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Pirtobrutinib

Phase 2

Mantle Cell Lymphoma | Small molecule | Oncology |AbbVie Inc.|Last Updated: Apr 16, 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 Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06522386GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell LymphomaPHASE2 ACTIVE NOT_RECRUITING 50 — — Jan 30, 2025Feb 28, 2029Apr 16, 20262 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pirtobrutinib, Rituximab and Venetoclax combinationEXPERIMENTAL -
Interventions
NameTypeDescription
PirtobrutinibDRUGGiven by mouth
RituximabDRUGGiven by vein (IV)
VenetoclaxDRUGGiven by mouth
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression (e.g., positive immunohistochemistry staining). 3. MCL cells are CD20 positive (e.g., positive staining on immunohistochemistry or flow cytometry)....

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06522386Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06522386studyFirstPostDate: changed