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BGB-11417

Phase 2

Leukemia | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Mar 4, 2026

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 Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05479994Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaPHASE2 ACTIVE NOT_RECRUITING 100Oct 25, 2022Aug 25, 2027Mar 4, 202650 China
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Up to 2 Years

Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL)

Secondary Endpoints
Overall Response Rate (ORR) as assessed by the investigator
Up to 2 Years
Duration of response (DoR) as determined by the IRC and the investigator
Up to 5 Years
Progression Free Survival (PFS) as determined by the IRC and the investigator
Up to 5 Years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment ArmEXPERIMENTALParticipants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol
Interventions
NameTypeDescription
BGB-11417DRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites50

Key Inclusion Criteria 1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria: 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or 2. Treatment intol...

Countries:China
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Competitive Landscape -Leukemia 332 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen, HyperCVAD, Omitted Doxorubicin, Omitted Vincristine+Dexamethasone pulses
Eli Lilly and CompanyLLY10PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Venetoclax
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Rituximab, Chlorambucil, Venetoclax, Obinutuzumab
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC14PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab, Bendamustine
AbbVie, Inc.ABBV24PHASE3Venetoclax, Acalabrutinib, Obinutuzumab, Fludarabine, Cytarabine
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab, Bleximenib
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen, revumenib, cobicistat, SNDX-5613
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine, CC-486, AG-120, AG-221, BMS-986497
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine - Cytarabine - Gilteritinib, Inotuzumab ozogamicin, ALLR3, SEA-CD70, azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine, Ivosidenib, Ivosidenib + azacitidine, BN104 monotherapy
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib, Imatinib, Lisaftoclax, Acalabrutinib, Fludarabine
Actinium PharmaceuticalsATNM2PHASE3Iomab-B, Conventional Care, 131I-apamistamab, Fludarabine, Cyclophosphamide
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05479994primaryCompletionDate: changed
LOWMay 24, 2026NCT05479994studyFirstPostDate: changed