ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the
schedule of several data presentations on Iclusig® (ponatinib) that
will take place at the 56th Annual Meeting of the American Society
of Hematology (ASH) being held in San Francisco, December 6 to 9,
2014. A total of 17 abstracts were accepted at ASH. The schedule
and meeting location for key sessions at ASH, together with the
abstract information, are listed below:
Oral Presentations:
Title:
Achieving Early Landmark Response is
Predictive of Outcomesin Heavily Pretreated Patients with Chronic
Phase Chronic MyeloidLeukemia (CP-CML) Treated with Ponatinib
Oral Session::
Chronic Myeloid Leukemia – Prognosis and
Therapy
Date & Time:
Monday, December 8, 2014, 2:45 p.m.,
Presentation at 3:00 p.m.
Abstract No.:
72705
Presenter:
Martin C. Müller, M.D. (Medical Clinic,
University Hospital Mannheim,Mannheim, Germany)
Location: Moscone Center, West Building 3001-3003-3014-3016
Title:
A Phase 3 Trial of Ponatinib Compared with
Imatinib in Patients withNewly Diagnosed Chronic Myeloid Leukemia
in Chronic Phase CP-CML
Oral Session: Chronic Myeloid Leukemia – Prognosis and Therapy Date
& Time: Monday, December 8, 2014, 2:45 p.m., Presentation at
3:15 p.m. Abstract No.: 70542 Author: Jeff H. Lipton, Ph.D., M.D.
(Princess Margaret Hospital, Toronto) Location: Moscone Center,
West Building 3001-3003-3014-3016
Clinical Poster Presentations:
Title:
High-Resolution Analysis of the
Relationship between Dose andMolecular Response in CP-CML Patients
Treated with Ponatinib orImatinib
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster II Date
& Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m. Abstract
No.: 72342 Author: Justin R. Pritchard, Ph.D. (ARIAD
Pharmaceuticals, Inc.) Location: Moscone Center, West Building,
Level 1 Title:
Long-term Follow-up of Ponatinib Efficacy
and Safety in the Phase2 PACE Trial
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster III Date
& Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m. Abstract
No.: 73035 Presenter:
Jorge E. Cortes, M.D. (The University of
Texas MD AndersonCancer Center)
Location: Moscone Center, West Building, Level 1 Title:
Long-Term Follow-up of a Phase 1 Study of
Ponatinib in Patients withChronic-Phase Chronic Myeloid Leukemia
(CP-CML)
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster III Date
& Time: Monday, December 8, 2014 at 6:00 – 8:00 p.m. Abstract
No.: 73603 Presenter: Moshe Talpaz, M.D. (University of Michigan
Comprehensive Cancer Center) Location: Moscone Center, West
Building, Level 1 Title:
Ponatinib Efficacy and Safety in Patients
with the T315I Mutation:Long-Term Follow-up of Phase 1 and Phase 2
(PACE) Trials
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster III Date
& Time: Monday, December 8, 2014, 6:00 – 8:00 p.m. Abstract
No.: 70201 Presenter: Michael J. Mauro, M.D. (Memorial Sloan
Kettering Cancer Center) Location: Moscone Center, West Building,
Level 1 Title:
Impact of Dose Intensity of Ponatinib on
Selected Adverse Events:Multivariate Analyses from a Pooled
Population of Clinical Trial Patients
Poster Session: Chronic Myeloid Leukemia –Therapy: Poster III Date
& Time: Monday, December 8, 2014, 6:00 – 8:00 p.m. Abstract
No.: 67858 Presenter: Ronald K. Knickerbocker, Ph.D. (ARIAD
Pharmaceuticals, Inc.) Location: Moscone Center, West Building,
Level 1 Title:
Ponatinib as Frontline Therapy for
Patients with ChronicMyeloid Leukemia in Chronic Phase
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster III Date
& Time: Monday, December 8, 2014, 6:00 – 8:00 p.m. Abstract
No.: 74084 Presenter:
Preetesh Jain, M.D., Ph.D. (The University
of Texas MD AndersonCancer Center)
Location: Moscone Center, West Building, Level 1
Preclinical Poster
Presentations:
Title:
Comparative TKI Profiling Analyses to
Explore Potential Mechanismsof Ponatinib-Associated Arterial
Thrombotic Events
Poster Session:
Chronic Myeloid Leukemia – Biology and
Pathophysiology, ExcludingTherapy: Poster 1
Date & Time: Saturday, December 6, 2014, 5:30 – 7:30 p.m.
