Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting

ATLANTA, Dec. 11, 2012 /PRNewswire/ -- Janssen Research & Development, LLC, today announced follow-up findings from an ongoing, open-label, Phase 2, single-agent study showing that in patients with relapsed or refractory mantle cell lymphoma (MCL), the investigational oral agent ibrutinib (PCI-32765) resulted in an overall response rate (ORR) of 68 percent, including a complete response (CR) of 22 percent and a partial response (PR) of 46 percent. The study included both bortezomib-naive and bortezomib-exposed patients; 111 received ibrutinib and 110 were evaluable for efficacy. Median follow-up time was 9.2 months, with a range of time to response to treatment of 1.4 to 16.4 months.

The results were presented by lead investigator Michael L. Wang, M.D., associate professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, at the 54th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA. The findings extend the preliminary results reported by the investigators last year at ASH, which showed a similar ORR of 69 percent, including a CR of 16 percent and PR of 53 percent. Results were similar between the bortezomib-naive and bortezomib-exposed patients.

"With continued follow up, the overall response rate is similar to what we've reported before. In addition, the compound has presented a tolerable safety profile,"  said Dr. Wang. "The data build on our knowledge and support the continued study of ibrutinib to determine its potential role as a treatment option for patients with relapsed or refractory MCL, a population that is currently difficult to treat."

Relapsed MCL means the disease has returned after an initial partial or total remission. Refractory MCL refers to cancer that does not respond to current treatment.

Among the study's secondary endpoints, the median progression-free survival (PFS) with ibrutinib was 13.9 months. Additionally, the median time to response to treatment with ibrutinib was 1.9 months for first PR (range of 1.4 to 9.1 months) and 5.5 months for first CR (range of 1.7 to 16.4 months).

Safety data were available for 111 patients in the trial. Patients treated with ibrutinib experienced treatment-emergent adverse events (AEs) that were consistent with previously reported data. Treatment-emergent AEs were mainly grade 1 or 2. Treatment-emergent AEs of all grades occurring in 20 percent or more patients were diarrhea, fatigue, nausea, upper respiratory tract infection and dyspnea (shortness of breath). Pneumonia was the only grade 3 or higher treatment-emergent AE occurring in 5 percent or more patients.

"We are encouraged by the rate and durability of response and the tolerability profile suggested in these Phase 2 study follow-up findings, and look forward to enrolling and seeing results from additional Phase 2 and Phase 3 trials," said Peter Lebowitz, M.D., Ph.D., Global Oncology Therapeutic Area Head, Janssen. "Our collaboration with Pharmacyclics to co-develop ibrutinib in a broad range of B-cell malignancies is part of Janssen's longstanding commitment to apply innovative science to address the most critical unmet needs."

Study Details

PCYC-1104-CA is an international, multicenter, open-label, Phase 2, single-agent study that treated 111 patients (63 bortezomib-naive patients and 48 bortezomib-exposed patients) with relapsed or refractory MCL. Patients were treated with oral ibrutinib 560 mg daily for continuous 28-day cycles until disease progression. The primary endpoint of the study is ORR, and secondary endpoints include duration of response (DOR), PFS, overall survival (OS) and safety/tolerability. The study was conducted by Pharmacyclics.

About Mantle Cell Lymphoma

MCL is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in middle-aged or older adults. The disease typically begins in the lymph nodes but can spread to other tissues, such as bone marrow and liver. In the United States, there are approximately 70,130 new cases of NHL and 4,600 new cases of MCL each year.

About Ibrutinib

Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel – regulating B-cell apoptosis, cell adhesion, and lymphocyte migration and homing. Through these multiple actions, BTK helps to direct malignant B cells to lymphoid tissues, thus allowing access to a microenvironment necessary for survival.

The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, relapsed/refractory mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma. The clinical development program includes 23 clinical trials – six Phase 3, nine Phase 2, one Phase 1/2, and seven Phase 1 trials currently underway.

About the Janssen and Pharmacyclics Collaboration

Janssen Biotech, Inc. and Pharmacyclics Inc. entered into a worldwide collaboration on December 8, 2011, to develop and commercialize ibrutinib. Following regulatory approval, Janssen and Pharmacyclics will co-commercialize ibrutinib. In the United States, both companies will share in commercialization activities; outside the United States, Janssen will lead and perform commercialization activities. Each company is leading development for specific indications.

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com.

Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.  Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology.  Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world.  Follow us on Twitter at www.twitter.com/JanssenUS.

(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 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 January 1, 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.  Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Note: Data in this release correspond to ASH Abstract 904.

SOURCE Janssen Research & Development, LLC

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