iLLUMINATE™ (IG vs GClb):
Study Design
Progression-Free Survival
Overall Response Rate

iLLUMINATE™: IMBRUVICA® + obinutuzumab studied across several patient types1

Randomized, multicenter, open-label, phase 3 iLLUMINATE™ trial1,2

TREATMENT-NAÏVE PATIENTS WITH CLL/SLL ≥65 YEARS (N=229)

or

TREATMENT-NAÏVE PATIENTS WITH CLL/SLL <65 YEARS WITH AT LEAST ONE OF THE FOLLOWING CONDITIONS:

  • Coexisting medical conditions, or
  • Reduced renal function as measured by creatinine clearance ≤70 mL/min, or
  • Del 17p/TP53 mutation

1:1

RANDOMIZATIONRANDOM-IZATION

IMBRUVICA® 420 mg once daily until disease progression or unacceptable toxicity + obinutuzumab* (n=113)

Chlorambucil† + obinutuzumab*‡ (n=116)

PRIMARY ENDPOINT:

PFS per IRC

ADDITIONAL ENDPOINTS INCLUDE:

PFS in the high-risk population (unmutated IGHV, del 17p/TP53 mutation, or del 11q)

ORR

In both arms, patients received 1000 mg of obinutuzumab on Days 1, 8, and 15 of the first cycle, followed by 1000 mg on the first day of 5 subsequent cycles (total of 6 cycles, 28 days each). The first dose of obinutuzumab was divided between Day 1 (100 mg) and Day 2 (900 mg).1

†Chlorambucil was administered at a dose of 0.5 mg/kg on Days 1 and 15 of each 28-day cycle for 6 cycles.1

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

PFS and ORR (CR and PR) were assessed by an IRC per iwCLL criteria2-4

iLLUMINATE™ included patients with select high-risk characteristics1,2

Age

Median: 71 years

Range: 40-86 years

<65 years: 20%

≥65 years: 80%

ECOG PS

0: 48%

1 or 2 : 52%

RAI STAGE

0, I, or II: 48%

III or IV: 52%

PATIENTS IN iLLUMINATETM(N=229)

CLL/SLL WITH HIGH-RISK FACTORS:

65%

High-risk factor

Del11q: 15%

Del 17p: 14%

Del 17p/TP53:18%

Unmutated IGHV: 54%

Most common reasons for treatment initiation were1:

  • Lymphadenopathy (38%)
  • Night sweats (34%)
  • Progressive marrow failure (31%)
  • Fatigue (29%)
  • Splenomegaly (25%)
  • Progressive lymphocytosis (21%)

Abbreviations

CLL=chronic lymphocytic leukemia, CR=complete response, del=deletion, ECOG PS=Eastern Cooperative Oncology Group Performance Status, IG=IMBRUVICA® + obinutuzumab, IGHV=immunoglobulin heavy-chain variable region gene, IRC=independent review committee, iwCLL=International Workshop on Chronic Lymphocytic Leukemia, GClb=obinutuzumab + chlorambucil, ORR=overall response rate, PFS=progression-free survival, PR=partial response, SLL=small lymphocytic lymphoma, TP53=tumor protein 53.

References

1. IMBRUVICA® (ibrutinib) Prescribing Information. 2. Moreno C, Griel R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia: primary results from the randomised phase 3 iLLUMINATE study. Lancet Oncol. 2019;20(1):43-56. 3. Hallek M, Cheson BD, Catovsky D, et al; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute—Working Group 1996 guidelines. Blood. 2008;111(12):5446-5456. 4. Hallek M, Cheson BD, Catovsky D, et al. Response assessment in chronic lymphocytic leukemia treated with novel agents causing an increase of peripheral blood lymphocytes (e-Letter). Blood. 2012;119(23):5348.