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BGB-290

Phase 2

HER2-negative Breast Cancer | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Oct 26, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03575065Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in ChinaPHASE2 COMPLETED 88 — — Jun 22, 2018Apr 14, 2021Oct 26, 202420 China
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)
From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Secondary Endpoints
ORR as Assessed by Investigator
From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)
Progression-free Survival (PFS) as Assessed by IRC and Investigator
From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)
Duration of Response (DOR) as Assessed by IRC
From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: Triple-negative breast cancer (TNBC)EXPERIMENTALLocally advanced or metastatic TNBC
Cohort 2: HR(+)/HER2(-) breast cancerEXPERIMENTALLocally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
Interventions
NameTypeDescription
BGB-290DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation 2. Locally advanced or metastatic breast cancer despite standard therapy and the following: 1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positi...

Countries:China
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