最值得关注的肿瘤药物预测 ASCO 2026 关键启示 Oncology Drugs to Watch Top takeaways from ASCO 2026

OncologyDrugstoWatch

ToptakeawaysfromASCO2026

Contents

03Introduction

04Methodologyandcontributors

06KeyASCO2026takeaways

07PerioperativeErleadaimproves

pathologicalresponseandMFSinhigh-risklocalizedprostatecancer

08AdjuvantRetevmoimprovesEFSin

resectableRET-positiveNSCLC

09STRIDE-basedcombinationschallengeTACEaloneinunresectableeeHCC

10TALAPRO-3strengthensthePARPinhibitorparadigminHRR-mutatedmHSPC

11PersevERAmissesprimaryPFSendpointinfirst-lineER-positive/HER2-negativemetastaticbreastcancer

12Switchingtocamizestrantatemergent

ESR1mutationsignificantlyimprovesPFS2infirst-lineHR-positive/HER2-negative

breastcancer

13Incyte’sMonjuvi/Minjuvi+R2-CHOP

extendsPFSinfrontlineDLBCL

14Mezigdomideincombinationwith

KyprolisanddexamethasonesignificantlyimprovesPFSinrelapsedorrefractorymultiplemyeloma

15DaraxonrasibshowsunprecedentedOSbenefitinpreviouslytreatedmetastaticpancreaticductaladenocarcinoma

16RybrevantFasprodemonstratespivotal

efficacyinlater-lineHPVunrelatedrecurrentormetastaticSCCHN

17KeyASCOtakeawaysfromMainlandChina

18YidafangpluschemotherapydemonstratesOSsuperiorityoverPD-1backbone

infirst-linesquamousNSCLC

19Zegfrovyoutperformschemotherapyinfirst-lineEGFRexon20insNSCLC

20References

Introduction

Newtargets,maturingmodalitiesandhopeforhard-to-treatcancersatASCO2026

Thisyear’sannualmeeting

oftheAmericanSocietyofClinical

Oncologistswassetagainstajarring,ifincreasinglyfamiliar,backdrop–

ontheonehand,enormousdisruptiontothefundingofpreclinicalresearchthatcouldjeopardizefutureadvances;ontheother,tremendous

developmentsthatpromisetogivecancerpatientsmoretimewiththeirlovedones.

Theemotionalhighpointofthisyear’sconferencewas,bymostaccounts,

thestunningresultsfromtheRASolute302trial,whichshowedthatRevolutionMedicines’RAS(ON)multi-selective

inhibitordaraxonrasibnearly

doubledsurvivalinpatients

withbothRAS-mutantand

RAS-wild-typemetastaticpancreaticductaladenocarcinoma(mPDAC),withfewersideeffects

thanchemotherapy,thecurrent

standardofcare.Thatread-out,

whichdrewastandingovation

fromattendees,represented

ahugeleapforwardinthetreatmentofanotoriouslydifficult-to-treat

cancer–and,asBioWorldnotes,itwasnottheonlyray

ofhopeforpancreaticcancer

patientspresentedattheconference.

Astheydoeachyear,Clarivate

oncologyanalystsporedover

abstractsofthepresentationsto

selectthosewiththegreatestimpactonthefield.Thisyear’slistincludestendrugswithglobalimplications

aswellastwoadditionalmoleculesfromMainlandChina,reflecting

thepaceofmedicalinnovationthere.

Thisyear’slistreflectscontinued

movementbeyondimmune

checkpointinhibitors,featuring

innovativetreatmentsbeingtestedagainstlungcancer,headandneckcancer,breastcancer,multiple

myeloma,lymphomaandmore.

"ASCO2026highlightedaclear

diversificationoftherapeutictargets,withgrowingmomentumbehindnovelpathways(beyondimmunotherapies),next-generationADCs,bispecifics,

andrationalcombinationstrategies

reshapingtheoncologymarketlandscape"

LeenaKathuria,

SeniorManager,HealthcareResearchandDataAnalytics.

