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TMCNet:  ARIAD Announces Data Presentations and Webcast of Investor Briefing at the 2014 ASCO Annual Meeting

[May 14, 2014]

ARIAD Announces Data Presentations and Webcast of Investor Briefing at the 2014 ASCO Annual Meeting

CAMBRIDGE, Mass. --(Business Wire)--

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that clinical data on Iclusig® (ponatinib) and AP26113, its investigational oral inhibitor of anaplastic lymphoma kinase (ALK), will be presented at the Annual Meeting of the American Society of Clinical Oncology being held in Chicago, May 30 to June 3, 2014.

The schedule and meeting location for the sessions, together with the abstract information, and details on the Company's investor briefing are listed below:

Ponatinib




Title:                  

A Phase 2 Study of Ponatinib in Patients with Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Tyrosine Kinase Inhibitor (TKI) Therapy: Initial Report

Abstract No: 10506
Presenter: Michael C. Heinrich, M.D., (Knight Cancer Institute, Oregon Health & Science University and Portland VA Medical Center)
Oral Session: Sarcoma
Date & Time: Sunday, June 1, 2014, 8:00 a.m. to 11:00 a.m. (CT)
Location: S406
       

Title:

EPIC: A Phase 3 Trial of Ponatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CP-CML)

Abstract No: 7023
Presenter: Jeffrey H. Lipton, M.D., Ph.D., (Ontario Cancer Institute, Princess Margaret Hospital)
Poster Session: Leukemia, Myelodysplasia, and Transplantation
Date & Time: Saturday, May 31, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Poster Discussion: 4:45 p.m. to 6:00 p.m. in S405, S406
Location: S405
             
Title:

Clinical Impact of Dose Modification and Dose Intensity on Response to Ponatinib in Patients with Philadelphia Chromosome-Positive Leukemias

Abstract No: 7084
Presenter: Andreas Hochhaus, M.D., (University Medical Center Jena, Germany)
Poster Session: Leukemia, Myelodysplasia, and Transplantation
Date & Time: Monday, June 2, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Location: S Hall A2
               
Title:

Ponatinib in Patients with Philadelphia Chromosome-Positive Leukemias Resistant or Intolerant to Dasatinib or Nilotinib, or with the T315I Mutation: Longer-Term Follow-Up of the PACE Trial

Abstract No: 7081
Presenter: Hagop M. Kantarjian, M.D., (The University of Texas MD Anderson Cancer Center)
Poster Session: Leukemia, Myelodysplasia, and Transplantation
Date & Time: Monday, June 2, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Location: S Hall A2
           
Title:

Long Term Follow-Up of a Phase 1 Study of Ponatinib in Patients with Philadelphia Chromosome Positive Leukemias

Abstract No: 7078
Presenter: Moshe Talpaz, M.D., (University of Michigan Comprehensive Cancer Center)
Poster Session: Leukemia, Myelodysplasia, and Transplantation
Date & Time: Monday, June 2, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Location: S Hall A2
           
Title:

Economic Burden of Tyrosine Kinase Inhibitor (TKI) Treatment Failure in Patients with Chronic Myeloid Leukemia

Abstract No: 7091
Presenter: Yaozhu J. Chen, MPA, (IMS Health)
Poster Session: Leukemia, Myelodysplasia, and Transplantation
Date & Time: Monday, June 2, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Location: S Hall A2
 
 

AP26113

         
 
Title:

Updated Efficacy and Safety of the ALK Inhibitor AP26113 in Patients with Advanced Malignancies, Including ALK+ Non-Small Cell Lung Cancer (NSCLC)

Abstract No: 8047
Presenter: Scott N. Gettinger, M.D., (Yale Cancer Center)
Poster Session: Lung Cancer - Non-Small Cell Metastatic
Date & Time: Saturday, May 31, 2014, 1:15 p.m. to 5:00 p.m. (CT)
Location: S Hall A2
 
 

Investor and Analyst Briefing and Webcast

A breakfast meeting featuring key investigators who will review the most recent clinical data from Iclusig and AP26113 will be webcast live along with slides and can be accessed by visiting the investor relations section of the Company's website at http://investor.ariad.com.

Date:   Monday, June 2, 2014
Time: 7:30 a.m. to 8:30 a.m. (CT)
Location: Chicago Hilton, Marquette Room

Space is limited. To request attendance at the meeting, please RSVP to Investor.RSVP@ariad.com by Tuesday, May 27, 2014.

A replay of the investor event will be available on the ARIAD website approximately three hours after the presentation and will be archived on the site for four weeks. To ensure a timely connection to the live webcast, participants should log onto the webcast at least 15 minutes prior to the scheduled start time.

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 least27% 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 (News - Alert) (@ARIADPharm).

Iclusig® is a registered trademark of ARIAD Pharmaceuticals, Inc.


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