Long-Term Studies Assessing Outcomes of Ibrutinib Therapy in Patients With Del(11q) Chronic Lymphocytic Leukemia Academic Article uri icon

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abstract

  • BACKGROUND: Certain genomic features, such as del(11q), expression of unmutated immunoglobulin heavy-chain variable region (IGHV) gene, or complex karyotype, predict poorer outcomes to chemotherapy in patients with chronic lymphocytic leukemia (CLL). PATIENTS AND METHODS: We examined the pooled long-term follow-up data from PCYC-1115 (RESONATE-2), PCYC-1112 (RESONATE), and CLL3001 (HELIOS), comprising a total of 1238 subjects, to determine the prognostic significance of these markers in patients treated with ibrutinib. RESULTS: With a median follow-up of 47 months, ibrutinib-treated patients had longer progression-free survival (PFS) than patients treated in the comparator arm, regardless of genomic risk factors. Among patients treated with ibrutinib, we found that high-risk genomic features were not associated with shorter PFS (63-75% across all subgroups at 42 months) or overall survival (79-83% across all subgroups at 42 months). Surprisingly, we observed that ibrutinib-treated patients with del(11q) actually had a significantly longer PFS than ibrutinib-treated patients without del(11q) (42-month PFS rate 70% vs. 65%, P = .02). CONCLUSION: These analyses not only demonstrate that genomic risk factors previously associated with poor outcomes lose their adverse prognostic significance but also that del(11q) can be associated with a superior PFS with ibrutinib therapy.

authors

  • Kipps, Thomas J
  • Fraser, Graeme
  • Coutre, Steven E
  • Brown, Jennifer R
  • Barrientos, Jacqueline C
  • Barr, Paul M
  • Byrd, John C
  • O’Brien, Susan M
  • Dilhuydy, Marie-Sarah
  • Hillmen, Peter
  • Jaeger, Ulrich
  • Moreno, Carol
  • Cramer, Paula
  • Stilgenbauer, Stephan
  • Chanan-Khan, Asher A
  • Mahler, Michelle
  • Salman, Mariya
  • Eckert, Karl
  • Solman, Isabelle G
  • Balasubramanian, Sriram
  • Cheng, Mei
  • Londhe, Anil
  • Ninomoto, Joi
  • Howes, Angela
  • James, Danelle F
  • Hallek, Michael

publication date

  • November 2019