ALLIANCE A041202 (I vs BR):
Study Design
Progression-Free Survival

ALLIANCE A041202: STATISTICALLY
SIGNIFICANT PFS WITH IMBRUVICA®
(IBRUTINIB) vs BR1

ALLIANCE A041202: Study Design1,2

Alliance was an open-label, phase 3 trial (N=547) with CLL/SLL ≥65 years of age. Three treatment arms were assessed: IMBRUVICA® 420 mg (n=182), IMBRUVICA® 420 mg + rituximab (n=182), and bendamustine + rituximab (n=183). In the I and I+R arm, IMBRUVICA® 420 mg was taken once daily until disease progression or unacceptable toxicity. In the I+R arm, rituximab was administered at 375 mg/m2 weekly for 4 weeks starting on day 1 of cycle 2, then day 1 of cycles 3 to 6 (28 days each). In the B+R arm, rituximab was administered at 375 mg/m2 on day 0 of cycle 1, then 500 mg/m2 on day 1 of cycles 2 to 6 (28 days each) and bendamustine was administered at 90 mg/m2 days 1 and 2 each 28-day cycle for 6 cycles. The primary endpoint was PFS as assessed by investigators per iwCLL criteria.

These data have not been reviewed by the FDA and are not included in the IMBRUVICA® Prescribing Information.

Statistically significant PFS with IMBRUVICA® vs BR

Progression-free survival (primary endpoint)1,2

Secondary endpoint: OS

  • With a median follow-up of 38 months, there were no significant differences in OS among the arms (P≥0.65 for all pairwise comparison). 30 patients treated with BR crossed over to IMBRUVICA® monotherapy within 1 year after disease progression.1
  • Intent-to-treat PFS analysis from Supplement to Woyach et al, 2018. From the New England Journal of Medicine, Jennifer A. Woyach, et al., "lbrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL," v379, Copyright © 2018, Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

Abbreviations

BR=bendamustine + rituximab, CI=confidence interval,  CLL=chronic lymphocytic leukemia, HR=hazard ratio, I=IMBRUVICA®, IR=IMBRUVICA® + rituximab, ITT=intent to treat, iwCLL=International Workshop on Chronic Lymphocytic Leukemia, OS=overall survival, PFS=progression-free survival, SLL=small lymphocytic lymphoma.

References

1. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517-2528. 2. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherarpy in older patients with untreated CLL. Supplementary appendix. N Engl J Med. 2018;379(26):2517-2528.