Methodology

Howweidentifiedthekeyabstractsandtrendsatthe2026ASCO

AspartofourDrugstoWatch

program,Clarivateoncology

expertssiftedthroughmore

than7,000abstractspresented

orpublishedatthe2026ASCO

AnnualMeeting,analyzingthe

dataandperformingaqualitativeassessmenttoshortlistthose

releasesexpectedtohave

asignificantimpactonthecancertreatmentlandscape(noClarivatecustomer-providedinformation

wasusedinthemakingofthis

report).Inaddition,Clarivate

Asia-Pacificoncologyexperts

identifiedkeyhighlightsforresultspresentedfromMainlandChina.Thisreportprovidesanin-depthanalysisofgroundbreakingor

notableclinicaltrialdatareleasesacrossoncologyindications.

Weshortlistedtheseabstractsbasedon,butnotlimitedto,thefollowingcriteria:

•Unprecedentedefficacybenefitovercurrenttherapies

•Clinicaltrialsaddressing

unmetneedinanunderservedpatientpopulation

•Impactoncompetitivelandscapeandmarketdynamics

•Impactontheoncologydrugpipeline

•Noveldrugclassor

combinatorialapproach

Contributors

BoyaZhang

Analyst,ChinaIn-Depth

CarmoCastilhoSoares

Analyst,Oncology

CatherineWilloughby

Analyst,Oncology

CharlotteJago

SeniorAnalyst,Oncology

EstherCoronado

Analyst,Oncology

GlendaWalker

SeniorAnalyst,Oncology

HippolytePaysant

Analyst,Oncology

JoanTur

SeniorAnalyst,Oncology

JuliaMorris

Analyst,Oncology

KhurramNawaz

SeniorManager,Oncology

LauraRamos

SeniorAnalyst,Oncology

LeenaKathuria

SeniorManager,Oncology

LouisPerdios

Manager,Oncology

PragatiTripathi

Analyst,Oncology

RachelWebster

Director,Oncology

RuchitaKumar

SeniorManager,ChinaIn-Depth

SarvenduKumar

Manager,Oncology

SudhaMalhotra

LeadAnalyst,Biopharma

Stayontopofthefast-movingoncologylandscapeandmakedata-drivendecisions

Clarivatehelpslifesciencecompaniesnavigatepipelineplanningwithexpertinsightsandforecastingacross40+tumortypes.LearnmoreaboutDRGDiseaseLandscape&Forecastreportsandspeaktoanexperthere:

Forecastthefutureofoncology|Clarivate

KeyASCO2026takeaways

7

8

1.PerioperativeErleada

improvespathologicalresponseandMFSinhigh-risklocalized

prostatecancer1-2

PROTEUSprovidesthefirstpositivephase3evidenceforARPI-basedintensificationaroundprostatectomy,butendpointinterpretationandmodesteffectsizeleave

itspractice-changingpotentialcontested.

Context

High-risklocalizedprostatecancerremainsassociated

withasubstantialriskofrecurrencedespitecurative-intenttreatment.Currentmanagementincludesradiotherapywithlong-termandrogendeprivationtherapy(ADT)orradicalprostatectomyalone,butsystemicintensificationhasnotbeenestablishedforpatientsundergoing

surgery.Buildingontheprovenbenefitofandrogenreceptorpathwayinhibitors(ARPIs)inadvanceddisease,thephase3PROTEUStrial

evaluatedneoadjuvantandadjuvantErleadaplusADTinpatientsundergoingradicalprostatectomy.ThefirstanalysisfromthetrialwaspresentedatASCO20261andsimultaneouslypublished

inTheNewEnglandJournalofMedicine.2

KeyASCOfindings

Atamedianfollow-upof61.7

months,PROTEUSmetboth

co-primaryendpointswith

perioperativeErleadaplusADTversusperioperativeADTalone:

pathologicalcompleteresponse(pCR)orminimalresidualdisease(MRD)wasachievedin8.9%vs.

