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zalutumumab

Phase 3

Head and Neck Cancer | Monoclonal antibody | Oncology |Genmab A/S|Last Updated: Aug 2, 2023

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
UNCONTROLLED
Total Trials3
Total Enrollment407
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00382031Zalutumumab in Patients With Non-curable Head and Neck CancerPHASE3 COMPLETED 286 — — Nov 1, 2006Aug 1, 2011Oct 14, 2013 - —
NCT00542308Zalutumumab in Non-curable Patients With SCCHNPHASE2 COMPLETED 90 — — Jan 1, 2008Aug 1, 2011Aug 2, 2023 - —
NCT01054625Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)PHASE1/PHASE2 COMPLETED 31 — — Mar 1, 2010Oct 1, 2011Aug 2, 2023 - —
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Study Design & Arms
Interventions
NameTypeDescription
ZalutumumabDRUGIndividual dose titration weekly i.v doses
ControlOTHERBest Supportive Care
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Competitive Landscape -Head and Neck Cancer 156 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN9PHASE3Monalizumab, Cetuximab, volrustomig, Volrustomig, Cisplatin
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Remzistotug, Niraparib
Merck & Co., Inc.MRK3PHASE3Pembrolizumab, Cisplatin /m^2, pembrolizumab, Cisplatin, Docetaxel
Johnson & JohnsonJNJ4PHASE3JNJ-90301900, Cetuximab, Amivantamab, Pembrolizumab, Carboplatin
Pfizer Inc.PFE6PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, Palbociclib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2cemiplimab, Platinum Doublet, fianlimab, fianlimab+cemiplimab, Cemiplimab
PDS Biotechnology Corp.PDSB1PHASE3Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
Exelixis, Inc.EXEL4PHASE2Zanzalintinib, Pembrolizumab, cabozantinib, atezolizumab, Nivolumab
Merus B.V.MRUS4PHASE3Petosemtamab, Pembrolizumab, MCLA-129, Osimertinib, Chemotherapy
Bristol-Myers Squibb CompanyBMY3PHASE2Nivolumab, Relatlimab, Ipilimumab, Intratumoral Ipilimumab, BMS-986340
Bicara Therapeutics Inc.BCAX3PHASE2Ficerafusp alfa, Nivolumab, Pembrolizumab, BCA101
Gilead Sciences, Inc.GILD2PHASE2Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
Inhibrx Biosciences, Inc.INBX2PHASE2INBRX-106, Pembrolizumab, INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5
Incyte CorporationINCY1PHASE2Retifanlimab, INCAGN02385, INCAGN02390
BioNTech SE Sponsored ADRBNTX1PHASE2BNT113, Pembrolizumab
Coherus Oncology, Inc.CHRS4PHASE2Toripalimab, Carboplatin, Cisplatin, Paclitaxel, Docetaxel
ALX Oncology Holdings, Inc.ALXO3PHASE2evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU, ALX2004
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, PD-L1 t-haNK, Cetuximab, NAI
Summit Therapeutics IncSMMT2PHASE3Ivonescimab /kg, Ligufalimab, Pembrolizumab, Ivonescimab
IO Biotech, Inc.IOBT1PHASE2IO102-IO103, Pembrolizumab KEYTRUDA
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