Showing posts with label Ixazomib’s phase 3 study. Show all posts
Showing posts with label Ixazomib’s phase 3 study. Show all posts

Thursday, December 3, 2015

Ixazomib’s phase 3 study in relapsed/refractory multiple myeloma presented


Takeda Pharmaceutical Company Limited 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.

The success of these two programs, in addition to data we will be presenting on VELCADE and our pipeline, is the realization of decades of commitment to patients with hematological malignancies.

Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Therapeutic Area Unit, Takeda.
“This is the first time Phase 3 data will be presented for ixazomib, an oral, once-weekly 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.