1.0%ofpatients(oddsratio10.17;P<0.001),andmetastasis-free

survival(MFS)byconventional

imagingorPSMAPETwas

significantlylonger(5-yearMFS

rates78.2%vs.73.5%;HR0.80;

P=0.02).However,MFSassessedbyconventionalimagingalonewasnotsignificantlyimproved(HR0.84;P=0.15).KeysecondaryendpointsfavoredErleada,includingevent-

freesurvival(57.1vs.38.4months;HR0.71;P<0.001),timetofirst

subsequenttreatment(74.2

vs.41.5months;HR0.65;

P<0.001),andtimetodistantmetastasis(HR0.68;P<0.001).Grade3/4treatment-related

adverseevents(TRAEs)weremorefrequentintheErleadagroup(27.5%vs.18.9%),drivenlargelybyrash,andtreatment-relatedfataladverseevents

occurredin0.7%vs.0.1%ofpatients.

Marketimpact

ClarivateexpectsJohnson&Johnsontoseekapprovalforperioperative

ErleadaplusADTandanticipates

itwillbecomeanewstandard

ofcareforpatientsselectingsurgicalmanagement.Thatpositioning,

however,istemperedbythemodestmagnitudeoftheMFSbenefit

anditsdependenceonPSMA

PET–detectedevents—

anendpointnotyetvalidated

asanOSsurrogate,unlike

conventional-imagingMFS

(whichwasnotsignificantly

improvedinthistrial).Inaddition,

thecontrolarmusedperioperativeADTratherthanthesurgical

standardofprostatectomyalone,

andtheabsolutepCR/MRDrate

remainedbelow10%despitealargerelativeimprovementovercontrol.Therefore,ifapproved,uptakeis

likelytoconcentrateamongfit,

very-high-risksurgicalcandidates,wherethehighestabsolute

recurrenceriskmakesthemodestbenefitmostworthwhile,

whileradiotherapyplusADT

andprostatectomyfollowed

byselectivesalvageradiotherapywilllikelyremainkeyalternatives.

9

2.AdjuvantRetevmo

improvesEFSinresectable

RET-positiveNSCLC3-5

Clarivateexpectsthisdatawillsecureregulatoryapprovalsandbepracticechanging.

Context

Early-stageNSCLCistreatedwherepossiblewithcurative-intent

resectionplus[neo]adjuvantchemotherapyplusappropriatemutation-targetedagentsorimmunotherapy.Althoughtargetedagents

areavailableforEGFR-andALK-positivedisease,andimmune

checkpointinhibitorsforwild-typedisease,notargetedagentsare

currentlyapprovedforearly-stageNSCLCwithRETfusions.Thephase3LIBRETTO-432trialinstageIB-IIIANSCLCassessedadjuvanttreatmentwiththeRETinhibitorRetevmo,whichiscurrentlyapprovedforRET-

positivemetastaticNSCLC.InFebruary2026,EliLillyreportedthatRetevmometitsEFSprimaryendpointinLIBRETTO-432;5detaileddatawererevealedatASCO2026andsimultaneouslypublished.

KeyASCOfindings

Theinvestigator-assessedEFSrate

at24monthsinthestageII-IIIA

primaryanalysispopulationwas91.5%forRetevmoversus61.1%forplacebo(HR0.17,P=0.0003).MedianEFS

wasNRversus31.8months.

IntheoverallstageIB-IIIApopulation,24-monthEFSratewas93.8%versus69.6%(HR0.17,P=0.0002).OSdatawereimmature,withnodeaths

intheRetevmogroup(n=54)versusthreeintheplacebogroup(n=55).Theincidenceofgrade≥3AEs,

seriousAEs,andAEsleading

todiscontinuationwas66.7%

versus23.7%,22.7%versus13.2%,and17.3%versus1.3%,respectively.TherewerenofatalAEs.

