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median time to normalization of absolute
lymphocyte count (defined as ≤4.0 K/µL)
was significantly shorter in the combina-
tion cohort (3.0 vs. 8.9 months; p<0.001).
Dr. Burger reported that the safety
profiles were similar between treatment
groups, with the most common AEs being
arterial hypertension, neutropenia, diar-
rhea, and atrial fibrillation. However, more
patients in the ibrutinib monotherapy
group discontinued treatment; of the 56
patients who discontinued, 23 (23%) were
receiving ibrutinib-only and 33 (32%)
were receiving rituximab/ibrutinib. Most
patients stopped treatment because of AEs
(n=28). Six patients developed second ma-
lignancies, including one each of colorectal
cancer, liposarcoma, melanoma, and pleo-
morphic sarcomatoid tumor, and two cases
of new-onset chronic myeloid leukemia.
Five patients died because of renal failure,
cerebral hemorrhage, bowel perforation
with colon hematoma, pneumonia, and
respiratory failure.
Eight patients experienced disease
progression (5 in the monotherapy group
and 3 in the combination arm), and
three patients reported disease transforma-
tion, which occurred between 11 and 16
months on treatment.
The trial is limited by its single-center
design, and, Dr. Burger noted, “longer
follow-up of treatment with anti-CD20
antibodies for a longer period, or with
different anti-CD20 antibodies, may have
a positive impact on PFS and OS.”
The authors report financial relation-
ships with Genentech and Janssen.
REFERENCE
Burger JA, Sivina M, Ferrajoli A, et al. Randomized trial of ibrutinib
versus ibrutinib plus rituximab (Ib+R) in patients with chronic
lymphocytic leukemia (CLL). Abstract #427. Presented at the 2017
American Society of Hematology Annual Meeting, December 10, 2017;
Atlanta, GA.
LONG-TERM efficacy data in both the 2nd- and 3rd-line settings 2
In 2nd-line treatment, after imatinib (n=262 evaluable) a
40 %
of patients
of patients
achieved MCyR by 6 months
(95% CI: 34.1, 46.3)
60 %
achieved MCyR at any time during a
minimum follow-up of 60 months
• 65% of responders had an MCyR
lasting at least 18 months
• 43% of responders had an MCyR
lasting at least 54 months
(95% CI: 53.3, 65.5)
Median duration of MCyR was not reached at the time of analysis
In 3rd-line treatment, after imatinib followed by nilotinib or dasatinib therapy (n=112 evaluable) b
• 26% of patients achieved MCyR by 6 months (95% CI: 18.1, 35.0)
• 40% of patients achieved MCyR at any time during a minimum follow-up of 48 months (95% CI: 31.0, 49.9)
— 64% of responders had an MCyR lasting at least 9 months
— 36% of responders had an MCyR lasting at least 42 months
• Median duration of MCyR was not reached at the time of analysis
LONG-TERM safety data: BOSULIF® has a distinct safety profile
that was established in 5- and 4-year follow-up 2
Diarrhea (82) Abdominal pain (39) Fatigue (25)
Nausea (47) Respiratory tract infection (39) Cough (22)
Thrombocytopenia (42) Anemia (30) Headache (20)
Rash (41) Pyrexia (27) Vomiting (39) Liver test abnormalities (24)
potential hazard to the fetus. Advise females of reproductive potential to use
effective contraceptive measures to prevent pregnancy while being treated with
BOSULIF and for at least 30 days after the final dose.
Adverse Reactions: The most common adverse reactions observed in greater
than or equal to 20% of patients in the Phase 1/2 safety population (N=546) were
diarrhea, nausea, thrombocytopenia, rash, vomiting, abdominal pain, respiratory
tract infection, anemia, pyrexia, liver test abnormalities, fatigue, cough, and
headache. The most common Grade 3/4 adverse reactions and laboratory
abnormalities observed in greater than 10% of patients were thrombocytopenia,
neutropenia, and anemia.
CYP3A Inhibitors and Inducers: Avoid concurrent use with strong or moderate
CYP3A inhibitors or inducers.
For more information on BOSULIF,
visit www.BosulifHCP.com.
Proton Pump Inhibitors: Consider using short-acting antacids or H2 blockers
instead of PPIs to avoid a reduction in BOSULIF exposure. Separate antacid or H2
blocker dosing and BOSULIF dosing by more than 2 hours.
Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, a decision should be made whether to discontinue nursing or BOSULIF,
taking into account the importance of the drug to the mother.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Chronic Myeloid Leukemia V.1.2018. © National Comprehensive Cancer Network, Inc.
2017. All rights reserved. Accessed August 8, 2017. To view the most recent and complete version of
the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their
content or its use or application and disclaims any responsibility for its use or application in any way.
2. BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
Please see brief summary of full Prescribing Information on the following pages.
PP-BOS-USA-0415-01 © 2017 Pfizer Inc. All rights reserved. Printed in USA/September 2017
Median duration of treatment was 26 months
for evaluable patients.
b
Median duration of treatment was 9 months
for evaluable patients.
CI=confidence interval; MCyR=major
cytogenetic response.
a
All grades (%)
Adverse reactions observed in ≥20% of patients in the Phase 1/2 safety population (N=546)
Warnings and precautions include: gastrointestinal toxicity, myelosuppression, hepatic toxicity, fluid retention, renal toxicity,
and embryofetal toxicity. Please see Important Safety Information below for more detail.