Abstract No.: 73920 Presenter: Victor M. Rivera, Ph.D. (ARIAD
Pharmaceuticals, Inc.) Location: Moscone Center, West Building,
Level 1
Health Economics and Outcomes Research
Poster Presentations:
Title:
Benefit-Risk of Ponatinib vs. Bosutinib in
Chronic Phase ChronicMyeloid Leukemia Patients who Failed Two Prior
Tyrosine KinaseInhibitors: an indirect comparison
Poster Session:
Chronic Myeloid Leukemia - Therapy:Poster
II
Date & Time: Sunday, December 7, 2014, 6:00 – 8:00 p.m.
Abstract No.: 74548 Presenter: Moshe Yair Levy, M.D. (Baylor
University Med Center, Dallas, TX) Location: Moscone Center, West
Building, Level 1 Title:
Comparative Efficacy Among 3rd Line
Post-Imatinib Chronic Phase ChronicMyeloid Leukemia Patients after
Failure of Dasatinib or Nilotinib TyrosineKinase Inhibitors
Poster Session: Chronic Myeloid Leukemia - Therapy: Poster III Date
& Time: Monday, December 8, 2014, 6:00 – 8:00 p.m. Abstract
No.: 73075 Presenter:
Jeffrey H. Lipton, M.D., Ph.D., (Ontario
Cancer Institute,Princess Margaret Hospital)
Location: Moscone Center, West Building, Level 1
About Iclusig® (ponatinib) tablets
Iclusig is approved in the U.S., EU and Switzerland. Iclusig is
a kinase inhibitor indicated in the U.S. for the:
• Treatment of adult patients with T315I-positive chronic
myeloid leukemia (chronic phase, accelerated phase, or blast phase)
or T315I-positive Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL).
•Treatment of adult patients with chronic phase, accelerated
phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom
no other tyrosine kinase inhibitor (TKI) therapy is indicated.
IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED
WARNING
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and
HEPATOTOXICITY
See full prescribing information for complete boxed
warning
- Vascular Occlusion: Arterial and
venous thrombosis and occlusions have occurred in at least 27% of
Iclusig treated patients, including fatal myocardial infarction,
stroke, stenosis of large arterial vessels of the brain, severe
peripheral vascular disease, and the need for urgent
revascularization procedures. Patients with and without
cardiovascular risk factors, including patients less than 50 years
old, experienced these events. Monitor for evidence of
thromboembolism and vascular occlusion. Interrupt or stop Iclusig
immediately for vascular occlusion. A benefit risk consideration
should guide a decision to restart Iclusig therapy.
- Heart Failure, including fatalities,
occurred in 8% of Iclusig-treated patients. Monitor cardiac
function. Interrupt or stop Iclusig for new or worsening heart
failure.
- Hepatotoxicity, liver failure and
death have occurred in Iclusig-treated patients. Monitor hepatic
function. Interrupt Iclusig if hepatotoxicity is
suspected.
Vascular Occlusion: Arterial and venous thrombosis and
occlusions, including fatal myocardial infarction, stroke, stenosis
of large arterial vessels of the brain, severe peripheral vascular
disease, and the need for urgent revascularization procedures have
occurred in at least 27% of Iclusig-treated patients from the phase
1 and phase 2 trials. Iclusig can also cause recurrent or
multi-site vascular occlusion. Overall, 20% of Iclusig-treated
patients experienced an arterial occlusion and thrombosis event of
any grade. Fatal and life-threatening vascular occlusion has
occurred within 2 weeks of starting Iclusig treatment and in
patients treated with average daily dose intensities as low as 15
mg per day. The median time to onset of the first vascular
occlusion event was 5 months. Patients with and without
cardiovascular risk factors have experienced vascular occlusion
although these events were more frequent with increasing age and in
patients with prior history of ischemia, hypertension, diabetes, or
hyperlipidemia. Interrupt or stop Iclusig immediately in patients
who develop vascular occlusion events.