Marketimpact

RET-positiveNSCLC,

whichrepresentsapproximately

1-2%ofnonsquamouscases,

isoneofthemanybiomarker-

definedpopulationswithinNSCLC–ahighlyprevalentdiseasewheretargetedtreatmentisthestandardofcareinmanysettings.

Clarivateexpectstheimpressive

EFSimprovementshown

inLIBRETTO-432inresectable

RET-positiveNSCLCtosecure

Retevmo’sapprovalandtobe

practicechanginginthispatient

population.Clarivatedoesnot

expectRetevmotofacecompetitionfromotherRETinhibitorsinthe

resectablesettingduringour

forecastperiod.However,

theidentificationofeligiblepatientsbyusingbiomarkertest,whichisnotyetuniversalinreal-worldpractice,willbecrucialforthedrug’suptake.

10

3.STRIDE-basedcombinationschallengeTACEalonein

unresectableeeHCC6-7

STRIDE±LenvimaplusTACEcoulddiversifytreatmentoptionsbeyondTACEaloneforthefirsttimeinthissetting.

Context

Transarterialchemoembolization(TACE)hasbeenthestandard

ofcareforunresectableembolization-eligiblehepatocellular

carcinoma(eeHCC),butmedianprogression-freesurvival(PFS)

typicallyisaround8to10monthsonly.Afterrepeatedphase3failurescombiningTACEwithimmunotherapy,itsrolehasremainedlargelyunchangedformorethantwodecades.Followingtheimproved

survivalobservedwiththeSTRIDEregimen(singletremelimumabregularintervaldurvalumab)inadvancedHCC(HIMALAYAtrial),7EMERALD-3investigateswhetheraddingSTRIDEwithorwithoutLenvimatoTACEextendsdiseasecontrolinunresectableeeHCC.

KeyASCOfindings

STRIDE+TACE+Lenvima(armA)improvedPFSversusTACEalone

(armC)(median13.0vs9.8months;HR0.70;p=0.007).AlthoughSTRIDE+TACE(armB)wasnotformally

testedinthisanalysis,itdeliveredasimilarPFSimprovement(12.9vs8.1months;HR0.71;p=0.0062).Early

OSdata(40–45%maturity)showedafavorabletrendforarmA(39.5vs34.7months;HR0.84;p=0.18),

whileOShasnotyetbeenreachedwitharmB(HR0.70).Objective

responserates(ORR)inboth

combinationarmsAandBwere

respectively38.9%and40.8%,

versus27%witharmC.Whilesafetywasconsistentwithknowndrug

profiles,treatmentdiscontinuationduetoadverseeventswas

substantialwithSTRIDEcontainingapproaches,particularlyintripletarm(35.5%forarmAand20.6%

forarmB).

Marketimpact

EMERALD-3isthefirstphase3study

inthissettingtoshowimprovedoutcomesoverTACEaloneaftermultipleprior

negativecombinationtrials,supportingpotentialroleofimmunotherapy-basedregimensinunresectableeeHCC.

ThesedataarelikelytosetSTRIDE+

TACEinapolepositionwithphysiciansmovingeligiblepatientsawayfrom

repeatedTACEtowardearlieruse

ofimmunotherapy-basedcombinations.However,thematureOSdataremainstobeseen,whichiscritical

forcommercialsuccess.

11

4.TALAPRO-3strengthensthePARPinhibitorparadigminHRR-

mutatedmHSPC8-12

TalzennaplusXtandidemonstratesrobustefficacyacrossHRRalterationsbeyondBRCAmutations

Context

Treatmentintensificationhasimprovedoutcomesinmetastatichormone-sensitiveprostatecancer(mHSPC),withpolyADP-ribosepolymerase

