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duvelisib

Phase 1

Lymphoma | Small molecule | Oncology |AbbVie Inc.|Last Updated: Feb 6, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02598570Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory LymphomaPHASE1 COMPLETED 7 — — Nov 1, 2015Feb 1, 2017Feb 6, 20173 Japan
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Study Endpoints
Primary Endpoints
Number of participants reporting Treatment-emergent Adverse Events
Throughout the study for approximately 2 years

The number of participants reporting treatment-emergent adverse events.

Maximum Observed Plasma Concentration (Cmax) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Time to Maximum Observed Concentration (Tmax) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib
Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
Secondary Endpoints
Overall Response Rate
Throughout the study for approximately 2 years
Overall Survival
Throughout the study for approximately 2 years
Progression Free Survival
Throughout the study for approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
duvelisibEXPERIMENTALDuvelisib will be administered orally as a fixed dose in 28-day cycles.
Interventions
NameTypeDescription
duvelisibDRUGDuvelisib will be administered orally as a fixed dose in 28-day cycles.
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Eligibility Criteria
Age Range20 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosis of lymphoma (excluding lymphoblastic lymphoma) * Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy * Eastern Cooperative Oncology Group (ECOG) performance status lower th...

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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