NSCLC:2025highlights

andeventstowatchin2026

MarketTrendsSummary

CharlotteJago,Ph.D.|December2025

?2025Clarivate.Allrightsreserved.2

2025marksanotherbreakthroughyear

forNSCLCdrugapprovals

23labelsapproved

?2025featured23label

approvalsacrossthemajor

markets,includingnewdrugsandlabelexpansions.

?46targetedtherapies

(excludingchemotherapy

drugs)arenowapprovedforNSCLCinthemajormarkets,including31mutation-

targetedagents,9immunecheckpointinhibitors,3

ADCs,and3angiogenesisinhibitors.

NewSCoptions

?2025sawtheapprovalofthethirdsubcutaneous(SC)

formulationofanimmunecheckpointinhibitor.

?SCformulationsoffermore-convenientdosingthan

intravenousformulations.

?TheSCportfolioofimmunecheckpointinhibitorsin

NSCLCcomprisesKeytruda,Tecentriq,andOpdivo.

Firstoraloptions

?Thefirstoraldrugsfor

patientswithEGFRexon20

insertionmutations(Zegfrovy)andHER2mutations

(HernexeosandHyrnuo)wereapprovedin2025.

?Bothpatientpopulationshadpreviouslybeenservedonlybyintravenousdrugs.

MarketTrendsSummary

NewADCs

?Twoantibody-drug

conjugates(ADCs)gained

approvalin2025forareasofunmetneedinthelater-linemetastaticsettings.Emrelis

fortumorswithhighlevelsofMEToverexpressionand

DatrowayforEGFR-mutatedtumors.

FDAapprovalsforNSCLCin2025MarketTrendsSummary

Hyrnuo

HER2tyrosinekinaseinhibitor

Genomic

alterationpopulation

Broad

populationapplicability

Hyrnuo(sevabertinib)joinsHernexeosasanoral

November

alternativetointravenousEnhertu(trastuzumab

deruxtecan)forlater-linemetastaticHER2-positiveNSCLC

KeytrudaQlex

SC-formulatedPD-1checkpointinhibitor2

KeytrudaQlexisthethirdSCcheckpointinhibitor

September

approvedintheU.S.market,joiningTecentriqHybreza(atezolizumabSC)andOpdivoQvantig(nivolumabSC)

Hernexeos

HER2tyrosinekinaseinhibitor1

Hernexeos(zongertinib)offersthefirstoralalternativeto

August

Market

positioning

intravenousEnhertu(trastuzumabderuxtecan)forlater-linemetastaticHER2-positiveNSCLC

Zegfrovy

EGFRtyrosinekinaseinhibitor

July

Zegfrovy(sunvozertinib)providesthefirstoralalternativetoinjectableRybrevant(amivantamab)forlater-line

metastaticNSCLCwithEGFRexon20insertionmutations

Datroway

TROP2-targetingantibody-drugconjugate

Datroway(datopotamabderuxtecan),thefirstTROP2ADCapprovedinNSCLC,offersalater-lineoptionforEGFR-

positivepatientsafterEGFRTKIsandchemotherapy

June

Ibtrozi

ROS1tyrosinekinaseinhibitor1

Ibtrozi(taletrectinib)joinsRozlytrek(entrectinib)and

Augtyro(repotrectinib)inthearmoryagainstmetastaticROS1-positiveNSCLC

Emrelis

MET-targetingantibody-drugconjugate

May

Emrelis(telisotuzumabvedotin)isthefirstdrugapprovedforlater-linemetastaticnonsquamousNSCLCwithhigh

c-Metproteinoverexpression

?2025Clarivate.Allrightsreserved.3

1.IbtroziandHernexeosgainedJapaneseapprovalinSeptember2025.

2.KeytrudaQlexgainedEuropeanapproval,asKeytrudaSC,inNovember2025.

?2025Clarivate.Allrightsreserved.4

MarketTrendsSummary

Lookingaheadto2026

KeymilestonesandeventstowatchinNSCLC

RegulatorydecisionsareexpectedontwoU.S.NDAfilingssubmittedin2025:

-Nuvalent’szidesamtinibforpreviouslytreatedmetastaticROS1-positiveNSCLC

-CullinanOncologyandTaihoPharmaceutical’szipalertinibforpreviouslytreatedmetastaticNSCLCwithEGFRexon20insertionmutations

KeyconferencesexpectedtofeatureNSCLCdata:

-EuropeanLungCancerCongress(March2026)

-ASCOAnnualMeeting(May-June2026)

-WorldConferenceonLungCancer(September2026)

-ESMOCongress(October2026)

NewdrugsandnewmechanismsofactiontestedinPhase3trialsinthemajormarkets1:

-PF-08046054,Pfizer’sPD-L1-targetingADC,inpreviouslytreatedPD-L1-positivemetastaticNSCLC

-Izalontamabbrengitecan,BristolMyersSquibb’sEGFR×HER3antibody,inpreviouslytreatedEGFR-mutatednonsquamousmetastaticNSCLC

-Ateganosine,MAIABiotechnology’stelomereinhibitor,incombinationwithLibtayoinpreviouslytreatedmetastaticNSCLC

-IBI-363,InnoventBiologics’PD-1×IL-2α-biasantibodyfusionprotein,inpreviouslytreatedsquamousmetastaticNSCLC

-PF-08634404,Pfizer’sPD-1×VEGFantibody,incombinationwithchemotherapyintreatment-naivemetastaticNSCLC

1.BasedonClinicalTrecords(asofDecember1,2025).

?2025Clarivate.Allrightsreserved.5

Abouttheauthor

MarketTrendsSummary

CharlotteJago,Ph.D.

SeniorHealthcareResearch&DataAnalystDRGCommercialSolutions

CharlotteJagoisapharmaceuticalindustryanalystwithmorethan20years'experience,precededby5yearsoflaboratoryresearchinacademiaand

industry.Shewrotethecompany’sflagshipDrugstoWatchreportsin2013,2014,2015,and2019and

ledtheimprovementinimmuno-oncology

coverageontheCortellisCompetitiveIntelligenceplatform.SheholdsaPh.D.inimmunology,afirst-classBSc(Hons)degreeinpharmacology,anda

postgraduatecertificateinjournalism.

ClarivatecoverageofNSCLC

?NSCLC

DiseaseLandscape&Forecast(G7)

–Providescomprehensivemarketintelligencewithworld-class

epidemiology,keeninsightintocurrenttreatmentparadigms,anddrugforecastssupportedbydetailedprimaryandsecondary

research

?NSCLC

CurrentTreatment:PhysicianInsights:US

–Providesphysicianinsightsontreatmentdynamics,prescribingbehavior,anddriversofbranduseinNSCLC

?NSCLC

TreatmentSequencing:US

–Providessequentialtreatmentpatternsinmarket-relevant

treatmentscenariosanddrugsharemappedtotreatmentjourneyinNSCLC

?NSCLC

UnmetNeed:US/EU

–Providesinsightsintoareasofunmetneedinspecificsubpopulations

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