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AZD6244

Phase 2

Melanoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Mar 14, 2016

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-BlindCONTROLLEDBiomarker
Total Trials3
Total Enrollment654
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00936221Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma PatientsPHASE2 COMPLETED 385 — — Jul 1, 2009Nov 1, 2014Mar 14, 201638 United States, Brazil +10
NCT00338130Randomised Study to Compare the Efficacy of AZD6244 vs TMZPHASE2 COMPLETED 239 — — Jul 1, 2006Jul 1, 2013Aug 13, 201433 United States, Argentina +8
NCT00710515Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 30 — — Jul 1, 2008Jun 1, 2010Aug 13, 20146 Netherlands, United Kingdom
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Study Endpoints
Primary Endpoints
Overall Survival
From date of randomization until death, withdrawal of consent or the end of the study. The end of the study was defined as the date all AZD6244 patients had been followed for a minimum of 12 months, or the date of final analysis, whichever was later

Following progression survival data was collected until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurred first.

To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)
From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)
Time to death
From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)
Objective Response Rate
RECIST data collected as per institutional standard practise
Duration of response
RECIST data collected as per institutional standard practise
To assess whether food influences the rate and extent of AZD6244 absorption
Day 1 and Day 10
Secondary Endpoints
Progression Free Survival
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Objective Response Rate
From randomization until evidence of RECIST-defined objective disease progression or data cut off, for a minimum of 12 months since start of treatment
Change in Target Lesion Tumour Size at Week 12
randomization to week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORAZD6244 in combination with dacarbazine
2PLACEBO_COMPARATORPlacebo in combination with dacarbazine
Interventions
NameTypeDescription
AZD6244DRUGoral capsules, 75mg twice daily
DacarbazineDRUG1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle
PlaceboDRUGPlacebo
TemozolomideDRUGoral
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Histological or cytological confirmation of advanced (inoperable stage III and stage IV) cutaneous or unknown primary melanoma * Tumor sample confirmed as BRAF mutation positive Exclusion Criteria: * Diagnosis of uveal or mucosal melanoma * Any prior Investigational therapy ...

Countries:United StatesBrazilCzechiaFranceGermanyHungaryNetherlandsNorwaySpainSwedenSwitzerlandUnited KingdomArgentinaAustraliaAustriaCanadaDenmark
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Competitive Landscape -Melanoma 127 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK6PHASE3Intismeran autogene, Pembrolizumab, pembrolizumab, Pembrolizumab Berahyaluronidase alfa
Bristol-Myers Squibb CompanyBMY7PHASE3Nivolumab, Nivolumab + Relatlimab, rHuPH20, Relatlimab, relatlimab+nivolumab
Regeneron Pharmaceuticals, Inc.REGN8PHASE3Fianlimab, Cemiplimab, Pembrolizumab, fianlimab, cemiplimab
Pfizer Inc.PFE4PHASE3Encorafenib, Binimetinib, Pembrolizumab, PF-08046049, PF-07799933
IDEAYA Biosciences, Inc.IDYA4PHASE3Darovasertib, IDE196, Crizotinib, Pembrolizumab, Ipilimumab
Iovance Biotherapeutics IncIOVA6PHASE3Lifileucel plus Pembrolizumab, Pembrolizumab with Optional Crossover Period, Lifileucel, LN-145/LN-144, Cyclophosphamide
Replimune Group, Inc.REPL5PHASE3Vusolimogene Oderparepvec, Nivolumab, Pembrolizumab, Single-agent chemotherapy, RP1
Amgen Inc.AMGN1PHASE3ABP 206, Nivolumab
Immunocore Holdings Plc Shs Sponsored American Depositary Shares Repr 1 ShIMCR3PHASE3Tebentafusp, Brenetafusp, Nivolumab
Immatics N.V.IMTX2PHASE3IMA203, nivolumab plus relatlimab, lifileucel, pembrolizumab, ipilimumab
Aura Biosciences IncAURA4PHASE3Bel-sar
Novartis AG Sponsored ADRNVS6PHASE2LXH254, LTT462, Trametinib, Ribociclib, DYP688
IO Biotech, Inc.IOBT2PHASE3IO102-IO103, Pembrolizumab, Pembrolizumab KEYTRUDA
Erasca, Inc.ERAS1PHASE3Naporafenib, Dacarbazine, Temozolomide, Trametinib
AstraZeneca PLCAZN3PHASE2Ceralasertib, Durvalumab, AZD6750, rilvegostomig, Trastuzumab deruxtecan
Eikon Therapeutics, Inc.EIKN2PHASE2EIK1001, Pembrolizumab, Association atezolizumab + BDB001 + RT
Moderna, Inc.MRNA1PHASE2mRNA-4157, Pembrolizumab
Genmab A/S Sponsored ADRGMAB2PHASE2Acasunlimab, Pembrolizumab, GEN1042, Cisplatin, Carboplatin
Agenus Inc.AGEN1PHASE2Botensilimab, Balstilimab
ImmunityBio IncIBRX1PHASE2N-803 + Pembrolizumab
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