CHICAGO - Companies of Johnson & Johnson announced primary results from the Phase 3 SHINE study (Abstract #7502), which demonstrated that the combination of once-daily oral IMBRUVICA (ibrutinib) plus bendamustine-rituximab (BR) and rituximab maintenance significantly reduced the risk of disease progression or death by 25 percent compared to patients who received placebo plus BR and rituximab maintenance in patients aged 65 years or older with newly diagnosed mantle cell lymphoma (MCL).[i] This study is one of the largest clinical trials ever conducted in first-line MCL and the first for a Bruton's tyrosine kinase inhibitor (BTKi).1 The data are being presented in an oral session and featured in a press briefing during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine today. The data will also be presented as an oral presentation at the 2022 European Hematology Association (EHA) Annual Congress.

MCL is a type of aggressive, rare non-Hodgkin lymphoma (NHL) that is incurable and difficult to treat.[i] It commonly affects people over the age of 65, who typically cannot tolerate intensive chemoimmunotherapy and stem cell transplantation, resulting in poor clinical outcomes and contributing to the need to develop additional treatment options for these patients.2

'There is an urgent need to improve outcomes for older patients with MCL,' said Michael L. Wang, M.D., Professor, Department of Lymphoma & Myeloma, The University of Texas MD Anderson Cancer Center and principal study investigator.(++) 'Given the median progression-free survival of 6.7 years, the ibrutinib combination demonstrated the potential to be a first-line treatment in this population.'

The Phase 3 SHINE (MCL3002) study (NCT01776840) - sponsored by Janssen Biotech, Inc., in collaboration with Pharmacyclics LLC, an AbbVie Company - enrolled 523 patients aged 65 years or older with newly diagnosed MCL.1 All participants were randomly assigned to receive IMBRUVICA (560 mg orally daily until progression or unacceptable toxicities) or placebo plus BR for a maximum of six 28-day cycles; participants with a complete response (CR) or partial response (PR) continued to receive maintenance therapy with rituximab every second cycle for a maximum of 12 additional doses.1IMBRUVICA or placebo was administered daily until progressive disease or unacceptable toxicity.1

The SHINE study met its primary endpoint of progression-free survival (PFS). Key findings from the Phase 3 SHINE study include:

With a median follow-up of 84.7 months, the IMBRUVICA plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS (6.7 years) vs. BR (4.4 years).1 This is a 50 percent improvement as compared to patients treated with BR and rituximab maintenance (stratified hazard ratio [HR]: 0.75, 95 percent confidence interval [CI], 0.59-0.96; p = 0.011).1

Key secondary endpoints included: CR, time-to-next treatment (TTNT), overall survival (OS), and overall response rate (ORR).1

A CR was achieved in 171 patients (65.5 percent) in the IMBRUVICA plus BR arm and 151 patients (57.6 percent) in the placebo arm (p = 0.057).1 The rates of objective response were similar between the two arms (IMBRUVICA plus BR: 89.7 percent; placebo: 88.5 percent).1

Median TTNT was not reached in the IMBRUVICA plus BR arm, the median TTNT was 92 months in the placebo plus BR arm (p < 0.001).1

OS was similar between treatment arms and median OS was not reached in either treatment arm (p = 0.06).1,3

'More than eight years since its first FDA approval, IMBRUVICA has treated over 250,000 patients globally, fundamentally changing the treatment paradigm for complex B-cell malignancies,' said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. 'The Phase 3 SHINE study reinforces our continued commitment to the development of IMBRUVICA to provide meaningful differences and change outcomes for patients with B-cell malignancies where high unmet medical needs still remain.'

The safety profile of the IMBRUVICA plus BR regimen was consistent with known safety profiles of IMBRUVICA as well as BR.1 Across all treated patients, the most common Grade 3/4 Adverse Events (AEs) ?5 percent were neutropenia (IMBRUVICA plus BR: 47.1 percent; BR: 48.1 percent), pneumonia (IMBRUVICA plus BR: 20.1 percent; BR:14.2 percent), anemia (IMBRUVICA plus BR: 15.4 percent; BR: 8.8 percent), thrombocytopenia (IMBRUVICA plus BR: 12.7 percent; BR: 13.1 percent), rash (IMBRUVICA plus BR: 12 percent; BR: 1.9 percent), and diarrhea (IMBRUVICA plus BR: 6.9 percent; BR: 3.8 percent).1 Treatment-emergent AEs of clinical interest with BTKis included atrial fibrillation (AF) which was reported in 13.9 percent of patients in the IMBRUVICA plus BR arm and 6.5 percent in the placebo arm; hypertension in 13.5 percent and 11.2 percent; major bleeding in 5.8 percent and 4.2 percent; any bleeding 42.9 percent and 21.5 percent; and arthralgia in 17.4 percent and 16.9 percent, respectively.1

IMBRUVICA is currently approved globally for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.4 Within the U.S., this indication is approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

About IMBRUVICA

IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. IMBRUVICA blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments and inhibits their proliferation.5,6,7

IMBRUVICA is approved in more than 100 countries for at least one indication and has been used to treat more than 250,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, with over 11 years evaluating the efficacy and safety of IMBRUVICA.

IMBRUVICA was first approved by the U.S. Food and Drug Administration (FDA) in November 2013, and today is indicated for adult patients in six disease areas, including five hematologic cancers. These include indications to treat adults with CLL/SLL with or without 17p deletion (del17p), and adults with Waldenstrom's macroglobulinemia (WM), and adult patients with previously treated mantle cell lymphoma (MCL)*, as well as to treat adult patients with previously treated marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy(+), and adult patients with previously treated chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.4

Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

The National Comprehensive Cancer Network (NCCN), recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and has Category 1 treatment status for treatment-naive patients without deletion 17p/TP53 mutation and as a preferred treatment for treatment-naive patients with deletion 17p/TP53 mutation. The NCCN Guidelines also recommend IMBRUVICA, with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, as a Category 1 preferred regimen for both untreated and previously treated WM patients, and as a preferred regimen for relapsed/refractory MZL.7

Cautions Concerning Forward-Looking Statements

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMBRUVICA (ibrutinib). 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 Research & Development, LLC or 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 2, 2022, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Contact:

Media

Christie Corbett

T: +1 857-636-0211

(C) 2022 Electronic News Publishing, source ENP Newswire