(PARP)inhibitorsintroducedasbiomarker-drivenapproaches

inpatientswithhomologousrecombinationrepair(HRR)genealterations.Thephase3AMPLITUDEtrialdemonstratedthatAkeega(niraparib

andabirateronefixed-dosecombination)improvedradiographicprogression-freesurvival(rPFS)inHRR-mutatedmHSPC,10althoughregulatoryapprovalswererestrictedtoBRCA-mutatedpopulationsduetoinsufficientevidenceinnon-BRCAsubgroups.TALAPRO-3evaluatesTalzennaplusXtandiinthissettingandPfizerpreviouslyannouncedthatthestudymetitsprimaryendpoint,11withdetailedefficacyandsafetyresultspresentedatASCO2026.8ThedatawereconcomitantlypublishedintheNewEnglandJournalofMedicine.9

KeyASCOfindings

TalzennaplusXtandisignificantly

improvedrPFScomparedwith

Xtandialone(HR0.481,P<0.0001),

withmedianrPFSnotreachedversus45.8months.Thebenefitwasmore

pronouncedinBRCA-mutated

patients(HR0.368,P<0.0001)

andalsosignificantinthenon-BRCAHRRpopulation(HR0.567,P=0.0022).Overallsurvivaldataremainimmature,withatrendfavoringthecombination(HR0.767,P=0.0905).Thesafety

profilewasconsistentwithPARP

inhibitorclasseffects,withgrade3/4treatment-emergentadverseeventsoccurringin79%ofpatientsversus41%withXTANDIalone.Themostcommongrade≥3adverseevent

wasanemia(51%versus1%);dosereductions(60%)andinterruptions(69%)werefrequent,andtreatmentdiscontinuationoccurredin19%

versus10%ofpatients.8,9,11,12

Marketimpact

VariabilityintreatmenteffectacrossindividualHRRgenealterations

mayinfluenceclinicaladoption,

potentiallyresultinginselecteduseinpatientswithcertainHRRdefects.Overall,TALAPRO-3reinforcestheshifttowardmolecularlyguided

intensificationinmHSPC,withitsimpactultimatelydeterminedbythebreadthoftheapprovedlabelandthebalancebetweenefficacyandtoxicity,particularly

hematologicsideeffects,ina

heterogeneouspatientpopulation.

TALAPRO-3representsameaningfuladvanceinthePARPinhibitor

landscape,addressingakey

limitationofAkeegaby

demonstratingastatistically

significantbenefitinthenon-BRCAHRRpopulation.Clarivate

anticipatesthatthesefindings

couldsupportregulatoryapprovalinHRR-mutatedmHSPC,withPfizerindicatingthatresultsarebeing

discussedwithglobalhealth

authoritiestopotentiallyexpand

thecombination’sexisting

indication5.Thetoxicityprofile

remainsanimportantconsiderationinasettingwherepatientsare

treatedforprolongeddurations;

however,theXTANDIbackbone

offerspracticaladvantages

byavoidingcorticosteroid

useandenablingdosingflexibility,whichmayincreaseclinicaluptake.

12

5.PersevERAmissesprimaryPFSendpointinfirst-line

ER-positive/HER2-negative

metastaticbreastcancer13-16

Roche’sgiredestrantfacesfirst-linemetastaticbreastcancersetback,

despitesuccessinbothadjuvantandlater-linemetastatictreatmentsettings.

Context

Giredestrantisanoralselectiveestrogenreceptordegrader(SERD)beingdevelopedacrossmultipletreatmentsettingsinER-positive

/HER2-negativebreastcancer.Thephase3persevERAtrialtested

giredestrantplusIbranceasfirst-linetreatmentforendocrine-sensitivelocallyadvancedormetastaticdisease,usingthestandard-of-care

letrozoleplusIbranceasthecomparator.However,inMarch2026,

Rocheannouncedthatthistrialdidnotmeetitsprimaryendpoint

ofinvestigator-assessedprogression-freesurvival(PFS)intheoverallpopulation,althoughanumericalimprovementinPFSwasobserved.14TheprimaryefficacyandsafetydatawerepresentedatASCO2026.13

KeyASCOfindings

Atamedianfollow-upof52.2months,giredestrantplusIbrancedidnot

demonstrateastatisticallysignificant

PFSbenefitcomparedwithletrozole

plusIbrance(investigator-assessed

medianPFS:33.1monthsvs28.2

months;HR0.89,P=0.1553),

althoughanumericalimprovement

wasobserved.Thesefindingswere

consistentacrosssubgroups;atrend

towardsgreaterbenefitamongpatientswithoutvisceraldiseasewasnoted.

