.17_suppl.LBA4.4.Tagrissoreducedtheriskofdiseaseprogressionordeathby84%inpatientswithunresectable,StagePhaseIIItrial(June2,2024).AstraZeneca,[on/media-centre/press-releases/2024/tagrisso-reduced-the-risk-of-disease-progression-or-death-by-84-percent-in-patients-with-unresectable-stage-iii-egfr-mutated-lung-cancer-vs-placebo.html.(accessedonJune2,2024).5.LuS,KatoT,DongX,etal.OsimertinibafterChemoradiotherapyinStageIIIEGFR-MutatedNSCLC.NewEnglandJournalofMedicine.2024Jun2[onlineaheadofprint].DOI:10.1056/NEJMoa2402614.6.Imfinzisignificantlyimprovedoverallsurvivalandprogression-freesurvivalforpatientswithlimited-stagesmallcelllungcancerinADRIATICPhaseIIItrial(April5,2024).AstraZeneca,[online],availableat:/media-centre/press-releases/2024/imfinzi-improved-os-and-pfs-in-limited-stage-sclc.html.(accessedonJune3,2024).7.SpigelDR,ChengY,ChoBC,etal.ADRIATIC:Durvalumab(D)asconsolidationtreatment(tx)forpatients(pts)withlimited-stagesmall-celllungcancer(LS-SCLC).JournalofClinicalOncology.2024;42(17_suppl):LBA5.DOI:10.1200/JCO.2024.42.17_suppl.LBA5.8.Lungcancersurvivalrates(January29,2024).AmericanCancerSociety,[online],availableat:/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html.(accessedonJune6,2024).9.ImfinziapprovedintheUSforextensive-stagesmallcelllungcancer(March30,2020).AstraZeneca,[online],availableat:/media-centre/press-releases/2020/imfinzi-approved-in-the-us-for-extensive-stage-small-cell-lung-cancer.html.(accessedonJune4,2024).10.BlankC,LucasM,ScolyerR,etal.Neoadjuvantnivolumabplusipilimadjuvantnivolumabinmacroscopic,resectablestageIIImelanoma:Thephase3NADINAtrial.JournalofClinicalOncology.2024;42(17_suppl):LBA2.DOI:10.1200/JCO.2024.42.17_suppl.LBA2.11.LucasM,ArokoskiR,MenziesA,etal.Qualityoflifewithneoadjuvantipilimumab(IPI)andnivolumab(NIVO)versusadjuvantnivolumabinresectablestageIIImelanoma:36-weekdatafromthephase3NADINAtrial.JournalofClinicalOncology.2024;42(17_suppl):LBA9584.DOI:10.1200/JCO.2024.42.17_suppl.LBA9584.12.ReijertI,MenziesA,VersluisJ,etal.Theimpactofresponse-directedsurgeryandadjuvanttherapyonlong-termsurvivalafterneoadjuvantipilimumabplusnivolumabinstageIIImelanoma:Three-yeardataofPRADOandOpACIN-neo.JournalofClinicalOncology.2023;41(16_suppl):101.DOI:10.1200/JCO.2023.41.16_suppl.101.ChangesintheAmericanJointCommitteeonCancerEighthEditionCancerStagingManual:MelanomaStaging:AJCC8thEdition.CancerJournalforClinicians.2017;67:472–492.DOI:10.3322/caac.21409.14.CuriglianoG,HuX,DentRA,etal.choiceofchemotherapy(TPC)inpatients(pts)withhormonereceptor-positive(HR+),humanepidermalgrowthfactorreceptor2(HER2)-loworHER2-ultralowmetastaticbreastcancer(mBC)withpriorendocrinetherapy(ET):PrimaryresultsfromDESTINY-Breast06(DB-06).JournalofClinicalOncology.2024;42(17_suppl):LBA1000.DOI:10.1200/JCO.2024.42.17_suppl.LBA1000.15.Enhertudemonstratedstatisticallysignificantandclinicallymeaningfulimprovementinprogression-freesurvivalinHR-positive,HER2-lowmetastaticbreastcancerfollowingoneormorelinesofendocrinetherapyinDESTINY-Breast06PhaseIIItrial(April29,2024).AstraZeneca,[online],availableat:/media-centre/press-releases/2024/enhertu-improved-pfs-in-her2-low-and-ultralow.html.(accessedonJune6,2024).16.ENHERTU?DemonstratedStatisticallySignificantandClinicallyMeaningfulBreastCancerFollowingOneorMoreLinesofEndocrineTherapyinDESTINY-Breast06Phase3Trial(April29,2024).DaiichiSankyo,[online],availableat:/files/news/pressrelease/pdf/202404/20240429_E.p17.KalinskyK,BianchiniG,HamiltonEP,etal.AbemaciclibplusfulvestrantaloneforHR+,HER2-advancedbreastcancerfollowingprogressiononapriorCDK4/6inhibitorplusendocrinetherapy:Primaryoutcomeofthephase3postMONARCHtrial.JournalofClinicalOncology.2024;42(17_suppl):LBA1001.DOI:10.1200/JCO.2024.42.17_suppl.LBA1001.18.KalinskyK,AccordinoTherapyWithorWithoutRibociclibAfterProgressiononCyclin-DependentKinase4/6InhibitioninHormoneReceptor–Positive,HumanEpidermalGrowthFactorReceptor2–NegativeMetastaticBreastCancer:MAINTAINTrial.JournalofClinicalOncology.2023;41(24):4004–4013.DOI:10.1200/JCO.22.02392.19.Llombart-CussacA,Harper-WynneC,PerelloA,etal.Second-lineendocrinetherapy(ET)withorwithoutpalbociclib(P)maintenanceinpatients(pts)withhormonereceptor-positive(HR[+])/humanepidermalgrowthfactorreceptor2-negative(HER2[-])advancedbreastcancer(ABC):PALMIRAtrial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