On September 24, 2015 Takeda Pharmaceutical Company Limited (TSE: 4502) reported 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 (Press release, Takeda, SEP 23, 2015, View Source [SID:1234507529]).
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"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 Newly-Diagnosed, Relapsed/Refractory, and Maintenance
Settings: Tourmaline-MM1, -MM2, -MM3, and -MM4
Authors: Jesus San Miguel, Philippe Moreau, Vincent Rajkumar, Antonio Palumbo, Thierry Facon, Gareth Morgan, Robert Orlowski, Michele Cavo, Hermann Einsele, Frank
Neumann, Richard Labotka, Sagar Lonial, Paul Richardson
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
Abstract Title: Safety Profile of Oral Ixazomib: Experience from 761 Patients Across 14 Phase 1 or Phase 1/2 Clinical Studies
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.