Skip to content
Bending the Curve Trial by Trial
?

DELTA

PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma

Phase 2N = 125NCT01282424

Population
Indolent non-Hodgkin lymphoma with no response to rituximab and an alkylating agent, or relapse within 6 months of those therapies; 72 of 125 had follicular lymphoma. Median 4 prior therapies.
Design
Single-group, open-label phase 2 study of idelalisib 150 mg twice daily until progression or withdrawal in 125 patients with indolent non-Hodgkin lymphoma who had not responded to rituximab and an alkylating agent, or had relapsed within 6 months of those therapies. Primary endpoint: overall response rate. Subtypes: follicular lymphoma (72 patients), small lymphocytic lymphoma (28), marginal-zone lymphoma (15) and lymphoplasmacytic lymphoma (10).
Primary endpoint
ORR
Arms
  • Idelalisib (experimental, n = 125): Idelalisib 150 mg twice daily until progression or withdrawal
People
Gopal AK
Show the numbers
Results reported for DELTA
EndpointAnalysisIdelalisibControlEffect
ORRAll 125 patients (indolent non-Hodgkin lymphoma subtypes combined)primaryGopal 201457%—71 of 125 patients responded; 6% met criteria for a complete response. The abstract gives no follicular-lymphoma-specific response rate, only that response rates were similar across subtypes.
PFSAll 125 patients (indolent non-Hodgkin lymphoma subtypes combined)primaryGopal 2014median 11 months—Median duration of response was 12.5 months. Secondary endpoint.
Results reported for DELTA
EndpointAnalysisIdelalisibControlEffect
ORRAll 125 patients (indolent non-Hodgkin lymphoma subtypes combined)primaryGopal 201457%—71 of 125 patients responded; 6% met criteria for a complete response. The abstract gives no follicular-lymphoma-specific response rate, only that response rates were similar across subtypes.
PFSAll 125 patients (indolent non-Hodgkin lymphoma subtypes combined)primaryGopal 2014median 11 months—Median duration of response was 12.5 months. Secondary endpoint.
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Idelalisib (experimental)

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

Data table (modelled values)
MonthsIdelalisib
0100.0%
764.3%
1441.4%
2126.6%
2817.1%
Primary publication: Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-18. PubMedDOI

Appears in

Sources

  1. Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-18.

    PubMedDOI