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Lenvatinib

Phase 2

Hepatocellular Carcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Mar 10, 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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04401800Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular CarcinomaPHASE2 COMPLETED 64 — — Sep 4, 2020Feb 18, 2024Mar 10, 20259 China
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) as Assessed by Central Imaging Facility Based on RECIST v1.1
Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months

ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation and Modification
From the date of the first dose of study drug up to 30 days after last dose of study drug (maximum time on treatment was 12 months)
Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; i.e., up to 27 months
Objective Response Rate (ORR) as Assessed by the Investigator and Central Site Imaging Facility Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Response was assessed every 6 weeks for the first year and approximately every 9 weeks thereafter through December 2022; up to 27 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Lenvatinib With TislelizumabEXPERIMENTALParticipants received lenvatinib based on baseline weight (12 milligrams \[mg\] or 8 mg once daily for participants with a baseline weight of \>= 60 kilograms \[kg\] or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first.
Interventions
NameTypeDescription
LenvatinibDRUGCapsules administered orally once daily
TislelizumabDRUG200 mg intravenous (IV) infusion administered on Day 1 of each cycle
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites9

Key Inclusion Criteria: 1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments 2. Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar...

Countries:China
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