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Millennium: The Takeda Oncology Company Reports Positive Velcade Trial Data


12/10/2012 7:35:02 AM

ATLANTA--(BUSINESS WIRE)-- Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced results from two studies evaluating the safety and efficacy of VELCADE-based therapy. The first study reported data from a meta-analysis of VELCADE retreatment in patients with relapsed and/or refractory (R/R) multiple myeloma (MM). The second study (GIMEMA) evaluated VELCADE in combination with thalidomide as maintenance therapy for patients with previously untreated MM. These data were presented at the 54th American Society of Hematology (ASH) Annual Meeting held December 8-11, 2012 in Atlanta, GA.

“In this meta-analysis of more than 1,000 patients, a remarkable 39 percent response rate was achieved with VELCADE-based retreatment in patients with relapsed or refractory multiple myeloma,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “The GIMEMA study continues to affirm the known overall survival benefit of VELCADE-based therapy in patients with previously untreated multiple myeloma.”

“The GIMEMA study is the first phase 3 study to demonstrate that VELCADE-based maintenance reduces the risk of death by 30 percent in patients with previously untreated multiple myeloma. After four and a half years of follow-up median survival has not been reached,” said Antonio Palumbo, M.D. Division of Hematology University of Torino, Torino, Italy. “Extended VELCADE-based therapy demonstrated a significant benefit across all efficacy endpoints in this elderly, non-transplant eligible population.”

Meta-Analysis of the Efficacy and Safety of Bortezomib Retreatment in Patients with Multiple Myeloma (Abstract #1863)

The primary objectives of this study were to evaluate the efficacy and safety of VELCADE retreatment in patients with R/R MM. This meta-analysis of 23 VELCADE-based studies (administered IV) included 1,051 patients previously treated with VELCADE. Results, which were presented by Kevin B. Knopf, M.D., California Pacific Medical Center, Sutter Health in San Francisco, CA, showed:

Across studies in which overall response rate (ORR) data were available, the pooled, weighted average ORR was 39 percent (95 percent CI:31percent, 47 percent)

ORR was 57 percent in relapsed only patients and 23 percent in refractory only patients

The pooled, weighted average median time to progression (TTP) was 7.5 months, median progression free survival (PFS) was 5.8 months and median overall survival (OS) was 16.6 months

TTP was 8.5 months in relapsed only patients and not available for refractory only patients

OS was 19.7 and 11.2 months for relapsed only and refractory only patients, respectively

Most common adverse events included; thrombocytopenia (45 percent), anemia (33 percent), neutropenia and upper respiratory tract infection (25 percent), peripheral neuropathy ( 24 percent), renal insufficiency (16 percent), and pneumonia (6 percent)

Random effect pooled estimates of grade 3/4 adverse events included thrombocytopenia (38 percent), neutropenia (17 percent), anemia (16 percent), pneumonia (10 percent) and peripheral neuropathy (4 percent)

Using PubMed and major hematology/oncology conference proceedings, a systematic literature review was performed to identify studies from January 2005 to May 2012 of VELCADE-based therapy in patients with R/R MM. All studies of VELCADE-based retreatment in MM patients with prior exposure to VELCADE were systematically selected.

Overall Survival Benefit for Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance with Bortezomib-Thalidomide (VMPT-VT) Versus Bortezomib-Melphalan-Prednisone (VMP) in Newly Diagnosed Multiple Myeloma Patients (Abstract #200)

The data presented represent a median 54-month follow-up of the overall survival (OS), progression-free survival (PFS) and time to next therapy (TTNT) for VMPT-VT vs. VMP alone in newly diagnosed MM patients from a multicenter phase 3 randomized trial. Results, which were presented by Antonio Palumbo, M.D., University of Torino in Torino, Italy, showed:

511 patients were randomized

At the median follow-up of 54 months the median OS was not reached in the VMPT-VT arm and was 60.6 months in the VMP arm, (HR 0.70, p<0.01), corresponding to a 30 percent reduced risk of death

The median PFS was 33.1 months in the VMPT-VT arm, compared to 24.8 months in the VMP arm, (HR 0.61, p<0.0001)

Median TTNT was 46.6 months in the VMPT-VT arm, compared to 27.8 months in the VMP arm, (HR 0.52, p<0.0001)

During VT maintenance, four percent of patients experienced grade 3/4 peripheral neuropathy, three percent grade 3/4 hematologic toxicity, one percent grade 3/4 infection and 13 percent discontinued due to adverse events

Patients were randomized to receive nine 6-week cycles of VMPT-VT (induction: VELCADE 1.3 mg/m2, d 1, 4, 8, 11, 22, 25, 29, 32, cycles 1–4, d 1, 8, 22, 29, cycles 5–9; melphalan 9 mg/m2 d 1–4, prednisone 60 mg/m2, d 1–4, thalidomide 50 mg d 1-42; maintenance: VELCADE 1.3 mg/m2 every 14 days and thalidomide 50 mg/day up to 2 years) or VMP alone. After the inclusion of 139 patients, the protocol was amended: both VMPT-VT and VMP induction schedules were changed to nine 5-week cycles and VELCADE schedule was modified to weekly administration (1.3 mg/m2 d 1,8,15,22, all cycles).

About VELCADE

VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 350,000 patients worldwide.

Important Safety Information

VELCADE® (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with diabetes may require close monitoring and adjustment of their medication.

VELCADE can cause serious side effects, including:

Peripheral neuropathy. Nerve problems, which can be severe including muscle weakness, tingling, burning, pain, or loss of feeling in the hands and feet.

Low blood pressure. A drop in blood pressure resulting in dizziness, light headedness or fainting.

Heart problems. Heart rhythm problems and heart failure including worsening of existing conditions. Symptoms may include chest pressure or pain, palpitations, swelling of the ankles or feet, or shortness of breath.

Lung problems, some of which have been fatal. Symptoms include cough, shortness of breath, wheezing or difficulty breathing.

Liver problems. Liver failure including a yellow discoloration of the eyes and skin.

Posterior reversible encephalopathy syndrome (PRES). a rare, reversible condition involving the brain. Symptoms may include seizures, high blood pressure, headaches, tiredness, confusion, blindness, or other vision problems

Gastrointestinal problems. Nausea, vomiting, diarrhea and constipation.

Thrombocytopenia and neutropenia. Lowering the levels of blood cells, which could result in a higher risk for infections or bleeding.

Tumor lysis syndrome (TLS). TLS is a syndrome that causes a chemical imbalance in the blood that could lead to heart and/or kidney problems.

Common side effects seen in patients receiving VELCADE include: fever, decreased appetite, fatigue, rash.

These are not all of the possible side effects with VELCADE. Please see the full Prescribing Information for VELCADE for a complete list available at VELCADE.com.

Editor’s Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com/InTheNews.aspx.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:

Millennium

Manisha Pai, +1-617-551-7877

Manisha.pai@mpi.com

or

David Albaugh, +1-617-444-4456

david.albaugh@mpi.com

or

Takeda Pharmaceutical Company Limited

Corporate Communications Dept. (PR/IR)

+81-3-3278-2037



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