Skip to content
Bending the Curve Trial by Trial
?

ASCEND

ASCEND: phase III, randomized trial of acalabrutinib versus idelalisib plus rituximab or bendamustine plus rituximab in relapsed or refractory chronic lymphocytic leukemia

Phase 3N = 310NCT02970318

Population
Relapsed or refractory CLL, age 18 or older; median of two prior therapies (range 1-10)
Design
Global, multicentre, open-label phase 3 study; patients aged 18 or older with relapsed or refractory CLL randomly assigned 1:1, stratified by del(17p), ECOG performance status and number of prior therapies, to acalabrutinib monotherapy or investigator's choice of idelalisib-rituximab or bendamustine-rituximab. Primary endpoint PFS by independent review committee in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Acalabrutinib (experimental, n = 155): Acalabrutinib monotherapy
  • Investigator's choice (control, n = 155): Idelalisib plus rituximab (n=119) or bendamustine plus rituximab (n=36)
People
Ghia P, senior author Jurczak W
PFSHR 0.31 (95% CI 0.20–0.49)Δ 12-month PFS+20 points
Show the numbers
Results reported for ASCEND
EndpointAnalysisAcalabrutinibInvestigator's choiceEffect
PFSprimarymedian follow-up 16.1 monthsGhia 202088% at 12 mo (81–92%)median 16.5 months (14.0–17.1); 68% at 12 mo (59–75%)HR 0.31 (95% CI 0.20–0.49)P<.0001Median PFS not reached with acalabrutinib. Estimated PFS at 12 months. PFS assessed by independent review committee.
Results reported for ASCEND
EndpointAnalysisAcalabrutinibInvestigator's choiceEffect
PFSprimarymedian follow-up 16.1 monthsGhia 202088% at 12 mo (81–92%)median 16.5 months (14.0–17.1); 68% at 12 mo (59–75%)HR 0.31 (95% CI 0.20–0.49)P<.0001Median PFS not reached with acalabrutinib. Estimated PFS at 12 months. PFS assessed by independent review committee.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.310.2–0.49
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Investigator's choice (control)

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

Data table (modelled values)
MonthsInvestigator's choice
0100.0%
1065.7%
2141.4%
3127.2%
4117.9%
Primary publication: Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020;38(25):2849-2861. PubMedDOI

Appears in

Sources

  1. Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020;38(25):2849-2861.

    PubMedDOI