OSdatawereimmaturebutnot

significantlydifferentbetweenarms

(HR1.03,P=0.7767),withORRand

CBRsimilarbetweengiredestrantplusIbranceandletrozoleplusIbrancearms(ORR:60.2%vs.58.8%;CBR:82.6%

vs.82.1%).Durationofresponse(DOR)wasnumericallylongerwith

giredestrantplusIbrancecomparedwithletrozoleplusIbrance

(38.5monthsvs.30.4months).

Marketimpact

ThefailureofthepersevERAtrial,

alongsidepositivelidERAresults,

signalsashiftforgiredestranttowardearly-stagebreastcancer.Notably,giredestrantisthefirstoralSERD

todemonstrateaclinicallysignificantadjuvantbenefitbasedonphase3lidERAdata,strengthening

itspositioninginearly-stagedisease.

Clarivateanticipatesthatthese

findingscouldimpactRoche’seffortstomovegiredestrant’susetothe

frontlinemetastaticsetting.

However,supportedbythePFS

benefitobservedinthephase3

evERAtrial,aU.S.regulatoryfilingisunderreviewforESR1-mutatedlater-linemetastaticdisease.15

Thesedatahighlightarolefor

giredestrantinendocrine-resistantmetastaticdisease,whereunmet

needremainshighand

differentiationversusexisting

therapiesismoreachievable.

Additionally,thepersevERA

outcomeraisesbroaderquestionsonmechanisticallysimilar

combinationsinthepipeline—mostnotablyAstraZeneca’scamizestrantplusIbrance(SERENA-4);

datareadoutfortheSERENA-4trialisslatedforH22026.16

13

6.Switchingtocamizestrant

atemergentESR1mutation

significantlyimprovesPFS2

infirst-lineHR-positive/HER2-

negativebreastcancer17-22

SERENA-6showsthatswitchingtocamizestrantuponemergingESR1mutationextendsbenefitbeyondfirstprogression,improvingprogression-freesurvival2(PFS2),withOSstillimmature.

Context

AcquiredESR1mutationsareaprincipaldriverofresistancetoaromataseinhibitors(AI)inHR-positive/HER2-negativeadvancedbreastcancer.

SERENA-6evaluatedactDNA-guidedstrategyinwhichpatientswithoutdiseaseprogressiononfirst-linearomataseinhibitorplusCDK4/6

inhibitorwhodevelopedanemergentESR1mutationonserialctDNAmonitoringwererandomised,priortoclinicalprogression,toeither

switchtheendocrinebackbonetocamizestrant(anext-generationoralSERD)withcontinuedCDK4/6inhibition,ortocontinuearomatase

inhibitorplusCDK4/6inhibitor.TheprimaryPFSendpointwasmetatapre-plannedinterimanalysisandfirstpresentedatASCO2025,withthecamizestrantswitchsignificantlyimprovinginvestigator-assessedPFS(HR0.44).18,19AmorematuredatasetaddingthefinalprespecifiedPFS2analysis(January2026;thirddatacutoff,DCO3)wasreviewedbytheFDA'sOncologicDrugsAdvisoryCommittee(ODAC)onApril30th,2026,andwasalsopresentedatASCO2026.

