Janssen Oncology Data to be Presented at 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, Including ZYTIGA®, Ibrutinib and Daratumumab Data Note: This release corresponds to ASCO abstracts 5014, 5004, 5009, 5010, 5013, 5037, 5059, 9617, 9618, 5059, 8502, 7130, 8619, 8613, 8614, 7014, 7056, 7057, 8512 and electronic publication e17510

RARITAN, N.J., May 15, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced that data related to three Janssen Oncology compounds have been selected for presentation at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 31-June 4, 2013 in Chicago, IL. Fourteen abstracts for ZYTIGA® (abiraterone acetate), ibrutinib, the investigational Bruton's tyrosine kinase (BTK) inhibitor, and daratumumab, an investigational human CD38 monoclonal antibody, will be presented. An additional six abstracts were also accepted as publication-only or in the trial in progress category. Eight ibrutinib data presentations were jointly sponsored by Janssen and Pharmacyclics, Inc.; 11 ZYTIGA® studies were sponsored by Janssen and one daratumumab data presentation was jointly sponsored by Janssen and Genmab.

"We are looking forward to presentations at ASCO which highlight important clinical data from three of our oncology compounds," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen. "Our portfolio is robust and growing.  We look forward to additional compounds coming through the pipeline."

The following ZYTIGA® clinical study data have been selected for presentation:

  • Effect of corticosteroid (CS) use at baseline (CUB) on overall survival (OS) in patients (pts) receiving abiraterone acetate (AA): Results from a randomized study (COU-AA-301) in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel (D). (Abstract 5014)
    Oral abstract session: Genitourinary Cancer, Sunday, June 2, 8:45am-9:00am CDT., E Hall D2  Lead Author: Robert B. Montgomery, MD, University of Washington, Seattle, WA, USA
  • ERG rearrangements and association with clinical outcome in patients (pts) receiving abiraterone acetate (AA): Results from the COU-AA-302 study in chemotherapy (chemo)-naive metastatic castration-resistant prostate cancer (mCRPC). (Abstract 5004) 
    Oral abstract session: Genitourinary Cancer, Sunday, June 2, 9:15am-9:30am CDT., E Hall D2  Lead Author: Gerhardt Attard, MD, Ph.D., The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK
  • Long-term safety and efficacy analysis of abiraterone acetate (AA) plus prednisone (P) in metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy (COU-AA-302). (Abstract 5009)Poster discussion session (display): Genitourinary Cancer (Poster board 1), Saturday, June 1, 8:00am-12:00pm CDT., E450a Lead Author: Dana E. Rathkopf, MD, Memorial Sloan-Kettering Cancer Center, NY, USA
  • Relationship of baseline PSA and degree of PSA decline to radiographic progression-free survival (rPFS) in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC): Results from COU-AA-302. (Abstract 5010)                                                   
    Poster discussion session (display): Genitourinary Cancer (Poster board 2), Saturday, June 1, 8:00am-12:00pm CDT., E450a Lead Author: Charles J. Ryan, MD, Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, CA, USA
  • A prognostic model for predicting overall survival (OS) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA) after docetaxel. (Abstract 5013)
    Poster discussion session (display): Genitourinary Cancer (Poster board 5), Saturday, June 1, 8:00am-12:00pm CDT., E450a Lead Author: Kim N. Chi, MD, BC Cancer Agency, Vancouver, BC, Canada
  • Impact of concomitant bone-targeted therapies (BTT) on outcomes in metastatic castration-resistant prostate cancer (mCRPC) patients (pts) without prior chemotherapy (ctx) treated with abiraterone acetate (AA) or prednisone (P). (Abstract 5037)
    General poster session: Genitourinary Cancer, Monday, June 3, 8:00am-11:45am CDT., S Hall A2 Lead Author: Fred Saad, MD, University of Montreal Hospital Center, CRCHUM, Montreal, QC, Canada
  • Interim safety results of a global early access protocol (EAP) of abiraterone acetate (AA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) progressing after taxane-based chemotherapy. (Abstract 5059)
    General poster session: Genitourinary Cancer, Monday, June 3, 8:00am-11:45am CDT., S Hall A2 Lead Author, Daniel J. George, MD, Duke Cancer Institute, Durham, NC, USA
  • Randomized double-blind, comparative study of abiraterone acetate (AA) plus low-dose prednisone (P) plus androgen deprivation therapy (ADT) versus ADT alone in newly diagnosed, high-risk, metastatic hormone-naive prostate cancer (mHNPC). (Abstract TPS5097)
    Trial in progress poster. General poster session: Genitourinary Cancer, Monday, June 3, 8:00am-11:45am CDT., S Hall A2 Lead Author: Karim Fizazi, MD, Ph.D., Institut Gustave Roussy, University of Paris Sud, Villejuif, France
  • Is there an additional health-related quality of life (HRQL) benefit with abiraterone acetate (AA) in metastatic castration-resistant prostate cancer (mCRPC) beyond that mediated by clinical endpoints? (Abstract 9617)
    General poster session: Patient and Survivor Care, Monday, June 3, 1:15pm-5:00pm CDT., S Hall A2 Lead Author: David Cella, Ph.D., Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA
  • Effect of abiraterone acetate (AA) on patient-reported pain in metastatic castration-resistant prostate cancer (mCRPC) post-docetaxel: Results of longitudinal sensitivity analyses. (Abstract 9618)
    General Poster Session: Patient and Survivor Care, Monday, June 3, 1:15pm-5:00pm CDT., S Hall A2 Lead Author: Yanni Hao, Ph.D., Janssen Global Services, Raritan, NJ, USA
  • Identification, characterization, and chemotherapy utilization in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) using real world data: Retrospective US claims database           
    Electronic publication e17510, available on www.asco.org and www.jco.org          
    Lead Author: Thomas W. Flaig, MD, University of Colorado Cancer Center, Aurora, CO, USA

