RESONATE™-2: IMBRUVICA® FOR FRONTLINE CLL/SLL1

RESONATE™-2: Study Design1,2

Randomized, multicenter, open-label, phase 3 RESONATE™-2 CLL clinical trial (N=269)

PFS and ORR (CR and PR) were assessed by an IRC per iwCLL criteria2

*Patients on chlorambucil were able to cross over to IMBRUVICA® after IRC-confirmed disease progression.

Patients with IRC-confirmed progressive disease were enrolled in an extension study for follow-up and collection of long-term safety and efficacy data and to allow for second-line treatment per investigator’s choice (including IMBRUVICA® for patients progressing on chlorambucil per iwCLL criteria).

RESONATE™-2 included patients with select high-risk characteristics1-3

Selected patient characteristics

The most common reasons for treatment initiation were1:

  • Progressive marrow failure demonstrated by anemia and/or thrombocytopenia (38%)
  • Progressive or symptomatic lymphadenopathy (37%)
  • Progressive or symptomatic splenomegaly (30%)
  • Fatigue (27%)
  • Night sweats (25%)

RESONATE™-2 concomitant medication of clinical interest (for ibrutinib)

Please see IMBRUVICA® WARNINGS AND PRECAUTIONS about hemorrhage; infections; cardiac arrhythmias, cardiac failure, and sudden death; hypertension; cytopenias; second primary malignancies; hepatotoxicity, including drug-induced liver injury (DILI); tumor lysis syndrome; and embryo-fetal toxicity.

Supportive medications in accordance with standard practice were permitted and prespecified in the RESONATE™-2 study protocol.5

Subjects concomitant medications were collected from screening through study treatment phase and up to 30 days after the last dose of either treatment arm. No data regarding duration of use, safety, or tolerability was reported in this analysis.5

Abbreviations

CLL=chronic lymphocytic leukemia, CR=complete response, del=deletion, ECOG=Eastern Cooperative Oncology Group, IGHV=immunoglobulin heavy chain variable region gene, IRC=independent review committee, iwCLL=International Workshop on Chronic Lymphocytic Leukemia, LTFU=long-term follow-up, ORR=overall response rate, OS=overall survival, PFS=progression-free survival, PR=partial response, SLL=small lymphocytic lymphoma.

References

1IMBRUVICA® (ibrutinib) Prescribing Information. 2Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425-2437. 3Barr PM, Owen C, Robak T, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Supplemental tables and figures. Blood Adv. 2022;6(11):3440-3450. 4Barr PM, Owen C, Robak T, et al. Up to 8-year follow-up from RESONATE-2: first-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv. 2022;6(11):3440-3450. 5Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. Supplementary Protocol. N Engl J Med. 2015;373(25):2425-2437.