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Bending the Curve Trial by Trial
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DUO

The phase 3 DUO trial: duvelisib versus ofatumumab in relapsed and refractory CLL/SLL

Phase 3N = 319NCT02004522

Population
Relapsed or refractory CLL or SLL
Design
Global phase 3 randomised study; patients randomised 1:1 to oral duvelisib 25 mg twice daily (n=160) or intravenous ofatumumab (n=159). The study met its primary endpoint of PFS per independent review committee.
Primary endpoint
PFS
Arms
  • Duvelisib (experimental, n = 160): Oral duvelisib 25 mg twice daily
  • Ofatumumab (control, n = 159): Intravenous ofatumumab
People
Flinn IW
PFSHR 0.52Δ median PFS+3.4 monthsPFSHR 0.4Δ ORR+29 points
Show the numbers
Results reported for DUO
EndpointAnalysisDuvelisibOfatumumabEffect
PFSAll randomised patients; the abstract does not state the analysis populationprimaryFlinn 2018median 13.3 monthsmedian 9.9 monthsHR 0.52P<.0001No confidence interval for the hazard ratio in the abstract.
PFSPatients with del(17p) and/or TP53 mutation (subgroup)primaryFlinn 2018——HR 0.4P=0.0002Subgroup analysis; hazard ratio for PFS per independent review committee.
ORRAll randomised patients; the abstract does not state the analysis populationprimaryFlinn 201874%45%P<.0001Higher with duvelisib regardless of del(17p) status (abstract).
Results reported for DUO
EndpointAnalysisDuvelisibOfatumumabEffect
PFSAll randomised patients; the abstract does not state the analysis populationprimaryFlinn 2018median 13.3 monthsmedian 9.9 monthsHR 0.52P<.0001No confidence interval for the hazard ratio in the abstract.
PFSPatients with del(17p) and/or TP53 mutation (subgroup)primaryFlinn 2018——HR 0.4P=0.0002Subgroup analysis; hazard ratio for PFS per independent review committee.
ORRAll randomised patients; the abstract does not state the analysis populationprimaryFlinn 201874%45%P<.0001Higher with duvelisib regardless of del(17p) status (abstract).
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Duvelisib (experimental)
  • Ofatumumab (control)

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

Data table (modelled values)
MonthsDuvelisibOfatumumab
0100.0%100.0%
865.9%57.1%
1741.2%30.4%
2527.2%17.4%
3317.9%9.9%
Primary publication: Flinn IW, Hillmen P, Montillo M, Nagy Z, Illés Á, Etienne G, et al. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018;132(23):2446-2455. PubMedDOI

Appears in

Sources

  1. Flinn IW, Hillmen P, Montillo M, Nagy Z, Illés Á, Etienne G, et al. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018;132(23):2446-2455.

    PubMedDOI