KeyASCOfindings

Atamedianfollow-upof23.5months,thecamizestrantswitchsignificantlyimprovedPFS2(keysecondary

endpoint)definedasthetime

fromrandomisationtoprogression

onthefirstsubsequenttherapy

ordeath(25.7vs.19.1months;HR

0.63,P=0.0037);endocrine-based

therapywasthemostcommonfirst

subsequenttreatmentinbotharms.

TheprimaryPFSbenefitwas

maintainedwithlongerfollow-up(16.8vs.9.2months;HR0.45,P<0.00001).OSremainedimmature(~30%of

events)andshowednear-identicalmedianOSbetweenarms(41.2vs40.2months;HR0.87).

Marketimpact

inhibitor—anapproachnotyetembeddedinroutinepractice.

Inthemeantime,theaddressable

oral-SERDmarketfortheESR1-

mutantpopulationremains

concentratedinsecondline,whereOrserdu(Menarini)andtherecentlyapprovedInluriyo(EliLilly)competedirectly.Forcamizestrant,theclearestroutetoblockbusterstatus

increasinglyrestsontheall-comersfirst-lineSERENA-4readout,

whichtargetsthefarbroadertreatment-naïvepopulationregardlessofESR1status.

AlthoughSERENA-6metitsprimary

PFSendpoint,theFDA'sODACvoted6–3inApril2026againstaclinically

meaningfulbenefitfromswitching

tocamizestrantatmolecular

progression,citingaconfoundedPFS2gainandimmatureOS.20TheFDA

hassinceextendeditsreviewtoassessadditionaldata;22theE.U.hastakenamorefavorableview,withapositiveCHMPopinionannouncedinMay

2026.21However,ifapproved,uptakemaybeconstrainedbytheneedforcommunityoncologiststoperform

serialctDNAtestingevery2–3monthsinclinicallystablepatientsonfirst-linearomataseinhibitorplusCDK4/6

14

7.Incyte’sMonjuvi/Minjuvi

+R2-CHOPextendsPFSinfrontlineDLBCL23-27

Tafasitamab+R2-CHOPcouldprovideanewtreatmentavenueforcertainpatientswithpreviouslyuntreatedDLBCL.

Context

NewlydiagnoseddiffuselargeB-celllymphoma(DLBCL)istypicallytreatedwithR-CHOPorpola-R-CHP,whicharecurativeforover60%ofpatients,however,significantunmetneedremainsforthose

withhigh-riskdisease.Monjuvi/Minjuvi(tafasitamab)isaCD19-

targetingmonoclonalantibodyapprovedforthetreatmentofR/RFLandR/RDLBCL.InJanuary2026,Incyteannouncedpositivetoplineresultsfromtheglobalphase3frontMINDstudyexploringfrontline

tafasitamabuseinhigh-intermediate-andhigh-riskDLBCLpatients.24InvestigatorsrevealedinitialefficacyandsafetyresultsatASCO2026,23andthesedatawerepublishedsimultaneouslyinTheLancet.25

KeyASCOfindings

Theadditionoftafasitamaband

lenalidomidetoR-CHOPsignificantlyimprovedPFS(primaryendpoint,HR0.75,P=0.0194,3-yearPFSrate:67.3%vs.60.7%)andEFS(HR0.79,P=0.0260,3-yearEFSrate:61.2%vs.54.8%)

comparedwithR-CHOPaloneinnewlydiagnosedDLBCLorHGBCLpatientswithIPI3-5(orage-adjustedIPI2-3).

HazardratiossupportingthisPFS

benefitwereobservedacrossABC-like,GCB-like,andunclassifiedcell-of-originsubgroups(HR0.59,0.69,and0.58,

respectively).Interimanalysis

demonstratedapositiveOStrendfavoringtafasitamab+R2-CHOP(HR0.85,P=0.2703,3-yearOSrate:

81.5%vs.77.8%).TheORRatthe

endoftreatmentwasnumerically

higherwithtafasitamab+R2-CHOP

(80.4%vs.76.2%),howeverthePET-

negativecompleteresponses(CR)ratewas65.2%inbothtreatmentarms.

