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HMPL-689

Phase 2

Marginal Zone Lymphoma | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Apr 6, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment178
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04849351Clinical Study of HMPL-689 for Relapsed/Refractory Marginal Zone Lymphoma and Follicular LymphomaPHASE2 COMPLETED 178 — — Apr 15, 2021Feb 29, 2024Apr 6, 202558 China
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Study Endpoints
Primary Endpoints
Overall response rate (ORR)
Baseline up to the last patient has completed 12 months after treatment.

Defined as the proportion of patients with CR or PR

Secondary Endpoints
Complete response (CR) rate
Baseline up to the last patient has completed 12 months after treatment.
Progression-free survival (PFS)
Baseline up to the last patient has completed 12 months after treatment.
Time to response (TTR)
Baseline up to the last patient has completed 12 months after treatment.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Relapsed/Refractory MZL and FLEXPERIMENTALRelapsed/Refractory Marginal Zone Lymphoma and Follicular Lymphoma
Interventions
NameTypeDescription
HMPL-689DRUGAll patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: 1. Age ≥18 years; 2. Patients with relapsed/refractory marginal zone lymphoma or follicular lymphoma 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-2; 4. At least one measurable lesion by computerised tomography (CT) / magnetic resonance imaging (MRI) (t...

Countries:China
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