Landmark Phase III Data Confirms Velcade Significantly Improves Long-Term Overall Survival in Patients With Previously Untreated Multiple Myeloma

TORONTO, March 1, 2013 – Janssen Inc. announced today that five year overall survival data from the landmark Phase III VISTA trial revealed that VELCADE® (bortezomib), administered with melphalan and prednisone, was associated with a median overall survival (OS) benefit of 13.3 months (HR 0.695, p=0.0004) in the treatment of patients with previously untreated multiple myeloma (MM), a form of blood cancer, regardless of subsequent therapy.[i] The data, published in the Journal of Clinical Oncology, shows VELCADE® was also associated with a 31 per cent reduction in the risk of death.1 This data is from the final long-term follow-up analysis of the Phase III VISTA trial, which assessed the overall survival benefit in newly diagnosed patients who were ineligible for transplantation, and treated with bortezomib-melphalan-prednisone (VMP) compared to melphalan-prednisone (MP).

“Improving overall survival is the ultimate goal in treating multiple myeloma,” said Dr. Kevin Song, hematologist and member of the Leukemia/Bone Marrow Transplant Program of British Columbia. “The survival benefit seen in the Phase III VISTA trial is positive as it helped a vast array of patients live significantly longer regardless of subsequent therapy. The trial results further validate the long-term value of bortezomib as an effective treatment option for patients who are living with this incurable disease.”

After five years of follow-up, the data confirmed that median OS in the bortezomib-melphalan-prednisone (VMP group) was nearly five years (56.4 months) compared to 3.6 years (43.1 months) in the melphalan-prednisone (MP) group.1 Time to next treatment (median 27.0 vs. 19.2 months; HR 0.557, p<0.0001) and treatment-free interval (median 16.6 vs. 8.3 months, HR 0.573, p<0.0001) were also superior with VMP vs. MP.1

According to the study results, investigator-assessed response rates to subsequent bortezomib and/or bortezomib-containing regimens were 50 per cent following VMP (i.e., bortezomib re-treatment). In addition, a 58 per cent response rate was observed among patients treated with bortezomib, who were previously treated with MP.1 This data is currently unavailable in the Canadian VELCADE® product monograph.

Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow.[ii] Symptoms of the disease often include bone pain, fatigue, unusual bleeding (usually from the nose and gums), frequent infections and fevers, thirst, weight loss and nausea or vomiting. Multiple myeloma may also cause structural bone damage resulting in painful fractures.[iii] The goal of multiple myeloma treatment is to relieve symptoms, avoid complications, and prolong life.[iv]

“This is welcome news for Canadians living with multiple myeloma,” said Aldo Del Col, Co-Founder and Executive Director of Myeloma Canada. “This data offers real hope to patients for extended life and more time with family and friends.”

About the VISTA Trial1

The VISTA trial is the largest Phase III registration trial to report long-term OS in previously untreated multiple myeloma patients. In this multi-center, international trial, 682 patients with previously untreated multiple myeloma who were not eligible for stem cell transplantation, were enrolled at 151 sites in 22 countries in Europe, North and South America, and Asia. Patients were randomized to receive nine 6-week cycles of bortezomib-melphalan-prednisone (VMP) or melphalan-prednisone (MP) alone. The primary endpoint was time to progression. Secondary endpoints included response rates, overall survival, and safety/tolerability; additional endpoints included time to next therapy and treatment-free interval. Overall, the median age was 71 years with 30 per cent of patients aged 75 and over, and 34 per cent had stage III multiple myeloma. This trial was conducted by Janssen Research & Development, LLC and its co-development partner Millennium Pharmaceuticals, Inc.

About Multiple Myeloma in Canada

Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma.[v] In 2011, there were approximately 7,000 Canadians living with multiple myeloma and the prevalence in Canada continues to rise.[vi] According to the 2012 Canadian Cancer Statistics report released by the Canadian Cancer Society, the total new cases of multiple myeloma diagnosed annually in Canada are estimated at 2,400, with the total number of deaths from multiple myeloma estimated at 1,470 annually.8 The average age at diagnosis is 62 years for men and 61 years for women, and only four per cent of cases are diagnosed in individuals under the age of 45.[vii]

About VELCADE® (bortezomib)[viii]

VELCADE® offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. By blocking the proteasome, VELCADE® disrupts processes related to the growth and survival of cancer cells. The proteasome is a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows.

VELCADE® was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory to their most recent therapy. In September 2008, VELCADE® was approved for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation.

VELCADE® was also approved in June 2008 for the treatment of patients with mantle cell lymphoma (MCL) who have relapsed or are refractory to at least one prior therapy. MCL is a type of non-Hodgkin’s lymphoma, which is a cancer of the blood that affects the white blood cells.

An additional route of administration, subcutaneous injection, was approved for VELCADE® in March 2012. Currently there are limited data concerning retreatment with VELCADE®.

VELCADE® is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

VELCADE® Safety Information7

VELCADE® is approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation and for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have undergone or are unsuitable for stem cell transplantation. VELCADE® is also approved for the treatment of patients with mantle cell lymphoma (MCL), who relapsed or are refractory to at least one prior therapy.

Bortezomib has a predictable safety profile and a favourable benefit-risk ratio. The most common side effects reported with bortezomib include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.1 The subcutaneous administration of bortezomib has fewer side effects and offers greater convenience for patients with similar efficacy compared to intravenous bortezomib.[ix]

VELCADE® must be administered under the supervision of a physician qualified in the use of anti-cancer drugs. VELCADE® is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. VELCADE® should not be administered intrathecally. Fatal events have occurred with intrathecal administration of VELCADE®.

Serious side effects that may occur with VELCADE® include: low blood pressure and other serious heart disorders; bleeding into the brain or gastrointestinal tract (stomach or bowel); muscle weakness due to nerve damage (severe motor neuropathy); and acute lung disease (acute diffuse infiltrative pulmonary disease). Both men and women must use effective contraception while receiving VELCADE®, and for three months after their treatment. Women should be advised not to take VELCADE® while pregnant or breast-feeding.

The safety and effectiveness of VELCADE® in children and adolescents (<18 years of age) have not been established.

These are not all of the possible side effects with VELCADE®. Please refer to the VELCADE® product monograph complete prescribing information including contraindications available at www.janssen.ca.

About Janssen Inc.

As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, immunology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, gastroenterology and women’s health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

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For more information or to arrange an interview, please contact:

Jennifer McCormack Lisa Cancian

Janssen Inc. GCI Group

416-382-5121 416-486-5906

jmccorm3@ITS.JNJ.com lisa.cancian@gcicanada.com

 

Posted: March 2013

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