Cambridge, Mass. and Osaka, Japan, November 5, 2015 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that it will present Phase 3 data from the TOURMALINE-MM1 ixazomib clinical trial at the 57th American Society of Hematology (ASH) Annual Meeting to be held in Orlando, Florida from December 5 to 8, 2015. A total of 19 company-sponsored abstracts representing the breadth and depth of Takeda’s hematology-oncology portfolio were accepted for presentation at this year’s meeting.
“We are particularly looking forward to this year’s ASH annual meeting. We will be presenting pivotal data on the ixazomib program, as well as the five year overall survival data for ADCETRIS in relapsed/refractory Hodgkin lymphoma,” said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Therapeutic Area Unit, Takeda. “The success of these two programs, in addition to data we will be presenting on our pipeline, is the realization of decades of commitment to patients with hematological malignancies.”
“This is the first time Phase 3 data will be presented for ixazomib, an oral, once-weekly for 3 weeks of a 4 week treatment cycle, proteasome inhibitor which, if approved, would enable the first all-oral triplet regimen containing a proteasome inhibitor for the treatment of relapsed/refractory multiple myeloma,” said TOURMALINE-MM1 Principal Investigator Philippe Moreau, M.D., University of Nantes, France. “In working with Takeda Oncology on the evolution of proteasome inhibition, we continue to strive towards providing new options to address the unmet needs of patients with multiple myeloma.”
Ixazomib is the first oral proteasome inhibitor in late stage clinical development. The TOURMALINE-MM1 study is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial which was designed to evaluate the superiority of once-a-week oral ixazomib plus lenalidomide and dexamethasone vs. placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.
Ixazomib has been granted Priority Review from the U.S. Food and Drug Administration (FDA) and Accelerated Assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency , respectively, validating the profound and continuing unmet need for new multiple myeloma treatments. These submissions for the treatment of patients with relapsed and/or refractory multiple myeloma were based on the TOURMALINE-MM1 data.
Takeda’s presentations at ASH 2015 include the following:
- Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1 Study (NCT01564537)
- Presenter: Philippe Moreau, M.D., University of Nantes, France
- Abstract 727, Oral Presentation, Monday, December 7, 2015, 2:45 PM, Orange County Convention Center, Tangerine 2 (WF2)
- Randomized Phase 2 Study of the All-Oral Combination of Investigational Proteasome Inhibitor (PI) Ixazomib Plus Cyclophosphamide and Low-Dose Dexamethasone (ICd) in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Who Are Transplant-Ineligible (NCT02046070)
- Presenter: Meletios A. Dimopoulos, MD, University Athens School of Medicine, Athens,
- Abstract 26, Oral Presentation, Saturday, December 5, 2015, 7:45 AM, Orange County Convention Center, Tangerine (WF2)
ADCETRIS (Brentuximab vedotin)
- Five-year Survival Data Demonstrating Durable Responses from a Pivotal Phase 2 Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma
- Presenter: Robert Chen, MD, City of Hope National Medical Center, Duarte, CA
- Abstract 2736, Poster, Sunday, December 6, 2015, 6:00 PM, Orange County Convention Center, Hall A, Level 2
- Updated Efficacy and Safety Data from the AETHERA Trial of Consolidation with Brentuximab Vedotin after Autologous Stem Cell Transplant (ASCT) in Hodgkin Lymphoma Patients at High Risk of Relapse
- Presenter: John Sweetenham, MD, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah
- Abstract 3172, Poster, Sunday, December 6, 2015, 6:00 PM, Orange County Convention Center, Hall A, Level 2
- First Multicenter, Randomized Phase 3 Study in Patients (Pts) with Relapsed/Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL): Alisertib (MLN8237) Versus Investigator’s Choice (Lumiere trial; NCT01482962)
- Presenter: Owen O’Connor, MD, Center for Lymphoid Malignancies, Columbia University Medical Center, New York Presbyterian Hospital, New York, NY
- Abstract 341, Oral Presentation, Sunday, December 6, 2015, 5:30 PM, Orange County Convention Center, Hall E2
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.
ADCETRIS® (brentuximab vedotin) is an antibody drug conjugate (ADC) which received conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in 55 countries.
Alisertib (MLN8237) is an oral, selective, inhibitor of Aurora A kinase being investigated by Takeda for the treatment of small cell lung cancer. Aurora A kinase is required for cells to divide properly and has been shown to be over-expressed in a variety of cancers, and inhibition of Aurora A kinase represents a novel approach in cancer research.
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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