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Obinutuzumab and Pixantrone

Phase 2

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: Mar 31, 2022

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02499003GOAL: GA101 Plus Pixantrone for Relapsed Aggressive LymphomaPHASE2 COMPLETED 70Aug 14, 2015Jan 2, 2022Mar 31, 20221 Germany
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Study Endpoints
Primary Endpoints
Objective overall response rate (ORR) after six treatment cycles or the individual end of treatment
30 weeks

The response to treatment is measured by results of computer tomography (CT) for measurable lesions and evaluation for non-measurable lesions after cycle 6 or at the individual end of treatment.

Secondary Endpoints
Safety of the combination treatment as measured by the rate of adverse events, which reflects tolerability of the treatment.
30 weeks
Percentage of patients completing the entire trial treatment
30 weeks
Evaluation of best response to trial treatment as measured as best response either during or post the entire treatment
30 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Obinutuzumab and PixantroneEXPERIMENTALObinutuzumab: 1000 mg flat dose on day 1, 8, 15 of cycle one and day 1 of subsequent cycles Pixantrone: 50 mg/m² Pixantrone on day 1,8,15 of each 28 d cycle
Interventions
NameTypeDescription
Obinutuzumab and PixantroneDRUGObinutuzumab: 1000 mg flat dose on day 1, 8, 15 of cycle one and day 1 of subsequent cycles, Pixantrone: 50 mg/m² Pixantrone on day 1,8,15 of each 28 d cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients aged ≥ 18 years * Histologically proven diagnosis of diffuse large cell B-cell lymphoma (DLBCL), follicular lymphoma (FL) IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review) * Relapsed disease * Ea...

Countries:Germany
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