Tafasitamab+R2-CHOPwas

associatedwithincreasedrates

ofgrade≥3treatment-emergent

adverseevents(TEAEs)(86.7%vs.

76.1%),seriousTEAEs(50.1%vs.

38.9%),andfatalTEAEs(5.9%vs.3.8%).

Marketimpact

frontMINDachievedcomparableresultstothelandmarkPOLARIXstudy,26

inwhichpola-R-CHPdemonstratedaPFSbenefit(HR0.77)andapositiveOStrend(HR0.85)versusR-CHOPin

previouslyuntreatedDLBCLpatientswithIPI2-5.IncytehasannounceditsintentiontofileansBLAfortafasitamab+R2-CHOPinQ22026,27however,

regulatorswilllikelyquestionwhethertheincreasedrateofseriousAEsmeritsthelimitedsurvivalbenefits,especiallygiventheavailabilityofpola-R-CHP

inthispopulation.Tafasitamab+

R2-CHOPcouldprovidean

alternativetreatmentinfirst-line

DLBCL,particularlyforpatients

withGCB-likedisease(whoderiveminimalbenefitfrompola-R-CHP),26forfitpatientswhocantolerate

amoreintenseside-effectprofile,

orincountrieswherePolivyisnot

widelyavailable.However,concernsaboutthebenefit-riskratio,frontlineuseofananti-CD19agentpotentiallyrestrictinguseofCD19-targeting

CARTcellsinlatertreatmentlines,andtheschedulingcomplexities

ofadministeringthis7-drugregimencouldlimitprescribing.Clarivate

envisagesthat,withoutacompellingOSbenefit,thisregimenisunlikelytogarnersubstantialuptake

ordisplaceR-CHOPasthemainstayoffrontlineDLBCLtreatment,

particularlygiventheimminentcompetitionanticipatedfrom

T-cell-engagingbispecificantibodiesinthissetting.

15

8.MezigdomideincombinationwithKyprolisanddexamethasonesignificantlyimprovesPFS

inrelapsedorrefractory

multiplemyeloma28-31

Positiveinterimresultsfromthepivotalphase3SUCCESSOR-2trialsupportsMezi-Kdforpotentialregulatoryfiling.

Context

MezigdomideisanoralcereblonE3ligasemodulation(CELMoD)agentbeingdevelopedbyBristolMyersSquibb(BMS).29MezigdomideispartofBMS’slifecyclemanagementstrategytoreplaceImnovid/Pomalyst

inrelapsedorrefractorymultiplemyeloma.Thephase3SUCCESSOR-2trialisevaluatingmezigdomideincombinationwithKyprolisand

dexamethasone(Mezi-Kd)versusKyprolisanddexamethasone(Kd).

InMarch2026,BMSannouncedthattheSUCESSOR-2trialmetitsprimaryendpointofPFS.30DatawerepresentedforthefirsttimeatASCO2026.28

KeyASCOfindings

AmedianPFSof18.0months

wasobservedwithMezi-Kdversus

8.3monthswithKd(HR0.48,

P<0.0001).Atthetimeofthisinterimanalysis,OSdatawereimmature;

however,atamedianfollowupof

10.6months,apositiveOStrendwasobservedfavoringMezi-Kd(HR0.79).Additionally,PFSwassignificantly

improvedacrossallprespecified

subgroups,includingpatients

refractorytoanti-CD38monoclonalantibodiesandlenalidomide.

TheoverallsafetyprofileofMezi-Kdwasconsistentwithprevious

mezigdomidestudies.Therewerehigherratesofgrade3/4TEAEsintheMezi-Kdarmcompared

toKd(83.7%vs.56.5%).

Marketimpact

DespitepositiveinterimPFSdata,

thetrial’sdesignmaybeconsidered

controversialduetotheuseofKd

asthecontrolarm,comparinga

tripletversusadoubletregimen.

Inaddition,Kdisnotlistedasa

preferredregimeni