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Petosemtamab + Pembrolizumab

Phase 2

Lung Cancer - Non Small Cell Squamous | Monoclonal antibody | Oncology |Merus N.V.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07353957Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung CancerPHASE2 RECRUITING 180Mar 27, 2025Feb 27, 2031Jun 5, 202624 United States, Australia +5
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Study Endpoints
Primary Endpoints
Objective response rate per investigator assessment
Up to 4.5 years

ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) per RECIST v1.1.

Secondary Endpoints
Duration of response per Investigator assessment
Up to 4.5 years
Disease control rate as per investigator assessment
Up to 4.5 years
Clinical Benefit Rate as per investigator assessment
Up to 4.5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
First line squamous non-small cell lung cancer patientsEXPERIMENTAL -
First line non-squamous non-small cell lung cancer patientsEXPERIMENTAL -
Interventions
NameTypeDescription
Petosemtamab + PembrolizumabCOMBINATION_PRODUCTPetosemtamab + Pembrolizumab
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements * Age ≥ 18 years at the signing of ICF * At least 1 measurable lesion as defined by RECIST 1.1 * ECOG performance status of 0 or 1 * Life expecta...

Countries:United StatesAustraliaFranceItalyNetherlandsSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07353957lastUpdatePostDate: changed
LOWJun 5, 2026NCT07353957lastUpdatePostDate: changed
LOWJun 5, 2026NCT07353957lastUpdatePostDate: changed
LOWJun 5, 2026NCT07353957lastUpdatePostDate: changed
LOWMay 27, 2026NCT07353957lastUpdatePostDate: changed
LOWMay 27, 2026NCT07353957lastUpdatePostDate: changed
LOWMay 26, 2026NCT07353957primaryCompletionDate: changed
LOWMay 24, 2026NCT07353957studyFirstPostDate: changed