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MEDI4736 monotherapy

Phase 2

Metastatic Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 2, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment65
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02558894Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal CarcinomaPHASE2 COMPLETED 65 — — Nov 16, 2015Jun 15, 2017Aug 2, 201821 United States, Canada +4
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).

Secondary Endpoints
Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1
From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
PFS Rate at 3 Months and at 6 Months
From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)
Overall Survival (OS)
From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEDI4736 monotherapyEXPERIMENTALMEDI4736 via IV infusion.
tremelimumab+MEDI4736EXPERIMENTALMEDI4736+tremelimumab via IV infusion.
Interventions
NameTypeDescription
MEDI4736 monotherapyDRUGMEDI4736 via IV infusion.
tremelimumab+MEDI4736DRUGtremelimumab+MEDI4736 via IV infusion.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: - 1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen 2. Eastern Cooperative Oncology Group 0 or 1 3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (...

Countries:United StatesCanadaGermanyNetherlandsSouth KoreaSpain
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