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Pumitamig

Phase 3

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 3, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,600
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07361497A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)PHASE3 RECRUITING 850Mar 16, 2026Dec 31, 2033Jun 3, 2026255 United States, Argentina +30
NCT07361510A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)PHASE3 RECRUITING 750Mar 12, 2026Oct 14, 2031Jun 3, 2026273 United States, Argentina +34
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Up to 3 years
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 3 years
Overall survival (OS)
Up to approximately 5 years
Secondary Endpoints
Overall survival (OS)
Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Up to 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm A: PumitamigEXPERIMENTAL -
Arm B: PembrolizumabACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PumitamigDRUGSpecified dose on specified days
DurvalumabDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites255

Inclusion Criteria * Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. * Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaFranceGermanyGreeceHong KongHungaryIndiaIrelandItalyJapanMexicoNetherlandsPolandRomaniaSingaporeSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United KingdomColombiaCzechiaFinlandMalaysiaNorwayPeruPortugal
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361510lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361510lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361510lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361510lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 4, 2026NCT07361510lastUpdatePostDate: changed
LOWMay 26, 2026NCT07361497Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07361510Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07361497studyFirstPostDate: changed
LOWMay 24, 2026NCT07361510studyFirstPostDate: changed