CLL: FDA approves acalabrutinib for first-line and relapsed/refractory CLL


  • David Reilly
  • Oncology drug update
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Takeaway

  • On November 21, the FDA approved acalabrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Why this matters

Study design

  • Approval was based on results of 2 clinical trials:
    • ELEVATE-TN in patients with treatment-naive (TN) CLL (N=535):
      • Acalabrutinib monotherapy vs acalabrutinib+obinutuzumab (G) vs obinutuzumab+chlorambucil (GClb).
    • ASCEND (NCT02970318) in patients with relapsed/refractory CLL (N=310):
      • Acalabrutinib vs investigator’s choice (IC; idelalisib+a rituximab product or bendamustine+a rituximab product).
  • Funding: AstraZeneca.

Key results

  • ELEVATE-TN:
    • Median PFS not estimable (NE) with acalabrutinib (95% CI, 34-NE) vs NE with acalabrutinib+G vs 22.6 (95% CI, 20-28) months with GClb.
    • HR for PFS:
      • Acalabrutinib+G vs GClb: 0.10 (95% CI, 0.06-0.17; P<.0001>
      • Acalabrutinib vs GClb: 0.20 (95% CI, 0.13-0.30; P<.0001>
  • ASCEND:
    • Median PFS NE with acalabrutinib vs 16.5 (95% CI, 14.0-17.1) months with IC.
      • HR for PFS: 0.31 (95% CI, 0.20-0.49; P<.0001>
  • Median OS was not reached in any treatment group.

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