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anvumetostat

Phase 2

MTAP-deleted NSCLC | Small molecule | Other |Amgen Inc.|Last Updated: May 28, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06593522A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)PHASE2 ACTIVE NOT_RECRUITING 61 — — Dec 26, 2024Nov 30, 2026May 28, 202691 United States, Australia +14
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Study Endpoints
Primary Endpoints
Objective Response (OR) per RECIST 1.1
Up to 35 months
Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Up to 35 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 35 months
Number of Participants Experiencing Events of Interest (EOIs)
Up to 35 months
Maximum Concentration (Cmax) of anvumetostat
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Time to Cmax (Tmax) of anvumetostat
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Area Under The Concentration-time Curve (AUC) of anvumetostat
Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Secondary Endpoints
Disease Control (DC) by BICR
Up to 35 months
Duration of Response (DOR) by BICR
Up to 35 months
Time to Response (TTR) by BICR
Up to 35 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose EvaluationEXPERIMENTALParticipants will be randomized to receive one of 2 active dose levels of anvumetostat orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).
Part 2: Dose ExpansionEXPERIMENTALParticipants will receive anvumetostat PO QD in 28-day cycles at the RP2D.
Interventions
NameTypeDescription
anvumetostatDRUGFilm-coated tablet
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites91

Inclusion Criteria: * Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC * Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for...

Countries:United StatesAustraliaBrazilCanadaChinaCzechiaHong KongJapanLatviaNetherlandsPortugalSingaporeSouth KoreaSwitzerlandTaiwanTurkey (Türkiye)
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Recent Changes (Last 90 Days)
HIGHMay 29, 2026NCT06593522Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHMay 29, 2026NCT06593522Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHMay 29, 2026NCT06593522Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 26, 2026NCT06593522primaryCompletionDate: changed
LOWMay 24, 2026NCT06593522studyFirstPostDate: changed