Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3.5 Year Follow-up Data of Imbruvica®▼(ibrutinib)

Today, Janssen-Cilag International NV (“Janssen”) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with Imbruvica^® (ibrutinib). The extended follow-up data demonstrated that patients treated with ibrutinib earlier (at first relapse) experienced the best clinical outcomes, both in terms of efficacy and tolerability. These data (abstract #151) were presented in an oral presentation at the 59^th Annual American Society of Hematology (ASH) Meeting and Exposition in Atlanta, GA.^1,2 Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.

“Data from this large clinical trial data set with extended follow-up support the early use of ibrutinib in patients with relapsed or refractory mantle cell lymphoma,” said Simon Rule, M.D., Professor in Haematology at Plymouth University Medical School, United Kingdom, and lead investigator and presenter of the pooled analysis.* “Long-term follow-up for ibrutinib demonstrates, that in addition to efficacy, new onset adverse events decrease over time and are generally less common when patients are treated earlier.”

MCL is one of several subtypes of B-cell non-Hodgkin lymphoma (NHL) and represents about five to seven percent of malignant lymphoma in Western Europe.³ MCL usually begins with lymph node enlargement and can potentially spread to other tissues such as the bone marrow and liver.⁴ Median overall survival for MCL patients is three to four years.⁵

Abstract #151: Median 3.5-year Follow-Up of Ibrutinib Treatment in Patients with Relapsed/Refractory Mantle Cell Lymphoma: A Pooled Analysis
Oral presentation: Saturday, December 9, 2017, 12:00 PM ET

The pooled analysis includes results from Phase 2 and 3 studies (SPARK, PCYC-1104, and RAY; n=370), and additional follow-up of 87 patients across these studies who enrolled in the long-term open-label extension study, CAN3001. Eighty-three patients were treated with ibrutinib for three or more years, and 40 patients were treated with ibrutinib for four or more years.^1,2 With 3.5 years (41 months) of follow-up, the median progression free survival (PFS) overall was 13 months, and 33.6 (range, 19.4-42.1) months in patients with one prior line of therapy.^1,2 The median PFS in patients achieving complete response (CR) was 46.2 (range, 42.1-not estimable [NE]) months and the duration of response in these patients was 55.7 (range, 55.7-NE) months.¹ Patients with favourable baseline disease characteristics were more likely to remain on ibrutinib for more than three years.² Overall, 53 percent (95 percent confidence interval, 0.47-0.58), 45 percent (0.39-0.50), and 37 percent (0.25-0.49) of patients were alive at two, three, and five years, respectively,² and the median overall survival (OS) was 26.7 months.^1,2

Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 79.7 percent of patients, with the new onset events decreasing after the first year. New onset grade 3/4 TEAEs were generally less common in patients who were treated earlier with ibrutinib.^1,2 In these studies, that permitted enrolment of patients with multiple cardiac risk factors, and among patients experiencing grade 3/4 atrial fibrillation, no patients discontinued treatment and <1 percent had a dose reduction.¹

“We are proud that these results demonstrated the long-term safety and efficacy of ibrutinib after one prior line of therapy in patients with previously treated MCL,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, Middle East and Africa. “As we build on the clinical evidence for ibrutinib, we continue to see sustained benefits in treating B-cell malignancies such as MCL, supporting positive outcomes for such a large patient population in the long-term.”

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.⁶ By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.⁷

Ibrutinib is currently approved in Europe for the following uses:⁸

• As a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL), adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with Waldenström’s Macroglobulinaemia (WM) who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
• As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.

Please see the ibrutinib Summary of Product Characteristics for further information.⁸

About MCL
Mantle Cell Lymphoma (MCL) is considered a rare disease, characterised by high unmet need and small patient populations impacting fewer than one in 200,000 people in Europe and with a median age at diagnosis of 65.^4,9 MCL predominantly affects more men than women and accounts for five to 10 percent of all non-Hodgkin’s lymphomas.^4,10 MCL typically involves the lymph nodes, but can spread to other tissues, such as the bone marrow, liver, spleen and gastrointestinal tract.⁴

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us on www.twitter.com/janssenEMEA for our latest news.

Cilag GmbH International; Janssen Biotech, Inc.; and Janssen-Cilag International NV are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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*Disclaimer: Dr. Rule served as an investigator of this clinical study. Dr. Rule does not have a financial interest in the company.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential of ibrutinib and expectations for its further development. 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 known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

1. Rule S, Dreyling M, Goy A, et al. Median 3.5-year follow-up of ibrutinib treatment in patients with relapsed/refractory mantle cell lymphoma: a pooled analysis. Oral presentation at 59th Annual Meeting and Exposition of the American Society of Hematology, Atlanta, GA, USA, 9-12 December 2017.

2. Rule S, Dreyling M, Goy A, et al. Median 3.5-year follow-up of ibrutinib treatment in patients with relapsed/refractory mantle cell lymphoma: a pooled analysis. Presented at 59th Annual Meeting and Exposition of the American Society of Hematology, Atlanta, GA, USA, 9-12 December 2017; abstract 151.

3. Dreyling M, Campo E, Hermine O, et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(Suppl.4):iv62-iv71.

4. Leukemia and Lymphoma Society. Mantle cell lymphoma facts. Available at: http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/lymphoma/pdf/mantlecelllymphoma.pdf Last accessed December 2017.

5. Herrmann A, Hoster E, Zwingers T, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27:511-8.

6. O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014;15:48-58.

7. European Medicines Agency. EPAR summary for the public: Imbruvica (ibrutinib). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003791/WC500177778.pdf Last accessed December 2017.

8. Imbruvica Summary of Product Characteristics, September 2017. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003791/WC500177775.pdf Last accessed December 2017.

9. Smedby KE, Hjalgrim H. Epidemiology and etiology of mantle cell lymphoma and other non-Hodgkin lymphoma subtypes. Semin Cancer Biol. 2011;21:293-8.

10. Cancer Research UK. Mantle cell lymphoma. Available at: http://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/mantle-cell Last accessed December 2017.

PHEM/IBR/1117/0009
December 2017

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