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Bending the Curve Trial by Trial
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SEQUOIA

Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma

Phase 3N = 590NCT03336333

Population
Untreated CLL or SLL requiring treatment, age 65 or older or age 18 or older with comorbidities, ECOG performance status 0-2
Design
Open-label, multicentre phase 3 study at 153 hospitals in 14 countries and regions; 590 patients enrolled. Patients without del(17)(p13.1) were randomly assigned to zanubrutinib (group A) or bendamustine-rituximab (group B); patients with del(17)(p13.1) were enrolled in group C and received zanubrutinib (not randomised). Primary endpoint PFS per independent review committee in the intention-to-treat population of groups A and B.
Primary endpoint
PFS
Arms
  • Zanubrutinib (group A) (experimental, n = 241): Zanubrutinib 160 mg orally twice per day in 28-day cycles
  • Bendamustine-rituximab (group B) (control, n = 238): Bendamustine 90 mg/m2 on days 1 and 2 for six cycles plus rituximab 375 mg/m2 then 500 mg/m2
  • Zanubrutinib, del(17p) (group C, not randomised) (experimental, n = 111): Zanubrutinib 160 mg orally twice per day in 28-day cycles
People
Tam CS
PFSHR 0.42 (95% CI 0.28–0.63)
Show the numbers
Results reported for SEQUOIA
EndpointAnalysisZanubrutinib (group A) / Zanubrutinib, del(17p) (group C, not randomised)Bendamustine-rituximab (group B)Effect
PFSITT (groups A and B, patients without del(17p))primarymedian follow-up 26.2 monthsTam 2022——HR 0.42 (95% CI 0.28–0.63)P<0.0001Median PFS per independent review committee not reached in either group (group B 95% CI 28.1 months to not estimable). Two-sided P. Group C (del(17p), n=111) is not part of this comparison.
Results reported for SEQUOIA
EndpointAnalysisZanubrutinib (group A) / Zanubrutinib, del(17p) (group C, not randomised)Bendamustine-rituximab (group B)Effect
PFSITT (groups A and B, patients without del(17p))primarymedian follow-up 26.2 monthsTam 2022——HR 0.42 (95% CI 0.28–0.63)P<0.0001Median PFS per independent review committee not reached in either group (group B 95% CI 28.1 months to not estimable). Two-sided P. Group C (del(17p), n=111) is not part of this comparison.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.420.28–0.63
Primary publication: Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043. PubMedDOI

Appears in

Sources

  1. Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, et al. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022;23(8):1031-1043.

    PubMedDOI