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Published on 7 December 2015

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Takeda presents data from Phase III TOURMALINE-MM1 study for NINLARO®

Takeda Pharmaceutical Company Limited announced results from the TOURMALINE-MM1 trial presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treatment with NINLARO® (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, randomised, double-blind, placebo-controlled Phase III clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

 

NINLARO was recently approved by the US Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The approval was based on the Phase III TOURMALINE-MM1 data, which were highlighted at the ASH press briefing. Ixazomib data will be featured in 18 presentations at this year’s ASH meeting, including an oral presentation on Phase II data from an investigational study evaluating the all-oral combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed multiple myeloma patients.

 

The data presented at ASH this year are the first major output from the comprehensive ixazomib clinical trial program, TOURMALINE, demonstrating Takeda’s ongoing commitment to providing effective and convenient treatment options for patients with multiple myeloma,” said Andy Plump, MD, PhD, Takeda Chief Medical and Scientific Officer. “The breadth and depth of the TOURMALINE programme allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib. We will continue this and other important clinical trials and look forward to sharing results over the next few years.

 

The comprehensive ixazomib clinical development program, TOURMALINE, includes a total of five pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis.

 

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 III Tourmaline-MM1 Study  (Abstract #727).

 

TOURMALINE-MM1 (n= 722) is the first double-blind, placebo-controlled trial with a proteasome inhibitor and has met the primary endpoint at the first interim analysis. Trial results demonstrate a statistically significant (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 versus 14.7 months in control group; Hazard Ratio [HR] 0.742; 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. Median PFS in high-risk patients (HR 0.543; HR 0.596 in patients with del(17p)) was similar to that in the overall patient population and in standard-risk patients. Adverse events observed with IRd were consistent with reported safety profiles for the individual agents. The most common gr ≥3 adverse events included neutropenia, anaemia, thrombocytopenia, and pneumonia. Gastrointestinal events included diarrhoea, nausea, and vomiting. Peripheral neuropathy (PN) rates were 28% in the IRd arm versus 21% in the control arm, 35% vs. 21% had rash events, 8% versus 10% had acute renal failure, and 4% versus 3% had heart failure.

 

The TOURMALINE-MM1 trial evaluated ixazomib plus lenalidomide and dexamethasone in some of the most common patient types in the relapsed/refractory multiple myeloma setting who are in urgent need of new treatment options due to the complex nature of this disease. This trial enabled us to gather efficacy and safety data across a large variety of patients such as older patients, patients with moderate renal impairment, light chain disease, and high risk cytogenetics,” said lead investigator and presenter Philippe Moreau, MD, University of Nantes, France.

 

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.

 

Takeda has submitted additional review applications for ixazomib to regulatory authorities around the world, including the European Medicines Agency (EMA), based on the TOURMALINE-MM1 data.



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