The following ibrutinib clinical study data have been selected for presentation:

  • Phase 1b study combining ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in patients with CD20-positive B-cell non-Hodgkin's lymphoma (NHL).  (Abstract 8502)
    Oral presentation. Oral abstract session: Lymphoma and plasma cell disorders, Saturday, June 1, at 1:45pm-2:00pm CDT., E354a Lead Author: Anas Younes, MD, The University of Texas, MD Anderson Cancer Center, Houston, TX, USA
  • Randomized, multicenter, open-label, phase 3 study of the BTK inhibitor ibrutinib versus chlorambucil in patients 65 years or older with treatment-naive CLL or SLL (RESONATE -2, PCYC-1115-CA). (Abstract TPS7130)   
    Trial in progress poster. General poster session: Leukemia, myelodysplasia and transplantation, Sunday, June 2, 8:00am-11:45am CDT., S Hall A2  Lead Author: Jan A. Burger, MD, Ph.D., The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  • A randomized, multicenter, open-label, phase 3 study of the Bruton's tyrosine kinase (btk) inhibitor ibrutinib (PCI-32765) versus ofatumumab in patients (pts) with relapsed or refractory (RR) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL): RESONATE™. (Abstract TPS8619)
    Trial in progress poster. General poster session: Lymphoma and plasma cell disorders, Sunday, June 2, 8:00am-11.45am CDT., S Hall A2
    Lead Author: Jan A. Burger, MD, Ph.D., Ohio State University, Columbus, OH, USA
  • A phase 3 study of ibrutinib in combination with bendamustine and rituximab (BR) in elderly patients with newly diagnosed mantle cell lymphoma (MCL). (Abstract TPS8613)                         
    Trial in progress poster. General poster session: Lymphoma and plasma cell disorders, Sunday, June 2, 8:00am-11:45am CDT.,  Lead Author: Michael Wang, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
  • An open-label phase 2 study of ibrutinib in patients with refractory follicular lymphoma (Abstract TPS8614)                                                                                                                               Trial in progress poster. General poster session: Lymphoma and plasma cell disorders, Sunday, June 2, 8:00am - 11:45am CDT., S Hall A2
     Lead Author: Gilles A. Salles, MD, Central Hospitalier Lyon-Sud, France
  • Use of tumor genomic profiling to reveal mechanisms of resistance to the BTK inhibitor ibrutinib in chronic lymphocytic leukemia (CLL). (Abstract 7014) 
    Poster discussion session (display): Leukemia, myelodysplasia, and transplantation (Poster board 6), Saturday, June 1, 8:00am-12:00pm CDT., S405   
    Lead Author: Betty Y. Chang, Ph.D., Pharmacyclics Inc., Sunnyvale, CA, USA
  • Pharmacokinetics (PK) of ibrutinib in patients with chronic lymphocytic leukemia (CLL). (Abstract 7056) General poster session: Leukemia, myelodysplasia and transplantation, Sunday, June 2, 8:00am-11:45am CDT., S Hall A2                            
    Lead Author: Juthamas Sukbuntherng, Ph.D., Pharmacyclics, Sunnyvale, CA, USA
  • Open label evaluation of ECG in patients with chronic lymphocytic leukemia (CLL) receiving ibrutinib monotherapy. (Abstract 7057) General poster session: Leukemia, myelodysplasia and transplantation, Sunday, June 2, 8:00am-11:45am CDT., S Hall A2                                                      
    Lead Author: David Loury, Ph.D., DABT, Pharmacyclics, Sunnyvale, CA, USA

The following daratumumab clinical study data has been selected for presentation:

  • Phase 1/2 dose-escalation study of daratumumab in patients with relapsed or refractory multiple myeloma. (Abstract 8512)Oral Abstract Session: Lymphoma and plasma cell disorders, Monday, June 3, 9:00am-9:15am CDT., E Arie Crown Theater Lead Author: Henk M. Lokhorst, MD, University Medical Center Utrecht, The Netherlands

About ZYTIGA®

ZYTIGA® (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

Since its first approval in the U.S. in 2011, ZYTIGA® has been approved in more than 75 countries. More than 60,000 men worldwide have received treatment with ZYTIGA, and it is quickly becoming one of the cornerstones of treatments for mCRPC.

More information about ZYTIGA® can be found at www.zytiga.com.

Important safety information

Contraindications - ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess - Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) - AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity - Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient's baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food - ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC from zero to infinity (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions - The most common adverse reactions (greater than or equal to 10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions - ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®.

Use in Specific Populations - Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

About ibrutinib

Ibrutinib is an investigational, oral Bruton's tyrosine kinase (BTK) inhibitor. The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies.

Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize ibrutinib. The regulatory filing for ibrutinib in MCL is expected to be made prior to the end of the third quarter of 2013.

To date, ibrutinib has been granted three Breakthrough Therapy Designations by the U.S. Food & Drug Administration (FDA) as a monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with deletion of the short arm of chromosome 17 (del17p); patients with relapsed or refractory mantle cell lymphoma (MCL) who have received prior therapy, and in patients with Waldenstrom's macroglobulinemia (WM). The implications of Breakthrough Therapy Designation cannot be determined at this time.

About daratumumab

Daratumumab is an investigational human monoclonal antibody (mAb) with broad spectrum cytotoxic activity. It targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab. In May 2013, daratumumab was granted Breakthrough Therapy Designation by the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development and Janssen Biotech are part of the Janssen Pharmaceutical Companies. Please visit http://www.janssenrnd.com for more information.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

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SOURCE Janssen Research & Development, LLC



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