Efficacy

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
  • *

    Refractory disease was defined as less than a partial remission or relapse within 6 months after the last dose.

  • ||

    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) Study design for duvelisib in patients with high-risk and heavily pretreated CLL/SLL
  • 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.

≥1 preexisting condition§
Intermediate to high FLIPI score
NHL stage III/IV
Bulky disease†
Early relapse on frontline R-CHOP (or equivalent)(n=30/39)‡
≥1 preexisting condition§
Intermediate to high FLIPI score
NHL stage III/IV
Bulky disease†
Early relapse on frontline R-CHOP (or equivalent)(n=30/39)‡
  • §

    The most common conditions included hypertension (54%), fatigue (23%), and anemia (21%).5

  • †

    Baseline lesion ≥5 cm.

  • ‡

    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)†

  • †

    Patient subgroups depicted were prespecified in the DYNAMO trial.3

Study features and limitations3,10:

  • The DYNAMO trial was not powered to detect significance in patient subgroups

  • CI, confidence interval.

Patients within all analyzed subgroups had a response to COPIKTRA3

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

  • SPD, sum of the products of the perpendicular diameters.

With COPIKTRA, 47% of patients had a lymph node response, defined as a ≥50% reduction in target lymph nodes as determined by the IRC9

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COPIKTRA adverse reactions and management

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