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DYNAMO

DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma

Phase 2N = 129NCT01882803

Population
Indolent non-Hodgkin lymphoma double refractory to rituximab and to chemotherapy or radioimmunotherapy; median age 65 years, median 3 prior lines.
Design
Open-label, global phase II trial of duvelisib 25 mg orally twice daily in 28-day cycles until progression, unacceptable toxicity or death, in 129 patients with measurable indolent non-Hodgkin lymphoma (follicular, small lymphocytic or marginal zone lymphoma) double refractory to rituximab and to either chemotherapy or radioimmunotherapy. Primary endpoint: overall response rate by revised International Working Group criteria.
Primary endpoint
ORR
Arms
  • Duvelisib (experimental, n = 129): Duvelisib 25 mg orally twice daily in 28-day cycles
People
Flinn IW
Show the numbers
Results reported for DYNAMO
EndpointAnalysisDuvelisibControlEffect
ORRAll 129 enrolled patientsprimaryFlinn 201947.3%—By subtype: small lymphocytic lymphoma 67.9%, follicular lymphoma 42.2%, marginal zone lymphoma 38.9%.
ORRFollicular lymphoma subgroup (subgroup size not given in the abstract)primaryFlinn 201942.2%——
PFSAll 129 enrolled patientsprimaryFlinn 2019median 9.5 months—Estimated median; estimated median duration of response was 10 months. Secondary endpoint.
Results reported for DYNAMO
EndpointAnalysisDuvelisibControlEffect
ORRAll 129 enrolled patientsprimaryFlinn 201947.3%—By subtype: small lymphocytic lymphoma 67.9%, follicular lymphoma 42.2%, marginal zone lymphoma 38.9%.
ORRFollicular lymphoma subgroup (subgroup size not given in the abstract)primaryFlinn 201942.2%——
PFSAll 129 enrolled patientsprimaryFlinn 2019median 9.5 months—Estimated median; estimated median duration of response was 10 months. Secondary endpoint.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Duvelisib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDuvelisib
0100.0%
664.5%
1241.7%
1826.9%
2417.4%
Primary publication: Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019;37(11):912-922. PubMedDOI

Appears in

Sources

  1. Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, et al. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019;37(11):912-922.

    PubMedDOI