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Fruquintinib

Phase 3

NSCLC | Small molecule | Other |HUTCHMED (China) Limited|Last Updated: Nov 15, 2019

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment577
FDA Designations
PRIORITY_REVIEWBREAKTHROUGH_THERAPY
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02691299A Phase III Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung CancerPHASE3 COMPLETED 527 — — Dec 9, 2015Nov 16, 2018Feb 12, 201911 China
NCT02976116A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung CancerPHASE2 COMPLETED 50 — — Dec 1, 2016Jun 28, 2019Nov 15, 20192 China
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Study Endpoints
Primary Endpoints
overall survival (OS)
From the date of randomization until the date of death from any cause, Assessed up to 15 months

Duration from randomization to death from any cause

tumor objective response rate
Patients will be followed until study completion, an average of 1 year

Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1

Safety and tolerability
Each patient will be followed for 30 days after the last dose

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Secondary Endpoints
Objective Response Rate (ORR)
From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
progression free survival (PFS)
From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
Disease Control Rate (DCR)
From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ArmACTIVE_COMPARATORAll subjects will receive study treatment in 4-week cycles: Fruquintinib, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression.
Control ArmPLACEBO_COMPARATORAll subjects will receive study treatment in 4-week cycles: Placebo, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease
Fruquintinib & GefitinibEXPERIMENTALDrug: Fruquintinib and Gefitinib
Interventions
NameTypeDescription
FruquintinibDRUGFruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
PlaceboDRUGPlacebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
GefitinibDRUGGefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Fully understand the study and sign the informed consent form voluntarily; 2. Histologically or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC; 3. Disease progressed or developed non-tolerable toxicity after 2 lines of systemic ...

Countries:China
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