Ibrutinib (IMBRUVICA ®) HELIOS Interim Analysis Study Data Show Significant Reductions in Risk of Progression or Death in Patients with Previously-Treated Chronic Lymphocytic Leukemia

Phase 3 data (abstract LBA7005) featured in the official press program of the 51st annual meeting of the American Society of Clinical Oncology

TORONTO, June 3, 2015 /CNW/ - Data from the Phase 3 CLL3001 (HELIOS) trial demonstrated that the combination of ibrutinib (IMBRUVICA®) plus bendamustine and rituximab (BR) reduced the risk of progression or death by 80 per cent and also significantly improved overall response rate (ORR) versus placebo plus BR in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Janssen Research & Development, LLC (Janssen) announced these data at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL and were presented by the lead author of the study, Dr. Asher Chanan-Khan. IMBRUVICA® is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC.

At a pre-planned interim analysis earlier this year, the addition of ibrutinib to BR was shown to significantly improve progression-free survival (PFS; the primary endpoint) and ORR (a key secondary endpoint) compared with the combination of BR and placebo. An independent review committee (IRC) recommended HELIOS be unblinded at that time and patients receiving placebo plus BR be offered the option to receive ibrutinib as their next treatment.

"The HELIOS data are exciting because they show that for previously treated patients where chemo-immunotherapy is considered, the addition of ibrutinib to BR significantly improves progression-free survival compared to chemo-immunotherapy on its own," said Dr. Graeme Fraser, Associate Professor, McMaster University Department of Oncology - Division of Malignant Hematology and Canadian HELIOS trial investigator. "HELIOS demonstrates that ibrutinib added to BR results in favourable outcomes compared to BR alone. Ibrutinib continues to be a strong single-agent treatment option for patients with CLL who have received at least one prior therapy."

HELIOS is a Janssen-sponsored, randomized, double-blind, placebo-controlled, international, multicenter Phase 3 study conducted in 21 countries, which evaluated the safety and efficacy of ibrutinib in combination with BR in 578 patients with relapsed or refractory CLL/SLL who had received at least one prior therapy. Patients were randomized to receive either the combination of 420 mg ibrutinib orally once daily and six cycles of BR, or a matching regimen of placebo orally once daily and six cycles of BR, with ibrutinib or placebo continued until disease progression or unacceptable toxicity. The primary endpoint was IRC-assessed PFS and key secondary endpoints included ORR per IRC, overall survival (OS), rate of minimal residual disease-negative remissions (MRD-negative remissions) and safety.

At a median follow-up of 17 months, IRC-assessed PFS was significantly longer with ibrutinib plus BR, compared to placebo plus BR (median not reached vs. 13.3 months; HR: 0.203, 95 per cent CI: 0.150-0.276, P<0.0001). This difference in PFS rates between study arms was consistent across all subgroups, including those considered high-risk. IRC-assessed PFS rates at 18 months were 79 per cent for patients in the ibrutinib plus BR arm, as compared with 24 per cent for patients in the placebo plus BR arm. The IRC-assessed ORR and complete response/complete response with incomplete marrow recovery (CR/CRi) rates were 82.7 per cent and 10.4 per cent, respectively, for patients taking ibrutinib plus BR versus 67.8 per cent and 2.8 per cent for people in the placebo plus BR arm. The median OS has not yet been reached at a median follow-up of 17 months. Overall, ibrutinib reduced the risk of death by 37 per cent (P=0.06). The OS results are, however, confounded as 90 patients (31 per cent) in the placebo plus BR arm with confirmed progressive disease had crossed over to receive ibrutinib and no longer received placebo for the remainder of the trial. The safety profile of ibrutinib plus BR was consistent with the known individual safety profiles for ibrutinib and BR therapies, respectively. In addition, ibrutinib had no impact on the ability of BR to be administered, with a similar number of BR cycles administered in both study arms.

