PHARMACYCLICS, INC. - Results show statistically significant improvements in both progression-free survival and key secondary endpoints including overall survival
SUNNYVALE, CA, June 4, 2015 - Today, Pharmacyclics LLC, an AbbVie company, announced that ibrutinib (IMBRUVICA®) improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL, respectively) in the final analysis of the Phase III RESONATETM-2 (PCYC- 1115) trial. RESONATE-2 is a randomized, multi-center, open-label study assessing the use of ibrutinib versus chlorambucil in treatment-naïve CLL/SLL patients aged 65 years or older. This is the first head-to-head trial in the clinical program that evaluates the safety and efficacy of ibrutinib versus traditional chemotherapy. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.
"In collaboration with our partner Janssen, we are very excited by the findings from RESONATE-2 and look forward to sharing the results from what we see as a potentially transformative study for CLL patients," said Danelle James, M.D., M.S., Head of Oncology at Pharmacyclics. "These results from the first IMBRUVICA study for front-line CLL patients may support future treatment paradigms where some CLL patients requiring therapy, may not need to be exposed to traditional cytotoxic chemotherapy."
"Over the past several years we've made tremendous progress in treating CLL, thanks in part to therapies such as IMBRUVICA," said Richard A. Gonzalez, Chairman of the Board and Chief Executive Officer at AbbVie. "Based on the results from RESONATE-2, IMBRUVICA continues to demonstrate its strong value and we are very optimistic that it will eventually move into the
front-line treatment setting, becoming an alternative option to chemotherapy for previously untreated CLL patients."
RESONATE-2 is a Pharmacyclics-sponsored trial and its protocol and specific performance goals were established in a special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). A SPA is an agreement with the FDA that an ongoing Phase III clinical trial design, its clinical endpoints, and other statistical analyses are acceptable to the Agency to support an approval. The trial enrolled 269 patients with CLL/SLL aged 65 years or older without prior treatment in the U.S., EU and other regions. CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL) were excluded from the trial since single-agent chlorambucil is not an effective therapy in this population. Patients were randomized to receive either ibrutinib 420 mg orally, once daily until progression or toxicity or chlorambucil on days 1 and 15 of each 28-day cycle for up to 12 cycles. The starting dose for chlorambucil in Cycle 1 was 0.5 mg/kg and was increased based on tolerability in Cycle 2 by increments of 0.1 mg/kg to a maximum of
0.8 mg/kg. The primary endpoint of the study was PFS as assessed by an Independent Review Committee according to the International Workshop on Chronic Lymphocytic Leukemia (iWCLL) 2008 criteria, with modification for treatment-related lymphocytosis. Key secondary endpoints included ORR, OS, and safety.
The data will be submitted for presentation at an upcoming medical conference and for full publication in a peer-reviewed journal. A full study report is being prepared and will be submitted to health authorities for future labeling considerations. More information about the study can be found on www.clinicaltrials.gov.
IMBRUVICA is currently approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, all CLL patients (including treatment-naive) who have del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost, and all patients (including treatment-naive) with Waldenström's macroglobulinemia.1 IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.1
IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).1 IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.
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.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1
IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers. More than 6,100 patients have been treated in clinical trials of IMBRUVICA conducted in 35 countries by more than 800 investigators. Currently, 13 Phase III trials have been initiated with IMBRUVICA and 67 trials are registered on www.clinicaltrials.gov.
To learn more about the medical terminology used in this news release, please visit http://stedmansonline.com/.
Warnings and precautions include hemorrhage, infections, cytopenias, atrial fibrillation, second primary malignancies, Tumor Lysis Syndrome and embryo-fetal toxicity.
The most common adverse reactions (≥25%) in patients with B-cell malignancies (MCL, CLL, WM) were thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, bruising, nausea, upper respiratory tract infection, and rash. For additional important safety information, please see Important Safety Information and the full Prescribing Information at www.imbruvica.com/downloads/Prescribing_Information.pdf.
Pharmacyclics, a wholly-owned subsidiary of AbbVie (NYSE: ABBV), is focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune- mediated diseases. Pharmacyclics' mission is to develop and commercialize novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical needs.
Pharmacyclics markets IMBRUVICA and has three product candidates in clinical development and several preclinical molecules in lead optimization. Pharmacyclics is committed to high standards of ethics, scientific rigor and operational efficiency as it moves each of these programs toward commercialization. To learn more, please visit www.pharmacyclics.com.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, the likelihood that the transaction is consummated, the expected benefits of the transaction, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward- looking statements as a result of subsequent events or developments, except as required by law.
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IMBRUVICA is a registered trademark of Pharmacyclics LLC SOURCE Pharmacyclics LLC
1 IMBRUVICA Prescribing Information, January 2015
2 Genetics Home Reference. Isolated growth hormone deficiency. Available at: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed June 2015.
Pharmacyclics Inc. issued this content on 2016-01-07 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 2016-01-07 20:35:04 UTC
Original Document: http://www.pharmacyclics.com/docs/librariesprovider4/press-releases/2015/10_pcyc-resonate-2-top-line-release-6-4-15.pdf?sfvrsn=6
