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Pumitamig

Phase 3

Extensive-stage Small-cell Lung Cancer | Small molecule | Oncology |BioNTech SE|Last Updated: Jun 1, 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 Trials1
Total Enrollment621
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06712355Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung CancerPHASE3 RECRUITING 621Feb 3, 2025Mar 1, 2029Jun 1, 2026202 United States, Australia +11
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Study Endpoints
Primary Endpoints
Overall survival (OS)
Up to approximately 46 months

OS defined as the time from randomization to death from any cause.

Secondary Endpoints
Progression-free survival (PFS)
Up to approximately 46 months
Objective response rate (ORR)
Up to approximately 46 months
Duration of response (DOR)
Up to approximately 46 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1 Control Arm - Atezolizumab + Etoposide + CarboplatinACTIVE_COMPARATOR -
Stage 1 Treatment Arm 1 - Pumitamig Dose 1 + Etoposide + CarboplatinEXPERIMENTAL -
Stage 1 Treatment Arm 2 - Pumitamig Dose 2 + Etoposide + CarboplatinEXPERIMENTAL -
Stage 2 Control Arm - Atezolizumab + Etoposide + CarboplatinACTIVE_COMPARATOR -
Stage 2 Treatment Arm - Pumitamig Dose 3 + Etoposide + CarboplatinEXPERIMENTAL -
Interventions
NameTypeDescription
PumitamigDRUGIntravenous infusion
AtezolizumabDRUGIntravenous infusion
EtoposideDRUGIntravenous infusion and capsules
Carboplatin (or cisplatin if carboplatin is not tolerated)DRUGIntravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites202

Inclusion Criteria: * Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis...

Countries:United StatesAustraliaChinaFranceGermanyItalyJapanPolandRomaniaSouth KoreaSpainTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06712355lastUpdatePostDate: changed
LOWJun 2, 2026NCT06712355lastUpdatePostDate: changed
LOWJun 2, 2026NCT06712355lastUpdatePostDate: changed
LOWMay 26, 2026NCT06712355primaryCompletionDate: changed
LOWMay 24, 2026NCT06712355studyFirstPostDate: changed