Patients with heavily pretreated FL responded to single-agent COPIKTRA
COPIKTRA (duvelisib) was evaluated in DYNAMO, a pivotal phase 2 trial for patients with heavily pretreated FL5
DYNAMO was a single-arm, open-label, multicenter trial that met its primary endpoint of ORR in patients with measurable iNHL who were refractory* to rituximab (monotherapy or in combination) and to either chemotherapy or radioimmunotherapy10
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COPIKTRA was administered at 25 mg BID in 28-day treatment cycles until disease progression or unacceptable toxicity.5
BID, twice a day; ECOG, Eastern Cooperative Oncology Group; FDA, US Food and Drug Administration; iNHL, indolent non-Hodgkin lymphoma; IRC, independent review committee; MZL, marginal zone B-cell lymphoma; SLL, small lymphocytic lymphoma.
- Efficacy was based on ORR and DOR, as assessed by the IRC (n=83)
- Safety was based on 4 clinical trials totaling 442 patients with previously treated hematologic malignancies who received COPIKTRA 25 mg BID
- COPIKTRA is not approved in MZL
Key baseline characteristics (n=83)5:
- Median age of 64 years (range: 30-82 years)
- ECOG performance status of 0-2
Primary endpoint5,10:
- Overall response rate (ORR) (IRC assessed)
Other efficacy measures5,10:
- Duration of response (DOR)
- Progression-free survival (PFS)
- Time to response (TTR)
COPIKTRA™ (duvelisib) may be appropriate for high-risk patients
Patients with FL in DYNAMO were heavily pretreated and recently relapsed (n=83)
- Patients received a median of 3 prior anticancer regimens (range, 1-10)
- Median time since completion of last therapy was 3.2 months before treatment with COPIKTRA5
- Prior types of therapy included bendamustine (65%), R-CHOP (46%), R-CVP (28%), and radioimmunotherapy (7%)5
DYNAMO included FL patients with high-risk clinical characteristics at baseline (n=83)5,10
Select a patient characteristic below to reveal the subpopulation.





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The most common conditions included hypertension (54%), fatigue (23%), and anemia (21%).5
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Baseline lesion ≥5 cm.
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Early relapse was defined as no response during treatment; progressive disease in less than 2 years; or time to next treatment in less than 2 years.10
R-CHOP, rituximab-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone; R-CVP, rituximab-cyclophosphamide, vincristine sulfate, prednisone.
COPIKTRA may be appropriate for FL patients with high tumor burden and certain preexisting conditions5
Meaningful clinical activity
*Data were evaluated per the IRC according to Revised International Working Group criteria.
- 1 patient achieved a complete response; 34 patients achieved partial responses
- Median duration of response was 10 months (95% CI: 4.5-21.9)7
- 17% of patients (n=6/35) maintained response as 12 months
- Median time to first response was 1.91 months (range, 1.6-11.7 months) with COPIKTRA6
43% of patients (n=15/35) maintained a response at 6 months with COPIKTRA1
ORR subgroup analysis
ORR analysis was conducted for COPIKTRA across patient subgroups (n=83)†
Study features and limitations3,10:
- The DYNAMO trial was not powered to detect significance in patient subgroups
Additional data
Progression-free survival5,10
Study features and limitations:
- PFS was a prespecified secondary endpoint in the DYNAMO trial
- The DYNAMO trial was a single-arm study and not powered to detect significance of PFS
- Median duration of response was 10 months (95% CI: 4.5-21.9)7
- 17% of patients (n=6/35) maintained a response at 12 months
In the DYNAMO trial, patients with FL had a median treatment duration of 5 months (range, 0.4-24 months) on COPIKTRA
Lymph node responses9
Study features and limitations:
- Results are from a prespecified, exploratory analysis of patients with measurable lymph node response rates (n=75/83)
- The DYNAMO trial was a single-arm study and not powered to detect significance of lymph node responses