RESONATE™: IMBRUVICA® FOR RELAPSED/‌REFRACTORY CLL/SLL1

RESONATE™: ORR as monotherapy for previously treated CLL/SLL1

Secondary endpoint: Overall response rate IMBRUVICA® vs ofatumumab1,2

Efficacy Resonate ORR Chart

ORR was assessed by an IRC per iwCLL criteria.1-4

  • Median follow-up was 9.4 months2
  • None of the patients achieved a complete response1

ORR in patients with relapsed/refractory del 17p CLL/SLL1

  • Median follow-up was 9.7 months5
  • The ORR in patients with previously treated del 17p CLL/SLL receiving IMBRUVICA® (n=63) was 48% vs 5% with ofatumumab (n=64). All responses were partial responses1

Long-term investigator-assessed follow-up1

  • With an overall follow-up of 63 months, the ORR as assessed by investigators was 87.2% in the IMBRUVICA® arm versus 22.4% in the ofatumumab arm1
  • With an overall follow-up of 63 months, the ORR as assessed by investigators in patients with del 17p was 88.9% in the IMBRUVICA® arm versus 18.8% in the ofatumumab arm1

Abbreviations

CLL=chronic lymphocytic leukemia, del=deletion, IRC=independent review committee, iwCLL=International Workshop on CLL, ORR=overall response rate, SLL=small lymphocytic lymphoma.

References

1IMBRUVICA® (ibrutinib) Prescribing Information. 2Byrd JC, Brown JR, O’Brien S, et al; for the RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014;371(3):213-223. 3Hallek M, Cheson BD, Catovsky D, et al; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute—Working Group 1996 guidelines. Blood. 2008;111(12):5446-5456. 4Hallek M, Cheson BD, Catovsky D, et al. Response assessment in chronic lymphocytic leukemia treated with novel agents causing an increase of peripheral blood lymphocytes (e-Letter). Blood. 2012;119(23):5348. 5Data on file. Pharmacyclics LLC.