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Margetuximab

Phase 3

HER-2 Positive Breast Cancer | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: Mar 17, 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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment624
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02492711Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast CancerPHASE3 COMPLETED 624 — — Aug 24, 2015Jun 14, 2022Mar 17, 2025167 United States, Austria +16
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Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) as Determined by Independent Radiological Review.
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.

PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.

Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).
Throughout the study, average 21 months

Overall survival is the time from randomization until death from any cause

Number of Patients With Grade 3 or Higher Infusion Related Reactions
22 days

Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment

Secondary Endpoints
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review.
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Infusion Rate Sub-study All Safety
Throughout the study, average duration 6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Margetuximab plus chemotherapyEXPERIMENTALMargetuximab 15 mg/kg every 21 days
Trastuzumab plus chemotherapyACTIVE_COMPARATORTrastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days
Margetuximab Infusion Sub-studyEXPERIMENTALMargetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.
Interventions
NameTypeDescription
MargetuximabBIOLOGICAL15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
TrastuzumabBIOLOGICAL8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion on day 1 of each 21 day cycle
Physician's choice of chemotherapy.DRUGCapecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites167

Inclusion Criteria: * Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative. * Have received at ...

Countries:United StatesAustriaBelgiumCanadaCzechiaDenmarkFinlandFranceGermanyIsraelItalyNetherlandsPolandPortugalPuerto RicoSouth KoreaSpainUnited Kingdom
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