IMBRUVICA® (ibrutinib) Plus Rituximab Phase 3 iNNOVATE Trial in Rare Waldenström's Macroglobulinemia Met Primary Endpoint

- The iNNOVATE study included newly and previously-treated patients with Waldenström's macroglobulinemia (WM) and will support discussions with regulatory authorities
- The study met its primary endpoint of progression-free survival (PFS) and showed early positive results at the interim analysis stage
- IMBRUVICA is the first and only FDA-approved treatment for newly or previously-treated WM patients, as one of currently eight indications for IMBRUVICA

NORTH CHICAGO, IL, USA I December 5, 2017 I AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA® (ibrutinib) in combination with rituximab in patients with treatment-naïve and previously-treated Waldenström's macroglobulinemia (WM) successfully met its primary endpoint and demonstrated improvement of progression-free survival (PFS) compared to rituximab alone. The Independent Data Monitoring Committee (IDMC) recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

"IMBRUVICA is the first and only treatment approved in Waldenström's macroglobulinemia. We continue to be committed to exploring the full potential of IMBRUVICA, and are pleased to add the results of iNNOVATE to our growing scientific understanding of its use as a combination therapy in WM and other blood cancers," said Thorsten Graef, M.D., Ph.D., Head of Clinical Development at Pharmacyclics LLC, an AbbVie company.

Pharmacyclics and Janssen are planning to share the interim analysis data from the study with regulatory authorities and plan to present the data in a future publication or medical congress. In January 2015, the U.S. FDA granted approval for IMBRUVICA for adult patients with WM. The approval was supported by the FDA's Breakthrough Therapy Designation.

"This is a first-of-its-kind prospective randomized trial in Waldenström's macroglobulinemia," said Meletios A. Dimopoulos, M.D., Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine. "The full report of this study will be of important clinical significance regarding the benefits of the combination of ibrutinib with rituximab in patients with WM."

WM is a rare form of non-Hodgkin's lymphoma, and roughly 1,000 to 1,500 people are diagnosed each year in the U.S.1

About iNNOVATE
iNNOVATE is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which evaluates IMBRUVICA (ibrutinib) in combination with rituximab, and placebo in combination with rituximab in 150 patients with relapsed/refractory and treatment-naïve Waldenström's macroglobulinemia (WM). In the study, patients were randomized to receive intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval. All patients received either ibrutinib 420 mg or placebo once daily continuously until criteria for permanent discontinuation were met. The primary endpoint is progression-free survival, with secondary objectives including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.

About IMBRUVICA
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that mainly works by blocking a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells as well as other serious, debilitating conditions.IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.

IMBRUVICA is FDA-approved in six distinct patient populations: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), along with previously-treated mantle cell lymphoma (MCL), previously-treated marginal zone lymphoma (MZL) and previously-treated chronic graft-versus-host disease (cGVHD).3

  • IMBRUVICA was first approved for adult patients with MCL who have received at least one prior therapy in November 2013.
  • Soon after, IMBRUVICA was initially approved in adult CLL patients who have received at least one prior therapy in February 2014. By July 2014, the therapy received approval for adult CLL patients with 17p deletion, and by March 2016, the therapy was approved as a frontline CLL treatment.
  • IMBRUVICA was approved for adult patients with WM in January 2015.
  • In May 2016, IMBRUVICA was approved in combination with bendamustine and rituximab (BR) for adult patients with previously-treated CLL/SLL.
  • In January 2017, IMBRUVICA was approved for adult patients with MZL who require systemic therapy and have received at least one prior anti-CD20-based therapy.
  • In August 2017, IMBRUVICA was approved for adult patients with cGVHD that failed to respond to one or more lines of systemic therapy.

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

IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.4 IMBRUVICA was one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. Worldwide, IMBRUVICA was used to treat more than 90,000 patients to date.

About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

1 American Cancer Society. What Is Waldenstrom Macroglobulinemia? Available from: https://www.cancer.org/cancer/waldenstrom-macroglobulinemia/about/what-is-wm.html. Accessed December 2017.

2 Genetics Home Reference. Isolated growth hormone deficiency. Available from: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed December 2017.

3 IMBRUVICA U.S. Prescribing Information, August 2017.

4 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. Available from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed December 2017.

SOURCE: AbbVie

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