Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA ® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukaemia

New data from the Phase 2 CAPTIVATE study (PCYC-1142) were presented today during an oral session at the 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123).¹ The study evaluated the efficacy and safety of IMBRUVICA^® (ibrutinib) plus venetoclax in the treatment of adult patients with chronic lymphocytic leukaemia (CLL) and showed that, after achieving undetectable minimal residual disease (uMRD) in both the blood and bone marrow with the ibrutinib combination regimen, the one-year disease-free survival (DFS) of patients randomised to discontinue active treatment was comparable to that of patients randomised to continue ibrutinib monotherapy (95.3 percent vs. 100 percent, respectively [p=0.1475]).¹

“These data demonstrate the potential of this oral, once-daily, chemotherapy-free combination regimen in first-line treatment of CLL,” said William Wierda,* M.D., Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal study investigator. “Once-daily treatment with ibrutinib remains the established standard of care in CLL; the latest results from the CAPTIVATE study underscore that the mechanistic synergy of ibrutinib and venetoclax delivers deep MRD remissions in the blood and bone marrow and enables treatment-free periods for patients.”

The CAPTIVATE trial is evaluating adult patients younger than 70 years, including patients with high-risk disease, in two cohorts: an MRD Guided Cohort where treatment duration is guided by the patient’s MRD status after 12 cycles of combination ibrutinib plus venetoclax therapy; and a Fixed Duration Cohort where all patients stop therapy after 12 cycles of the combination, regardless of MRD status. Patients in the MRD Guided Cohort (n=164; median age, 58 years) who achieved uMRD, defined as having uMRD (<10^–4 by 8-color flow cytometry) serially over at least three cycles and undetectable MRD in both peripheral blood (PB) and bone marrow (BM) with combination therapy, were randomised in a double-blinded fashion to continue treatment with ibrutinib monotherapy or placebo until disease progression.¹

Patients in the MRD Guided Cohort who did not achieve uMRD following 12 cycles of combination ibrutinib plus venetoclax therapy were randomised to continue ibrutinib monotherapy or the combination.¹ With a median total treatment duration of 28.6 months (range, 0.5-39.8) with ibrutinib and 12.0 months (range, 0.8-34.1) with venetoclax, increases in uMRD rates were greater with continued combination therapy versus continued ibrutinib monotherapy.^1,2 Across all four randomised arms, 30-month progression-free survival rates were 95 percent or greater.^1,2

The safety profile of the ibrutinib plus venetoclax regimen was consistent with known safety profiles of the individual therapies.¹ Across all treated patients, the most common grade 3/4 adverse events (AEs) were neutropenia (36 percent), hypertension (10 percent), thrombocytopenia (5 percent), and diarrhoea (5 percent).¹

“Ibrutinib is the only Bruton’s tyrosine kinase inhibitor that has shown significant overall survival and progression-free survival benefits in randomised Phase 3 studies in first-line CLL, and it continues to demonstrate efficacy and safety across regimens and patient subgroups, including those with historically poor outcomes,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “Results from the randomised phase of the MRD Guided Cohort of the CAPTIVATE study show that treatment-free remissions are possible with ibrutinib-based fixed duration therapy, providing yet another treatment option for patients starting first-line CLL treatment.”

“Ibrutinib has impacted more than 200,000 patients worldwide and the CAPTIVATE study provides more evidence in support of the lasting effect that can be achieved in people living with CLL over time,” adds Dr Catherine Taylor, Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Janssen-Cilag Ltd., Middle East. “The manageable safety profile of the ibrutinib combination with a low rate of discontinuation underscores this regimen as a potential viable option and we are excited to explore how it can benefit patients in a front-line setting.”

The registrational Phase 3 GLOW study, assessing ibrutinib plus venetoclax in comparison to chlorambucil plus obinutuzumab for first-line treatment of elderly or younger unfit patients with CLL (NCT03462719) is ongoing as part of the comprehensive development programme exploring the potential of ibrutinib-based fixed duration therapy.³

*William Wierda is the lead investigator of the CAPTIVATE study. He was not compensated for any media work.

#ENDS#

About Ibrutinib
Ibrutinib is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.⁴ Ibrutinib blocks the BTK protein; the BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signalling is needed by specific cancer cells to multiply and spread.⁵ By blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.⁶

Indications for which ibrutinib is approved in Europe include:³

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

Ibrutinib is approved in more than 100 countries for at least one indication, and to date, has been used to treat more than 200,000 patients worldwide.⁷

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.⁸ The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.⁹ CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.¹⁰

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA for our latest news. Janssen-Cilag Ltd., Middle East and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 materialise, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica NV and/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 behaviour 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 December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

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¹ Weirda W.G. et al. Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study. 2020 American Society of Hematology Annual Meeting. Oral Presentation. December 2020.
² Weirda W.G. et al. Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study. 2020 American Society of Hematology Annual Meeting. Abstract #123.
³ ClinicalTrials.gov. A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). Available at: https://clinicaltrials.gov/ct2/show/NCT03462719 Last accessed December 2020.
⁴ Imbruvica Summary of Product Characteristics, January 2020. Available at: https://www.ema.europa.eu/documents/product-information/imbruvica-epar-product-information_en.pdf Last accessed December 2020.
⁵ Turetsky, A, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014).
⁶ de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.
⁷ Janssen Data on File (EMEA-SR-1492). Global number of cumulative patients treated with Ibrutinib since launch. July 2020.
⁸ American Cancer Society. What is chronic lymphocytic leukemia? Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html Last accessed December 2020.
⁹ Sant M, Allemani C, Tereanu C, et al. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood. 2010;116:3724–34.
¹⁰ Eichhorst B, Robak T, Montserrat E, et al. Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl.5):v78-v84.

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December 2020

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