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Ramucirumab

Phase 3

Breast Cancer | Monoclonal antibody | Oncology |Eli Lilly and Company|Last Updated: Dec 6, 2021

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,292
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00703326Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast CancerPHASE3 COMPLETED 1,144Aug 6, 2008Nov 19, 2020Dec 6, 2021232 United States, Australia +21
NCT01427933A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast CancerPHASE2 COMPLETED 141Nov 1, 2011Jun 1, 2014Feb 6, 201752 United States
NCT01256567A Study of Ramucirumab (IMC-1121B) in Participants With Breast CancerPHASE1 COMPLETED 7Dec 1, 2010Feb 1, 2013Jun 18, 20144 Japan
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS)
Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)

PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progressed nor died were censored the day of their last radiographic tumor assessment if available or date of randomization if no post initiation radiographic assessment was available. If death or PD occurred after ≥2 missing radiographic visits, censoring occurred at date of the last radiographic visit prior to the missed visits. The symptomatic/clinical disease progression (deterioration) without documented radiologic progression did not constitute progression.

Number of Participants With Adverse Events
Baseline up to data cut off (approximately 48.3 weeks)

Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia \>7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc \>500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay \>2 weeks due to toxicity.

Secondary Endpoints
Overall Survival (OS)
Randomization to death or until data cutoff of 29-May-2015 (up to 82 months)
Time to Progression (TTP)
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ramucirumab (IMC-1121B) + docetaxelEXPERIMENTAL -
placebo + docetaxelPLACEBO_COMPARATOR -
Ramucirumab and EribulinEXPERIMENTALRamucirumab 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Eribulin MonotherapyACTIVE_COMPARATOREribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
ramucirumab and docetaxel combinationEXPERIMENTAL -
Interventions
NameTypeDescription
ramucirumab (IMC-1121B)BIOLOGICALRamucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
docetaxelDRUGDocetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
PlaceboOTHERPlacebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
EribulinDRUGAdministered intravenously
RamucirumabBIOLOGICALRamucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites232

Inclusion Criteria: * Participant is able to provide signed informed consent * Participant is female and ≥ 18 years of age or older if required by local laws or regulations * Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-rec...

Countries:United StatesAustraliaBelgiumBrazilCanadaCroatiaCzechiaEgyptGermanyIrelandIsraelLebanonNew ZealandPeruPolandRussiaSerbiaSlovakiaSouth AfricaSouth KoreaSpainTaiwanUnited KingdomJapan
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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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