SEQUOIA and ALPINE: 2 GLOBAL PHASE 3 TRIALS in CLL

First line

SEQUOIA (STUDY 304):
DESIGNED TO EVALUATE SUPERIORITY OF BRUKINSA
VS BR IN FIRST-LINE CLL1,2

A global Phase 3, randomized, open-label, multicenter trial conducted in patients with previously untreated CLL/SLL.
Trial was initiated in 2017.*

Cohort 2 rationale: Because patients with CLL/SLL whose tumors exhibit del(17p) have an unfavorable prognosis and respond poorly to standard chemoimmunotherapy, those with del(17p) mutations were assigned to receive BRUKINSA in this separate single-arm exploratory analysis.

*The primary endpoint was PFS per IRC in the ITT population in the BRUKINSA arm and the BR arm, with minimum 2-sided alpha of 0.05 for superiority.

Patients received bendamustine 90 mg/m2/day on the first 2 days of each cycle for 6 cycles, rituximab 375 mg/m2 for Cycle 1, and rituximab 500 mg/m2 for Cycles 2-6.

BID=twice daily; BR=bendamustine+rituximab; CLL=chronic lymphocytic leukemia; IRC=independent review committee; ITT=intent to treat; iWCLL=International Workshop on Chronic Lymphocytic Leukemia; ORR=overall response rate; PD=progressive disease; PFS=progression-free survival; SLL=small lymphocytic lymphoma.

BASELINE PATIENT CHARACTERISTICS IN A RANGE OF PATIENTS,
INCLUDING THOSE WITH AND WITHOUT DEL(17p) MUTATIONS1-3

*Cardiac disorders is a grouped term of 33 conditions that includes atrial fibrillation, myocardial ischemia, coronary artery disease, myocardial infarction, cardiac arrest, cardiac failure, acute coronary syndrome, angina pectoris, tachycardia, and bradycardia.

Afib=atrial fibrillation; BR=bendamustine+rituximab; ECOG PS=Eastern Cooperative Oncology Group performance status.

Second line

ALPINE (STUDY 305):
DESIGNED TO EVALUATE SUPERIORITY OF BRUKINSA vs IBRUTINIB IN SECOND-LINE CLL1,4

A global Phase 3, randomized, open-label, multicenter trial conducted in patients with relapsed/refractory CLL/SLL who received ≥1 prior systemic therapy.*




* Statistical analysis for PFS and ORR were initially conducted for noninferiority. When noninferiority was met, superiority was tested. Assessments were made by the investigators, with similar results by IRC.

Afib=atrial fibrillation; BID=twice daily; CLL=chronic lymphocytic leukemia; IRC=independent review committee; iWCLL=International Workshop on Chronic Lymphocytic Leukemia; ORR=overall response rate; PD=progressive disease; PFS=progression-free survival; QD=once daily; SLL=small lymphocytic lymphoma.

BRUKINSA WAS STUDIED IN A RANGE OF PATIENTS,
INCLUDING THOSE WITH AND WITHOUT MUTATIONS ASSOCIATED WITH POOR PROGNOSIS4,5



*Values based on patients enrolled in the ITT population.

Complex karyotype is defined as having 3 or more abnormalities.

Cardiac disorders is a grouped term that includes atrial fibrillation, myocardial ischemia, coronary artery disease, myocardial infarction, arrhythmia, atrial flutter, cardiac failure, tachycardia, bradycardia, and cardiac aneurysm.

Afib=atrial fibrillation; ECOG PS=Eastern Cooperative Oncology Group performance status; iMiD=immunomodulatory drug; ITT=intent to treat.

Long-term data

STUDY 003:
LONG-TERM DATA IN
FIRST- AND SECOND-LINE CLL6,7

A global supportive Phase 1/2, open-label, single-arm trial that included patients with treatment-naïve or relapsed/refractory CLL/SLL and evaluated ~4 years of safety and ~3 years of efficacy data*





The median follow-up in
Study 003 was 47 months

STUDY 003:
STUDIED IN A RANGE
OF PATIENTS6



*Exploratory long-term analysis; all data are descriptive in nature.

BID=twice daily; CLL=chronic lymphocytic leukemia; ECOG PS=Eastern Cooperative Oncology Group performance status; IRC=independent review committee; iWCLL=International Workshop on Chronic Lymphocytic Leukemia; ORR=overall response rate; PFS=progression-free survival; QD=once daily; R/R=relapsed/refractory; SLL=small lymphocytic lymphoma; TN=treatment naïve.

EFFICACY ACROSS
LINES OF THERAPY
Efficacy
Established
Safety Profile
Safety
Personalized
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