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AZD4573

Phase 2

Relapsed/Refractory Peripheral T-cell Lymphoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 28, 2024

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05140382AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHLPHASE2 COMPLETED 52Dec 15, 2021Feb 16, 2024Aug 28, 202427 United States, Australia +6
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR)
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)

Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.

Secondary Endpoints
Complete Response (CR) Rate
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Duration of Response (DoR)
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
Progression-free Survival (PFS)
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD4573 (Monotherapy)EXPERIMENTALEligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.
Interventions
NameTypeDescription
AZD4573DRUGAZD4573 will be given intravenously
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Participants who are diagnosed with one of the following, as defined by the World Health Organisation: * Peripheral T-cell Lymphoma * Classical Hodgkin Lymphoma * Eastern Cooperative Oncology Group performance status of ≤ 2. * Must have received at least 1 prior line of t...

Countries:United StatesAustraliaFranceItalySouth KoreaSwedenTaiwanUnited Kingdom
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