NOW APPROVED IN Chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL)

24-hour inhibition of BTK was maintained at 100% in PBMCs and 94% to 100% in lymph nodes when taken at the recommended total daily dose of 320 mg. The clinical significance of 100% inhibition has not been established.1,2

BRUKINSA: SUPERIOR
EFFICACY ACROSS LINES
OF THERAPY IN CLL1,3

  • Superior PFS vs BR in 1L
  • Superior PFS and ORR vs ibrutinib in 2L
  • Low rates of cardiac events, including afib/flutter

BRUKINSA was designed to meet the challenges of BTK inhibition,
including in adult patients with CLL/SLL1

EFFICACY DEMONSTRATED
ACROSS LINES OF THERAPY


 
EFFICACY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENT EFFICACY IN AN
ADDITIONAL PHASE 1/2 TRIAL

EFFICACY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENT EFFICACY IN AN
ADDITIONAL PHASE 1/2 TRIAL


SEQUOIA (Study 304) assessed the efficacy and safety of BRUKINSA in 589 adult patients with treatment-naïve CLL/SLL. SEQUOIA was a global Phase 3, randomized, open-label, multicenter study.1

ALPINE (Study 305) assessed the efficacy and safety of BRUKINSA in 652 adult patients with relapsed/refractory CLL/SLL who had received ≥1 prior systemic therapy. ALPINE was a global Phase 3, randomized, open-label, multicenter trial.1,3

AU-003 assessed the long-term safety and efficacy of BRUKINSA in 123 adult patients with treatment-naïve or relapsed/refractory CLL/SLL. AU-003 was a global supportive Phase 1/2, open-label, multicenter, single-arm trial.6


1L=first line; 2L=second line; afib=atrial fibrillation; BR=bendamustine+rituximab; BTK=Bruton's tyrosine kinase; CI=confidence interval; CLL=chronic lymphocytic leukemia; HR=hazard ratio; ORR=overall response rate; PBMCs=peripheral blood mononuclear cells; PFS=progression-free survival; SLL=small lymphocytic lymphoma.

CONSISTENTLY LOW RATES OF AFIB/FLUTTER AND
DISCONTINUATION ACROSS TRIALS




 
CONSISTENCY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENCY IN AN ADDITIONAL
TRIAL (Phase 1/2)

 
CONSISTENCY IN 2 GLOBAL PHASE 3 TRIALS

CONSISTENCY IN AN ADDITIONAL
TRIAL (Phase 1/2)


1L=first line; 2L=second line; AE=adverse event; afib=atrial fibrillation; BR=bendamustine+rituximab.