Heart Failure: Fatal and serious heart failure or left
ventricular dysfunction occurred in 5% of Iclusig-treated patients
(22/449). Eight percent of patients (35/449) experienced any grade
of heart failure or left ventricular dysfunction. Monitor patients
for signs or symptoms consistent with heart failure and treat as
clinically indicated, including interruption of Iclusig. Consider
discontinuation of Iclusig in patients who develop serious heart
failure.
Hepatotoxicity: Iclusig can cause hepatotoxicity,
including liver failure and death. Fulminant hepatic failure
leading to death occurred in an Iclusig-treated patient within one
week of starting Iclusig. Two additional fatal cases of acute liver
failure also occurred. The fatal cases occurred in patients with
blast phase CML (BP-CML) or Philadelphia chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Severe hepatotoxicity occurred in
all disease cohorts. Iclusig treatment may result in elevation in
ALT, AST, or both. Monitor liver function tests at baseline, then
at least monthly or as clinically indicated. Interrupt, reduce or
discontinue Iclusig as clinically indicated.
Hypertension: Treatment-emergent hypertension (defined as
systolic BP≥140 mm Hg or diastolic BP≥90 mm Hg on at least one
occasion) occurred in 67% of patients (300/449). Eight patients
treated with Iclusig (2%) experienced treatment-emergent
symptomatic hypertension as a serious adverse reaction, including
one patient (<1%) with hypertensive crisis. Patients may require
urgent clinical intervention for hypertension associated with
confusion, headache, chest pain, or shortness of breath. In 131
patients with Stage 1 hypertension at baseline, 61% (80/131)
developed Stage 2 hypertension. Monitor and manage blood pressure
elevations during Iclusig use and treat hypertension to normalize
blood pressure. Interrupt, dose reduce, or stop Iclusig if
hypertension is not medically controlled.
Pancreatitis: Clinical pancreatitis occurred in 6%
(28/449) of patients (5% Grade 3) treated with Iclusig.
Pancreatitis resulted in discontinuation or treatment interruption
in 6% of patients (25/449). The incidence of treatment-emergent
lipase elevation was 41%. Check serum lipase every 2 weeks for the
first 2 months and then monthly thereafter or as clinically
indicated. Consider additional serum lipase monitoring in patients
with a history of pancreatitis or alcohol abuse. Dose interruption
or reduction may be required. In cases where lipase elevations are
accompanied by abdominal symptoms, interrupt treatment with Iclusig
and evaluate patients for pancreatitis. Do not consider restarting
Iclusig until patients have complete resolution of symptoms and
lipase levels are less than 1.5 x ULN.
Neuropathy: Peripheral and cranial neuropathy have
occurred in Iclusig-treated patients. Overall, 13% (59/449) of
Iclusig-treated patients experienced a peripheral neuropathy event
of any grade (2%, grade 3/4). In clinical trials, the most common
peripheral neuropathies reported were peripheral neuropathy (4%,
18/449), paresthesia (4%, 17/449), hypoesthesia (2%, 11/449), and
hyperesthesia (1%, 5/449). Cranial neuropathy developed in 1%
(6/449) of Iclusig-treated patients (<1% grade 3/4). Of the
patients who developed neuropathy, 31% (20/65) developed neuropathy
during the first month of treatment. Monitor patients for symptoms
of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia,
discomfort, a burning sensation, neuropathic pain or weakness.
Consider interrupting Iclusig and evaluate if neuropathy is
suspected.
Ocular Toxicity: Serious ocular toxicities leading to
blindness or blurred vision have occurred in Iclusig-treated
patients. Retinal toxicities including macular edema, retinal vein
occlusion, and retinal hemorrhage occurred in 3% of Iclusig-treated
patients. Conjunctival or corneal irritation, dry eye, or eye pain
occurred in 13% of patients. Visual blurring occurred in 6% of the
patients. Other ocular toxicities include cataracts, glaucoma,
iritis, iridocyclitis, and ulcerative keratitis. Conduct
comprehensive eye exams at baseline and periodically during
treatment.
