E1912 (IR vs FCR):
Study Design
Progression-Free Survival
Overall Survival

IMBRUVICA® + rituximab vs finite-therapy FCR1,2

Open-label, randomized, phase 3 study

1L PATIENTS WITH CLL
(≤70 YEARS) (N=529)

2:1

RANDOMIZATIONRANDOM-IZATION

IMBRUVICA®* + rituximab† (n=354)

Fludarabine‡ + cyclophosphamide§ + rituximab† (FCR) (n=175)

PRIMARY ENDPOINT:

PFS as assessed by iwCLL criteria

SECONDARY ENDPOINTS:

OS

420 mg once daily until disease progression or unacceptable toxicity.

†Initiated in cycle 2 for the IMBRUVICA® + rituximab arm and in cycle 1 for the FCR arm, and administered at 50 mg/m2 on day 1 of the first cycle, 325 mg/m2 on day 2 of the first cycle, and 500 mg/m2 on day 1 of 5 subsequent cycles, for a total of 6 cycles.

‡25 mg/m2 on days 1, 2, and 3 of cycles 1-6.

§250 mg/m2 on days 1, 2, and 3 of cycles 1-6.

The phase 3 E1912 study was designed and conducted by the Eastern Cooperative Oncology Group and American College of Radiology Imaging Network Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health.2

Select patient characteristics1

Age

Median: 58 years

Range: 28-70 years

ECOG PERFORMANCE STATUS

0-1: 98%

2: 2%

Rai Stage 3 or 4

43%

PATIENTS IN E1912 (N=529)

CLL/SLL WITH HIGH-RISK FACTORS:

59%

MUTATION STATUS

TP53 mutation: 6%

Del 11q: 22%

Unmutated IGHV: 53%

Patients with del 17p were excluded.

Abbreviations

1L=first-line, CLL=chronic lymphocytic leukemia, del=deletion, FCR=fludarabine, cyclophosphamide, and rituximab, IGHV=immunoglobulin heavy-chain variable region gene, IR=IMBRUVICA® + rituximab, iwCLL=International Workshop on Chronic Lymphocytic Leukemia, OS=overall survival, PFS=progression-free survival, SLL=small lymphocytic lymphoma, TP53=tumor protein 53.

References

1. IMBRUVICA® (ibrutinib) Prescribing Information. 2. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib-rituximab or chemoimmunotherapy for chronic lymphocytic leukemia. N Engl J Med. 2019;381(5):432-443.