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plerixafor GZ316455

Phase 2

Lymphoma | Small molecule | Oncology |Sanofi|Last Updated: Mar 30, 2016

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02221492Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin LymphomaPHASE2 COMPLETED 32 — — Nov 1, 2014Mar 1, 2016Mar 30, 201612 Japan
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Study Endpoints
Primary Endpoints
Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Secondary Endpoints
Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells
Day 5 to Day 8 of the apheresis/treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
granulocyte colony-stimulating factor aloneACTIVE_COMPARATORG-CSF administered up to 8 days
granulocyte colony-stimulating factor plus plerixaforEXPERIMENTALG-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
Interventions
NameTypeDescription
plerixafor GZ316455DRUGPharmaceutical form:vial Route of administration: subcutaneous injection
FilgrastimDRUGPharmaceutical form:vial Route of administration: subcutaneous injection
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Eligibility Criteria
Age Range20 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion criteria: * Age 20 to 75. * Japanese participants with histological or pathological diagnosis of NHL. * First or second complete response (CR) or partial response (PR). Exclusion criteria: * Leukemia participants. * Myelodysplastic syndrome (MDS) participants. * Less than 2 weeks since ...

Countries:Japan
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Competitive Landscape -Lymphoma 345 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN7PHASE3Odronextamab, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Eli Lilly and CompanyLLY13PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Ibrutinib
Merck & Co., Inc.MRK16PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
AstraZeneca PLCAZN15PHASE3Surovatamig, R-CHOP, R-CVP, BR, AZD0486
Novartis AG Sponsored ADRNVS8PHASE3Tisagenlecleucel, Lenalidomide and rituximab in 28-day cycles for up to 12 cycles., Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone in 21-day cycles for 6 to 8 cycles, Lymphodepleting chemotherapy, CTL019
Incyte CorporationINCY16PHASE3Tafasitamab, Lenalidomide, tafasitamab, rituximab, lenalidomide
BeOne Medicines Ltd. Sponsored ADRONC21PHASE3Zanubrutinib, Bendamustine, Rituximab, Venetoclax, Tislelizumab
Gilead Sciences, Inc.GILD7PHASE3Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
AbbVie, Inc.ABBV11PHASE3Venetoclax, Loncastuximab Tesirine and Epcoritamab, Venetoclax; Rituximab, DRC, Obinutuzumab
Genmab A/S Sponsored ADRGMAB18PHASE3Epcoritamab, Rituximab, Lenalidomide, Oxaliplatin, Gemcitabine
Bristol-Myers Squibb CompanyBMY18PHASE3Azacitidine, Romidepsin, Gemcitabine, Golcadomide, Rituximab
Johnson & JohnsonJNJ11PHASE3Ibrutinib, Ibrutinib / Bortezomib / Rituximab, Venetoclax, JNJ-90009530, JNJ-80948543
Pfizer Inc.PFE4PHASE3Brentuximab vedotin, Rituximab, Lenalidomide, Gemcitabine, Dexamethasone
Nurix Therapeutics, Inc.NRIX6PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
ADC Therapeutics LtdADCT4PHASE3Loncastuximab Tesirine, Rituximab, Gemcitabine, Oxaliplatin, Cyclophosphamide
Corvus Pharmaceuticals, Inc.CRVS2PHASE3Soquelitinib, Belinostat, Pralatrexate, CPI-818
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
HUTCHMED (China) Limited Sponsored ADRHCM2PHASE3HMPL-760, R-GemOx, HMPL-760 planned dose 1
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib, Alectinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK8PHASE2Brentuximab Vedotin, Cyclophosphamide, Doxorubicin, Prednisone, TAK-007
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