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vepdegestrant

Phase 3

Breast Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 6, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment141
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05909397Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast CancerPHASE3 ACTIVE NOT_RECRUITING 59 — — Aug 9, 2023Dec 30, 2026Feb 10, 202629 United States, Australia +8
NCT06206837A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.PHASE1 ACTIVE NOT_RECRUITING 71 — — Feb 19, 2024Sep 7, 2026Feb 27, 202658 United States, Belgium +6
NCT06125522TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C)PHASE1 ACTIVE NOT_RECRUITING 11 — — Jan 10, 2024Dec 31, 2026May 6, 202621 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Study Lead-in (SLI): Incidence of Grade 4 neutropenia
From randomization date up to Cycle 4 (each cycle is 28 days).

It is defined as the number of participants with Grade 4 neutropenia AE (graded by NCI CTCAE v.5.0) with onset within the first 4 cycles divided by the number of participants.

SLI: Incidence of dose reduction
From randomization date up to Cycle 4 (each cycle is 28 days).

It is defined as the number of participants reducing the dose of palbociclib and/or vepdegestrant due to any cause occurring within the first 4 cycles divided by the number of participants.

SLI: Incidence of drug discontinuation.
From randomization date up to Cycle 4 (each cycle is 28 days).

It is defined as the number of participants discontinuing palbociclib and/or vepdegestrant due to any cause occurring within the first 4 cycles divided by the number of participants.

Phase 3: Progression-Free Survival
From randomization date, every 12 weeks, to date of first documentation of progression or death, up to approximately 4 years.

Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) or death due to any cause, whichever come first.

Phase 1b: Number of Participants With Dose Limiting Toxicities
28 days

Dose Limiting Toxicities (DLTs) rate for Vepdegestrant in combination with PF-07220060, estimated based on data from DLT-evaluable participants during the DLT observation period (Cycle 1).

Phase 2: Percentage of Participants With Objective Response by investigator assessment
Up to approximately 1 year

Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. as determined by investigator assessment.

Drug Drug Interaction: To evaluate the effect of samuraciclib on PK of ARV 471.
From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days)

Steady-state Area under the plasma concentration versus time curve (AUCtau) of ARV-471 with and without coadministration of samuraciclib

Drug Drug Interaction: • To evaluate the effect of ARV 471 on PK of samuraciclib.
From the start of Lead-in period (maximum 13 days) to the end of cycle 1 (at least 28 days))

Single dose AUC0-72 of samuraciclib with and without coadministration of ARV 471.

Secondary Endpoints
SLI and Phase 3. Objective Response Rate
From randomization date, every 12 weeks, to the date of progression or death (up to approximately 4 years).
SLI and Phase 3: Duration of Response
From the date of the first objective response, every 12 weeks, to the date of disease progression or death (up to approximately 4 years).
SLI and Phase 3: Clinical Benefit Rate
Every 12 weeks From randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A (Investigational Arm)EXPERIMENTALParticipants will receive: * Vepdegestrant, orally, once daily, continuously, in a 28-day cycle, plus * Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment in a 28 day cycle
Arm B (Comparator Arm):ACTIVE_COMPARATORParticipants will receive: * Letrozole, orally, once daily, continuously, in a 28-day cycle, plus * Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle.
vepdegestrant in combination with PF-07220060EXPERIMENTALvepdegestrant administered orally once daily (QD) continuously and PF-07220060 administered orally twice daily (BID) continuously on 28-day cycles
ARV-471 in combination with SamuraciclibEXPERIMENTALARV-471 administered orally QD continuously and Samuraciclib administered orally QD continuously on 28-day cycles
Interventions
NameTypeDescription
Vepdegestrant (ARV-471/PF-07850327)DRUGPharmaceutical form: Tablets. Route of Administration: Oral
PalbociclibCOMBINATION_PRODUCTPharmaceutical form: Capsules. Route of Administration: Oral.
LetrozoleDRUGPharmaceutical form: Capsules. Route of Administration: Orally
vepdegestrantDRUGDaily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
PF-07220060DRUGDaily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
SamuraciclibDRUGDaily oral dosages of Samuraciclib continuously, dose escalation/de-escalation in Phase 1b until RP2D determined, cycles lasting 28 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment * Confirmed diagnosis of ER+/HER2- breast cancer * No prior systemic treatment for loco-regional recurrent or metastatic disease * Measurable disease evaluable per Response...

Countries:United StatesAustraliaBrazilChinaHungaryItalyJapanSlovakiaSpainSwitzerlandBelgiumCanadaFrancePuerto Rico
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Competitive Landscape -Breast Cancer 408 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib, Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy, Imlunestrant, Tamoxifen, Anastrozole
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1, Capecitabine, Paclitaxel, Nab-paclitaxel
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Fulvestrant, Trastuzumab, Pertuzumab
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant, PF-07220060, letrozole, abemaciclib
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib, Arm A: Gedatolisib + Palbociclib + Fulvestrant
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant, Palbociclib, Ribociclib
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam, Alisertib, Endocrine therapy
Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05909397primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06125522primaryCompletionDate: changed
LOWMay 26, 2026NCT06206837primaryCompletionDate: changed
LOWMay 24, 2026NCT05909397studyFirstPostDate: changed
LOWMay 24, 2026NCT06125522studyFirstPostDate: changed
LOWMay 24, 2026NCT06206837studyFirstPostDate: changed