Recent Updates
Recently added Catalysts

MAGE-A3 ASCI

Phase 1

Bladder Cancer | Monoclonal antibody | Oncology |GSK plc|Last Updated: Feb 4, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01498172BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) PatientsPHASE1 COMPLETED 23Jan 1, 2012 -Feb 4, 20151 Switzerland
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Recording adverse events by assessment of vital signs, physical examination, haematology and blood chemistry to measure safety and tolerability
6 months
Secondary Endpoints
Flow cytometric analysis of type and number of immune cell types in urine
6 months
Measurement of titers of antibodies against recMAGE-A3 in serum
6 months
Assessment of disease recurrence by control cystoscopy
6 months
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NMIBC at intermediate risk of progressionEXPERIMENTAL -
NMIBC at high risk of progressionEXPERIMENTAL -
NMIBC at low risk of progressionEXPERIMENTAL -
Interventions
NameTypeDescription
MAGE-A3 ASCIBIOLOGICAL5 doses every 3 weeks
BCGBIOLOGICAL1 intravesical dose /week for 6 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patient with histological confirmation of NMIBC * Full recovery from surgery (TUR) from 1 to 6 weeks * Karnofsky performance status of 60% or more * Laboratory parameters for vital functions should be in the normal range * Women of childbearing potential must us...

Countries:Switzerland
Unlock Eligibility Criteria
Competitive Landscape -Bladder Cancer 147 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN15PHASE3Durvalumab, Bacillus Calmette-Guerin, Tremelimumab, Enfortumab Vedotin, Cisplatin
Bristol-Myers Squibb CompanyBMY5PHASE3Nivolumab, Gemcitabine, Cisplatin, Ipilimumab, Carboplatin
Johnson & JohnsonJNJ13PHASE3TAR-200, Mitomycin C, Gemcitabine, Cetrelimab, BCG Vesiculture
Merck & Co., Inc.MRK13PHASE3Pembrolizumab, BCG, Cisplatin, Fluorouracil, Mitomycin C
Pfizer Inc.PFE10PHASE3PF-06801591, Bacillus Calmette-Guerin, Avelumab, Lorlatanib, Talazoparib
Eli Lilly and CompanyLLY4PHASE3Vepugratinib, EV, Pembrolizumab, LY4101174, LY4052031
UroGen Pharma Ltd.URGN4PHASE3UGN-103, UGN-102, UGN-104, Jelmyto for pyelocalyceal
Natera, Inc.NTRA2PHASE3Atezolizumab
CG Oncology, Inc.CGON2PHASE3Cretostimogene Grenadenorepvec
Protara Therapeutics, Inc.TARA2PHASE3TARA-002
Relmada Therapeutics IncRLMD2PHASE3NDV-01, NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
ImmunityBio IncIBRX6PHASE2N-803 and BCG, N-803 + Pembrolizumab, BCG + N-803, Intravesical Recombinant Mycobacterium, N803 plus Bacillus Calmette-Guerin
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Tislelizumab, Cisplatin, Gemcitabine, Carboplatin, BGB-A445
Exelixis, Inc.EXEL4PHASE2Cabozantinib, Atezolizumab, Zanzalintinib, cabozantinib, atezolizumab
Gilead Sciences, Inc.GILD2PHASE2Sacituzumab Govitecan-hziy, Pembrolizumab, Cisplatin, Avelumab, Zimberelimab
Tyra Bioscience, IncTYRA3PHASE2Dabogratinib, Dabogratinib TBD, TYRA-300, TYRA-300 Dose TBD
BioNTech SE Sponsored ADRBNTX1PHASE2Autogene Cevumeran, Nivolumab, Saline
ICON PlcICLR1PHASE3padeliporfin VTP
AbbVie, Inc.ABBV1PHASE2Livmoniplimab, Budigalimab, Docetaxel, Paclitaxel, Gemcitabine
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
Unlock Competitive Intelligence