Takeda Announces Results from Phase 3 Clinical Trial Evaluating NINLARO™ (ixazomib) in Newly Diagnosed Multiple Myeloma

- TOURMALINE-MM2 Data Presented Virtually at the Society of Hematologic Oncology (SOHO) Eighth Annual Meeting

CAMBRIDGE, MA, USA and OSAKA, Japan I September 9, 2020 I Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced results from the Phase 3 TOURMALINE-MM2 trial evaluating the addition of NINLARO™ (ixazomib) to lenalidomide and dexamethasone versus lenalidomide and dexamethasone plus placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant. These data will be presented at the virtual scientific meeting of the Society of Hematologic Oncology (SOHO) on Wednesday, September 9, 2020 at 6:15 p.m. CT.

The study found the addition of NINLARO to lenalidomide and dexamethasone resulted in a 13.5 month increase in median progression-free survival (PFS) (35.3 months in the NINLARO arm, compared to 21.8 months in the placebo arm; hazard ratio [HR] 0.830; p=0.073). The trial did not meet the threshold for statistical significance and the primary endpoint of PFS was not met.

“There is a specific need in newly diagnosed multiple myeloma, given there are currently no approved all-oral, proteasome inhibitor-based treatment options,” said Thierry Facon, MD, Lille University Hospital, principal investigator and lead author of TOURMALINE-MM2. “Findings from the TOURMALINE-MM2 trial are important overall for this patient population as well as across multiple subgroups including patients with high-risk cytogenetics. We hope these data will help inform future research and further progress for the multiple myeloma community.”

Other endpoints presented include complete response (CR) rate, overall survival (OS) and median time to progression (TTP). The safety profile associated with NINLARO from the trial was generally consistent with the existing prescribing information.

“We hope the findings from the TOURMALINE-MM2 trial will encourage constructive conversations and help progress future research efforts, particularly for patients who could benefit from an all-oral, proteasome inhibitor-based combination that helps preserve quality of life,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “As a company, we remain committed to the multiple myeloma community and look forward to sharing mature data from our ongoing Phase 3 multiple myeloma maintenance studies in the future.”

Key findings to be presented by TOURMALINE-MM2 trial investigator, Shaji Kumar, MD, Mayo Clinic, include:

  • In the prespecified expanded high-risk cytogenetics subgroup, median PFS was 23.8 months in the NINLARO arm versus 18.0 months in the placebo arm (HR 0.690).
  • The rate of CR, a key secondary endpoint in the trial, was 26% in the NINLARO arm versus 14% in the placebo arm.
  • After a median follow up of 57.8 months in the NINLARO arm versus 58.6 months in the placebo arm for OS, the median OS was not reached in either arm (HR 0.998).
  • Median TTP was longer with the NINLARO combination versus placebo, at 45.8 months in the NINLARO arm versus 26.8 months in the placebo arm (HR 0.738).
  • Safety data include:
    • Treatment emergent adverse events (TEAEs) were experienced by 96.6% of patients receiving NINLARO plus lenalidomide and dexamethasone compared to 92.6% of patients receiving placebo plus lenalidomide and dexamethasone.
    • The most common TEAEs of clinical importance in the NINLARO arm were diarrhea, rash, peripheral edema, constipation and nausea.
    • Grade ≥3 TEAEs were experienced by 88.1% of patients receiving NINLARO versus 81.4% receiving placebo.
    • The majority of TEAEs were managed without discontinuation, with TEAEs resulting in 35% regimen discontinuation in the NINLARO arm and 26.9% in the placebo arm.
    • The rate of on-study deaths was 7.6% in the NINLARO arm and 6.3% in the placebo arm.

“Insights from studies like TOURMALINE-MM2 are important, especially to those patients who may benefit from the convenience of treatment options that can be taken at home,” said Paul Giusti, President and Chief Executive Officer, Multiple Myeloma Research Foundation (MMRF). “These critical learnings enable the community to comprehensively assess the different treatment combinations available for patients and physicians.”

NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in more than 65 countries. NINLARO is not approved as a treatment for newly diagnosed multiple myeloma.

About the TOURMALINE-MM2 Trial

TOURMALINE-MM2 is an international, randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial, designed to evaluate NINLAROTM (ixazomib) plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone, in 705 adult patients with newly diagnosed multiple myeloma who are not candidates for transplant. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include rate of complete response (CR), pain response and overall survival (OS). For additional information: https://clinicaltrials.gov/ct2/show/NCT01850524

About Multiple Myeloma

Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission. Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.

About NINLAROTM (ixazomib) capsules

NINLARO™ (ixazomib) is an oral proteasome inhibitor which is being studied across the continuum of multiple myeloma treatment settings. NINLARO was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is currently approved in more than 65 countries, including the United States, Japan and in the European Union, with nine regulatory filings currently under review. It was the first oral proteasome inhibitor to enter Phase 3 clinical trials and to receive approval. In Japan, NINLARO is approved as a maintenance therapy in multiple myeloma patients who have undergone autologous stem cell transplant and has been filed for maintenance therapy in patients ineligible for stem cell transplant.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com.

SOURCE: Takeda Pharmaceutical Co

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