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Rituxan

Phase 2

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Dynavax Technologies Corporation|Last Updated: Jan 29, 2010

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00251394Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular LymphomaPHASE2 COMPLETED 30 — — Jul 1, 2004Jul 1, 2009Jan 29, 20103 United States
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Study Endpoints
Primary Endpoints
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
2 years
Secondary Endpoints
To assess the overall response rate following treatment
2 years
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
RituxanDRUGGiven intravenously once weekly for four weeks.
1018 ISSDRUGGiven as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 18 years of age or older * Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma * Received at least one previous chemotherapy regimen for lymphoma * Hemoglobin \> 8.5 g/dl * WBC \> 2,000/mm3 * ANC \> 1,000/mm3 * Platelet count \> 75,000/mm3 * ECOG performan...

Countries:United States
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