/R E P E A T -- Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for ixazomib, First and Only

Data reveals ixazomib significantly extends progression-free survival for patients with relapsed/refractory Multiple Myeloma

OAKVILLE, ON, Dec. 6, 2015 /CNW/ - Takeda Pharmaceutical Company Limited today announced results from the TOURMALINE-MM1 trial, showing that treatment with ixazomib capsules is effective in extending Progression Free Survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone. These results were presented at the 57^th American Society of Hematology (ASH) Annual meeting in Orlando, Florida.

Ixazomib, currently not available in Canada, is the first oral proteasome inhibitor with once-weekly dosing in late stage clinical development. Ixazomib enables the first all-oral triplet regimen for the treatment of relapsed/refractory multiple myeloma, a devastating, relapsing and incurable rare cancer. On November 20, 2015, the U.S. Food and Drug Administration (FDA) approved ixazomib capsules under Priority Review status.

"The TOURMALINE-MM1 study results provide further data that support the safety and efficacy profile of ixazomib for the treatment of relapsed/refractory multiple myeloma," said Dr. Chaim Shustik, a hematologist at the McGill University Health Centre (MUHC) in Montreal and Professor of Medicine and Oncology at McGill University. "As a physician treating patients with this life-threatening disease, I am encouraged by the results of this important trial demonstrating the benefit of ixazomib in extending progression-free survival with a manageable toxicity profile."

Multiple myeloma – the second most common blood cancer – is a rare cancer of the plasma cells, which are found in the bone marrow. Myeloma develops when abnormal plasma cells in the bone marrow begin to divide uncontrollably and make more abnormal plasma cells. Over time, the myeloma cells build up in the bone marrow, making it difficult for other blood cells in the bone marrow to develop and work normally. The buildup of myeloma cells in the bone marrow can upset the balance of certain minerals in the body. The myeloma cells also make a substance that leads to bone damage and high levels of calcium in the blood. Myeloma cells also make abnormal proteins that can affect other organs such as the kidneys. In Canada, it is estimated that approximately 7,500 people live with multiple myeloma, with 2,700 new cases estimated to be diagnosed in 2015^ⁱ.

"Over the years, there has been significant progress made in the area of treatment for multiple myeloma; however, we still do not have a cure," said Francine Gendron, CEO, Myeloma Canada. "Patients living with multiple myeloma, and their physicians, are seeking newer treatment options to help maintain their remissions. And, these encouraging results provide additional hope of increased survival and higher quality of life to patients living with this devastating and incurable cancer."

"We aspire to deliver innovative medicines and novel therapies to patients with cancer as quickly, effectively and safely as possible," said Chatrick Paul, General Manager at Takeda Canada. "The pivotal data from the ixazomib program reinforces Takeda's commitment to ongoing research in the area of multiple myeloma with the overall goal of helping improve the lives of cancer patients and their families. We are thrilled that we were able to share these significant results yesterday with members of the American Society of Hematology during this year's annual meeting."

The abstracts presented include the Phase 3 TOURMALINE-MM1 study (Abstract #727): 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), by Philippe Moreau, M.D., from the University of Nantes, France. TOURMALINE-MM1 (n= 722) is the first double-blind, placebo-controlled trial with a proteasome inhibitor. Trial results demonstrate a statistically significant and clinically meaningful (35%) improvement in PFS, with patients treated in the ixazomib arm living for a significantly longer time without their disease worsening compared to patients in the control arm (20.6 months vs. 14.7 months in control group; HR 0.74; 95% CI 0.59 to 0.94; p = 0.012). Overall response rate (ORR) was 78.3% in the ixazomib arm and median duration of response was 20.5 months, versus 71.5% and 15 months in the control group. Ixazomib also showed efficacy in patients with high risk disease and cytogenetic abnormalities. Results demonstrated that median PFS more than doubled in the overall high-risk population (21.4 months in the ixazomib regimen compared to 9.7 months in the placebo regimen). A subsequent exploratory analysis of PFS was conducted (median follow-up 23.3 and 22.9 months in the IRd and placebo-Rd arms); median PFS 20 vs 15.9 months. The most common adverse events in the TOURMALINE-MM1 trial for patients receiving ixazomib included diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.

The TOURMALINE-MM1 trial is currently ongoing. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.

About Ixazomib
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. There are currently 20 Phase 3 clinical trial sites in Canada.

The TOURMALINE 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:

In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally, including in Canada.

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 people worldwide through leading innovation in medicine. Additional information about Takeda is available at takeda.com.

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and marketing organization of Takeda Pharmaceutical Company Limited. Takeda Canada is evolving to become an agile specialty pharmaceutical company, focusing on gastroenterology and oncology, while continuing to meet a number of important primary care needs. Additional information about Takeda Canada is available at takedacanada.com.

To read this news release in French, please visit Takeda Canada's website, media section.

For further information: Media Contacts: Natacha Raphael, Corporate Communications, Takeda Canada Inc., 905-465-4149, Natacha.raphael@takeda.com; Janet Grdovich, Account Director, Argyle Public Relationships, 647-899-1409, jgrdovich@argylepr.com

/R E P E A T -- Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for ixazomib, First and Only Once-Weekly Oral Proteasome Inhibitor for Multiple Myeloma/

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