Hemorrhage: Serious bleeding events, including
fatalities, occurred in 5% (22/449) of patients treated with
Iclusig. Hemorrhagic events occurred in 24% of patients. The
incidence of serious bleeding events was higher in patients with
accelerated phase CML (AP-CML), BP-CML, and Ph+ ALL. Most
hemorrhagic events, but not all occurred in patients with grade 4
thrombocytopenia. Interrupt Iclusig for serious or severe
hemorrhage and evaluate.
Fluid Retention: Serious fluid retention events occurred
in 3% (13/449) of patients treated with Iclusig. One instance of
brain edema was fatal. In total, fluid retention occurred in 23% of
the patients. The most common fluid retention events were
peripheral edema (16%), pleural effusion (7%), and pericardial
effusion (3%). Monitor patients for fluid retention and manage
patients as clinically indicated. Interrupt, reduce, or discontinue
Iclusig as clinically indicated.
Cardiac Arrhythmias: Symptomatic bradyarrhythmias that
led to a requirement for pacemaker implantation occurred in 1%
(3/449) of Iclusig-treated patients. Advise patients to report
signs and symptoms suggestive of slow heart rate (fainting,
dizziness, or chest pain). Supraventricular tachyarrhythmias
occurred in 5% (25/449) of Iclusig-treated patients. Atrial
fibrillation was the most common supraventricular tachyarrhythmia
and occurred in 20 patients. For 13 patients, the event led to
hospitalization. Advise patients to report signs and symptoms of
rapid heart rate (palpitations, dizziness). Interrupt Iclusig and
evaluate.
Myelosuppression: Severe (grade 3 or 4) myelosuppression
occurred in 48% (215/449) of patients treated with Iclusig. The
incidence of these events was greater in patients with AP-CML,
BP-CML and Ph+ ALL than in patients with CP-CML. Obtain complete
blood counts every 2 weeks for the first 3 months and then monthly
or as clinically indicated, and adjust the dose as recommended.
Tumor Lysis Syndrome: Two patients (<1%) with advanced
disease (AP-CML, BP-CML, or Ph+ ALL) treated with Iclusig developed
serious tumor lysis syndrome. Hyperuricemia occurred in 7% (30/449)
of patients overall; the majority had CP-CML (19 patients). Due to
the potential for tumor lysis syndrome in patients with advanced
disease, ensure adequate hydration and treat high uric acid levels
prior to initiating therapy with Iclusig.
Compromised Wound Healing and Gastrointestinal
Perforation: Since Iclusig may compromise wound healing,
interrupt Iclusig for at least 1 week prior to major surgery.
Serious gastrointestinal perforation (fistula) occurred in one
patient 38 days post-cholecystectomy.
Embryo-Fetal Toxicity: Iclusig can cause fetal harm. If
Iclusig is used during pregnancy, or if the patient becomes
pregnant while taking Iclusig, the patient should be apprised of
the potential hazard to the fetus. Advise women to avoid pregnancy
while taking Iclusig.
Most common non-hematologic adverse reactions: (≥20%)
were hypertension, rash, abdominal pain, fatigue, headache, dry
skin, constipation, arthralgia, nausea, and pyrexia. Hematologic
adverse reactions included thrombocytopenia, anemia, neutropenia,
lymphopenia, and leukopenia.
Please see the full U.S. Prescribing Information for
Iclusig, including the Boxed Warning, for additional important
safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts and Lausanne, Switzerland, is an integrated global
oncology company focused on transforming the lives of cancer
patients with breakthrough medicines. ARIAD is working on new
medicines to advance the treatment of various forms of chronic and
acute leukemia, lung cancer and other difficult-to-treat cancers.
ARIAD utilizes computational and structural approaches to design
small-molecule drugs that overcome resistance to existing cancer
medicines. For additional information, visit http://www.ariad.com
or follow ARIAD on Twitter (@ARIADPharm).
ARIAD Pharmaceuticals, Inc.For InvestorsKendra
Adams, 617-503-7028Kendra.adams@ariad.comorFor MediaLiza
Heapes, 617-621-2315Liza.heapes@ariad.com
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