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Meta-Analysis of VELCADE® (bortezomib)-Based Induction Therapy Followed by Stem-Cell Transplantation Showed Significantly Greater Response and Longer Progression-Free and Overall Survival in Patients with Multiple Myeloma

Complete Response and near complete response significantly higher with VELCADE-based induction across patient subgroups, including those with high risk cytogenetics

CAMBRIDGE, MA, April 7, 2013Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced data from a meta-analysis of VELCADE-based regimens compared to non-VELCADE-based regimens as induction therapy prior to autologous stem cell transplant (ASCT) in patients with previously untreated multiple myeloma (MM). These data were reported in an oral presentation at the 14th International Myeloma Workshop (IMW) held April 3-7, 2013 in Kyoto, Japan.

The median progression-free survival (PFS) was significantly higher with VELCADE-based induction therapy compared to non-VELCADE-based: 35.9 months compared to 28.6 percent respectively (p<0.0001), at a median follow up of 37 months.  The post transplant combined complete response (CR) plus near-complete response (nCR) rate, was 38 percent (n=298) compared to 24 percent (n=182) percent respectively (p<0.0001), odds ratio of 2.05.  An odds ratio greater than 1 indicates the increased odds a patient will achieve an endpoint with one treatment over the odds of achieving that endpoint with a comparator-treatment. In the meta-analysis VELCADE-based induction treatment demonstrated a 23 percent overall survival benefit compare to non-VELCADE-based induction treatment, HR 0.81 (CI: 0.66-0.99) (P=0.04).

“This meta-analysis demonstrated that VELCADE-based induction therapy improved progression-free survival and overall survival in multiple myeloma patients who underwent autologous transplantation,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “With data from more than 1,500 patients, this meta-analysis underscores the extensive body of evidence, both in clinical trials and real-world experience, that exists for VELCADE.”  

Bortezomib-based versus non-bortezomib-based induction prior to ASCT in multiple myeloma: meta-analysis of phase 3 trials (Abstract #O-11)

The primary objectives of this analysis were to compare the post-transplant CR+nCR rates and PFS of VELCADE-based induction therapy (administered IV, twice weekly) with non-VELCADE-based induction in previously untreated patients with MM undergoing ASCT. Secondary endpoints included overall response rate (ORR) and overall survival (OS). This meta-analysis of three phase 3 studies included 1,572 patients. Results, which were presented by Pieter Sonneveld, M.D., Dept. of Hematology, Erasmus Medical Center, Rotterdam, the Netherlands, showed:

  • The integrated analysis, across these studies, reported the post-transplant CR+nCR for VELCADE-based regimens was 38 percent (n=298) compared to 24 percent (n=182) in non-VELCADE-based regimens (p<0.0001)
  • The median PFS was 35.9 months for VELCADE-based regimens compared to 28.6 months for non-VELCADE-based regimens (p<0.0001)
  • The ORR, post-transplant, was 79 percent (n=615) for VELCADE-based regimens compared to 68 percent (n=526) for non-VELCADE-based regimens (p<0.0001)
  • After a median follow-up of 37 months, the three year OS rates were 79.7 percent for VELCADE-based treatment compared to 74.7 percent for non-VELCADE-based treatment (HR 0.81 p=0.0402). Median OS has not been reached in either arm
  • Most common adverse events across the integrated analysis for VELCADE-based induction regimens compared to non-VELCADE-based induction, respectively, included; peripheral neuropathy (34 percent, 17 percent), constipation (31 percent, 28 percent) anemia (27 percent, 29 percent), nausea (28 percent, 27 percent), thrombocytopenia (31 percent, 22 percent) and leukopenia (25 percent, 27 percent)
  • Most common adverse events ≥Grade 3, VELCADE-based induction compared to non-VELCADE-based induction, respectively, included; leukopenia (14 percent, 15 percent), anemia (7 percent, 10 percent), thrombocytopenia (8 percent, 3 percent), peripheral neuropathy (6 percent, 1 percent), pneumonia (5 percent, 6 percent), neutropenia (4 percent, 6 percent), pyrexia (3 percent, 5 percent)

Patient-level data from three large phase 3 studies were pooled in a thorough integrated analysis of efficacy and safety. Data from a fourth study was included in a larger meta-analysis; however patient-level data was not available due to legal restrictions and is not included in the data reported here with the exception of the OS. The VELCADE-based regimens included VELCADE (Vc) plus dexamethasone (dex), Vc plus doxorubicin plus dex and Vc plus thalidomide (T) plus dex.  Non-Vc-based regimens included vincristine plus doxorubicin plus dex, and T plus dex.

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 400,000 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). TLSis 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

Contacts:
Millennium

Manisha Pai
+1-617-551-7877
Manisha.pai@mpi.com

David Albaugh
+1-617-444-4456
david.albaugh@mpi.com

Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037