The most common all-grade adverse events (AEs >20 per cent) in the HELIOS trial were neutropenia (58.2 per cent in the ibrutinib plus BR arm vs. 54.7 per cent in the placebo plus BR arm), nausea (36.9 per cent vs.35.2 per cent), diarrhea (35.5 per cent vs. 23.7 per cent), thrombocytopenia (30.7 per cent vs. 24.4 per cent), pyrexia (24.7 per cent vs. 22 per cent), anemia (22.6 per cent vs. 28.9 per cent) and fatigue (21.6 per cent vs. 22.6 per cent). The most common Grade 3/4 AEs (>15 per cent) were neutropenia (53.7 per cent vs. 50.5 per cent) and thrombocytopenia (15 per cent in both arms). Higher rates of Grade 1/2 bleeding such as hematoma (8 per cent vs. 1 per cent), contusion (7.7 per cent vs. 3.1 per cent), epistaxis (5.9 per cent vs. 3.1 per cent), ecchymosis (3.1 per cent vs. 0.7 per cent) and petechiae (2.8 per cent vs. 0.3 per cent) were observed in patients taking ibrutinib plus BR versus those in the placebo plus BR arm. Rates of major hemorrhage (defined as serious or Grade 3 or greater events) were 3.8 per cent (11 cases) and 1.7 per cent (5 cases), respectively. Few patients had Grade 3/4 atrial fibrillation (8 cases or 2.8 per cent and 2 cases or 0.7 per cent), with most patients having a history of prior atrial fibrillation or cardiac risk factors. Overall, 14.2 per cent of patients in the ibrutinib arm discontinued due to AEs, as compared to 11.8 per cent of patients in the placebo arm. The rates of other malignancies reported during treatment and follow-up were similar in each arm (8.4 per cent in patients taking ibrutinib plus BR vs. 8 per cent in patients taking placebo plus BR).

About IMBRUVICA® (ibrutinib)
IMBRUVICA® is an oral Bruton's tyrosine kinase (BTK) inhibitor that targets and blocks BTK, inhibiting cancer cell survival and spread.1 The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.2,3

IMBRUVICA® is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion. Clinical effectiveness of IMBRUVICA® in the frontline setting is based on the benefit observed in CLL patients with 17p deletion who have received at least one prior therapy. Clinical trial data in the frontline setting are very limited. The combination use of IMBRUVICA® with BR has not been authorized in Canada.

About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia is a blood cancer of white blood cells called lymphocytes, most commonly B cells.4 Chronic lymphocytic leukemia is the most common type of leukemia in adults, with an average age of onset of 65.5 In Canada, it is estimated that about 2,400 adults were diagnosed with CLL in 2010.6 The disease often eventually progresses after treatment, and therefore patients are faced with fewer treatment options and are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.7

About Janssen Inc.
Janssen Inc., Janssen Research & Development, LLC and Janssen Biotech, Inc. are members of the Janssen Pharmaceutical Companies of Johnson & Johnson, which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Please visit www.janssen.ca for more information.

* Dr. Fraser was not compensated for any media work. He has been a paid consultant to Janssen Inc.

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. 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 Inc., Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description 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 28, 2014, including in Exhibit 99 thereto, 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.

1 IMBRUVICA® (Ibrutinib) Product Monograph, Janssen Inc. November 14, 2014.
2 IMBRUVICA® Prescribing Information, January 2015.
3 Genetics Home Reference. Isolated growth hormone deficiency. Available at: http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed May 2015.
4 American Cancer Society. Leukemia--Chronic Lymphocytic. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf. Accessed October 2014.
5 Shaffer AL, Rosenwald A, Staudt LM. "Lymphoid malignancies: the dark side of B-cell differentiation." Nat Rev Immunol 2, no. 12 (2002): 920-32.
6 The Leukemia and Lymphoma Society of Canada. Incidence: How Common Is CLL? Available from: http://www.llscanada.org/#/diseaseinformation/leukemia/chroniclymphocyticleukemia/incidence/. Accessed October 2014.
7 Veliz M, Pinilla-Ibarz J. "Treatment of relapsed or refractory chronic lymphocytic leukemia." Cancer Control. 19, no. 1 (2012): 37-53.

SOURCE Janssen Inc.

For further information: Media Contact: Teresa Pavlin, Office: (416) 382-5017; Investor Contact: Lesley Fishman, Office: (732) 524-3922

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