Takeda Pharmaceutical Company Limited announced it will orally present the results of two studies at the 25th Congress of the European Hematology Association (EHA). Presentations are available online starting Friday, June 12, 2020, and include positive results from TOURMALINE-MM4, a Phase 3, randomized clinical trial evaluating the effect of single-agent oral NINLARO™ (ixazomib) as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation.
Takeda is also presenting key insights from the US MM-6 trial, which investigates the effectiveness and safety of an in-class transition to oral NINLARO in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who have previously received a parenteral bortezomib-based triplet induction therapy.
The TOURMALINE-MM4 trial achieved its primary endpoint, with treatment with NINLARO resulting in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation (hazard ratio [HR] 0.659; CI: 95; p <0.001). This corresponds to a 34% reduction in risk of progression or death in patients treated with NINLARO. The safety profile of NINLARO was consistent with previously reported results of single-agent NINLARO use and there were no new safety signals identified.
“There is a strong need for additional maintenance treatments for multiple myeloma, where currently approved options are limited,” said Meletios Dimopoulos, MD, University of Athens School of Medicine and principal investigator of the TOURMALINE-MM4 trial. “Data from this Phase 3 clinical trial reinforce the role of proteasome inhibition as a maintenance therapy and suggest that longer duration of therapy can improve a response, in addition to extending it. These data could be highly impactful for those who currently have limited options, which is often the case with patients not eligible for a stem cell transplant.”
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited 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.