Takeda to Highlight Ixazomib Clinical Development Program at Upcoming International Myeloma Workshop
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it will highlight the ixazomib clinical development program during multiple poster sessions at the upcoming 15th International Myeloma Workshop (IMW 2015) to be held in Rome, Italy, from September 23 to 26, 2015.
“IMW presents an important opportunity for the multiple myeloma community to come together,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Therapeutic Area Unit, Takeda. “Ixazomib’s TOURMALINE program, which we anticipate will have over 3,000 patients when fully enrolled, is the embodiment of Takeda’s commitment to addressing the unmet needs in multiple myeloma, and now contains a pivotal trial in every major segment of this patient population. We look forward to presenting an overview of this program at IMW and engaging with our partners in the fight against multiple myeloma.”
Ixazomib is currently under review with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed and/or refractory multiple myeloma, and has been granted accelerated assessment and priority review, respectively. The regulatory submissions are based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of once-a-week oral ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Additional filings in other countries are planned to begin this year. Ixazomib is the first oral proteasome inhibitor in late stage clinical development for the treatment of patients with multiple myeloma.
Ixazomib presentations at IMW 2015 are as follows:
|
Format/Timing: |
Poster Discussion; Thursday, September 24, 2015 (6:40-7:40 p.m. CEST) |
|
|
Abstract No: |
0110 |
|
|
Abstract Title: |
Four Phase 3 Studies of the Oral Proteasome Inhibitor (PI)
Ixazomib for Multiple Myeloma in the
|
|
| Authors: |
Jesus San Miguel, Philippe Moreau, Vincent Rajkumar, Antonio
Palumbo, Thierry Facon, Gareth Morgan, Robert Orlowski, |
|
| Location: | Poster Area, 1st Floor | |
|
Format/Timing: |
Poster Display; Friday, September 25, 2015 (6:40-7:40 p.m. CEST) |
|
|
Abstract No: |
0112 |
|
|
Abstract Title: |
The Current Unmet Medical Needs in the Treatment and Management of Multiple Myeloma (MM) |
|
| Authors: | Paul Richardson, Antonio Palumbo, Maria-Victoria Mateos, Helgi van de Velde, Tomas Skacel, Sagar Lonial | |
| Location: | Poster Area, 1st Floor | |
|
Format/Timing: |
Poster Discussion; Thursday, September 24, 2015 (6:40-7:40 p.m. CEST) |
|
|
Abstract No: |
0167 |
|
|
Abstract Title: |
Phase 3 Study of the Oral Proteasome Inhibitor Ixazomib for Relapsed/Refractory AL Amyloidosis: TOURMALINE-AL1 |
|
| Authors: | Giampaolo Merlini, Angela Dispenzieri, Deborah Berg, Douglas V. Faller, Ai-Min Hui, Raymond L. Comenzo | |
| Location: | Poster Area, 1st Floor | |
|
Format/Timing: |
Poster Discussion; Friday, September 25, 2015 (6:40 – 7:40 p.m. CEST) |
|
|
Abstract No: |
0177 |
|
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Abstract Title: |
Safety Profile of Oral Ixazomib: Experience from 761 Patients Across 14 Phase 1 or Phase 1/2 Clinical Studies |
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| Authors: | Sagar Lonial, Kathleen Colson, R. Donald Harvey, Shaji Kumar, Ai-Min Hui, Guohui Liu, Deborah Berg, Paul Richardson | |
| Location: | Poster Area, 1st Floor | |
About Ixazomib and the TOURMALINE Trials
Ixazomib is an
investigational oral proteasome inhibitor which is being studied in
multiple myeloma, systemic light-chain (AL) amyloidosis, and other
malignancies. Ixazomib was granted orphan drug designation in multiple
myeloma in both the United States and Europe in 2011 and for AL
amyloidosis in both the U.S. and Europe in 2012. Ixazomib received
Breakthrough Therapy status by the U.S. FDA for relapsed or refractory
AL amyloidosis in 2014. It is also the first oral proteasome inhibitor
to enter Phase 3 clinical trials.
Ixazomib’s clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:
- TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
- TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
- TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
- TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
- TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov.
About Multiple Myeloma
Multiple myeloma is a cancer of the
plasma cells, which are found in the bone marrow. In multiple myeloma, a
group of plasma cells, or myeloma cells, becomes cancerous and
multiplies, increasing the number of plasma cells to a higher than
normal level. Because plasma cells circulate widely in the body, they
have the potential to affect many bones in the body, possibly resulting
in compression fractures, lytic bone lesions and related pain. Multiple
myeloma can cause a number of serious health problems affecting the
bones, immune system, kidneys and red blood cell count, with some of the
more common symptoms including bone pain and fatigue, a symptom of
anemia. Multiple myeloma is a rare form of cancer with approximately
39,000 new cases in the EU and 114,000 new cases globally per year.
About Takeda Oncology
Takeda Oncology is the brand for the
global oncology business unit of Takeda Pharmaceutical Company Limited.
Takeda aspires to cure cancer by delivering novel medicines to meet the
unique and urgent needs of people living with cancer, their loved ones
and the health care providers who support them around the world. Takeda
is the 11th largest global oncology company with a portfolio
of paradigm-changing therapies and an extensive pipeline of
investigational products that have the potential to significantly
improve patient outcomes across a number of cancers. By combining the
power of leading scientific minds with our agile and entrepreneurial
spirit and the vast resources of a global pharmaceutical company, Takeda
Oncology is finding new and innovative ways to improve the treatment of
cancer. Additional information about Takeda Oncology is available
through its website, www.takedaoncology.com.
About Takeda
Located in Osaka, Japan, Takeda (TSE:
4502) 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 people worldwide through leading innovation in
medicine.
Additional information about Takeda is available through its corporate website, www.takeda.com.
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Contact information
Takeda Pharmaceutical Company Limited
Japanese Media
Tsuyoshi
Tada, +81 (0) 3-3278-2417
tsuyoshi.tada@takeda.com
or
European
Media
Kate Burd, +44 7974 151510
kate.burd@takeda.com
or
Media
outside Japan/EU
Elizabeth Pingpank, +1 617-444-1495
elizabeth.pingpank@takeda.com
or
Amy
Atwood, +1 617-444-2147
amy.atwood@takeda.com
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