Takeda’s Ninlaro (Ixazomib) Approved in Japan for First-Line Maintenance Therapy in Multiple Myeloma Patients Without Prior Stem Cell Transplantation

May 28, 2021 /BioonBIOON/ -- Takeda Pharmaceutical Company Limited (Takeda) recently announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the expansion of the indicated patient population for the oral proteasome inhibitor Ninlaro (ixazomib),Included patients who had not previously receivedStem cellsPatients with multiple myeloma (MM) post-transplant, or requiring maintenance therapy after first-line treatment.。

This approval is based on the results of the Phase 3 TOURMALINE-MM4 (NCT02312258) study of first-line maintenance monotherapy. This was a randomized, double-blind, placebo-controlled study that enrolled a total of 706 newDiagnosisFor multiple myeloma (MM) in patients who have not receivedStem CellsThe effect of Ninlaro as single-agent maintenance therapy compared with placebo on progression-free survival (PFS) was evaluated in patients who underwent transplantation and completed 6–12 months of initial therapy with a partial response or better.

The results showed that the study met the primary endpoint:Compared with the placebo group, patients in the Ninlaro group demonstrated statistically and clinically significant improvements in PFS (median PFS: 17.4 months vs 9.4 months; HR=0.659; 95% CI; p<0.001), corresponding to a 34.1% reduction in the risk of disease progression or death.

Notably, no new safety signals were identified in this study. Ninlaro maintenance therapy demonstrated a favorable safety profile and had no adverse impact on patients' quality of life. The safety profile of Ninlaro was consistent with previously reported results for Ninlaro monotherapy, with no new safety findings. The most common treatment-emergent adverse events (TEAEs) were nausea, vomiting, diarrhea, rash, peripheral neuropathy (PN), and fever.

36.6% of patients in the Ninlaro treatment group and 23.2% in the placebo group experienced ≥ Grade 3 TEAEs. New primary malignancies`Tumor`Incidence rate: 2% in the Ninlaro group and 6.2% in the placebo group. The proportion of patients who discontinued treatment due to TEAEs was low, at 12.9% in the Ninlaro group and 8% in the placebo group. In the study, the mortality rate was 2.6% in the Ninlaro group and 2.2% in the placebo group.

Principal Investigator of the TOURMALINE-MM4 Study, Department of Hematology, Nagoya City University HospitalTumorDr. Shinsuke Iida stated: “The TOURMALINE-MM4 study indicates that, in patients unsuitable`Stem Cells`"In transplanted patients with multiple myeloma, maintenance therapy with the oral proteasome inhibitor Ninlaro reduces the risk of disease progression and death by 34%. Ninlaro maintenance therapy is well tolerated in elderly patients and is not associated with an increased risk of secondary cancers. Therefore, regardless of clinical stage or the type of first-line remission-induction therapy, Ninlaro may be a promising treatment option to delay relapse."

Takeda JapanTumorBusiness Unit Head Takashi Horii stated: "I am pleased that, in addition to the existing indication for Ninlaro as maintenance therapy following autologous hematopoietic stem cell transplantation, the drug is now for patients who have not undergoneStem cellas maintenance therapy following first-line treatment for transplant patients, which means we can now offer this drug to a broader patient population. We will continue our efforts to bring this new therapy to patients in need.”

Ninlaro is the world's first oral proteasome inhibitor to be marketed, and was first approved in the United States in November 2015FDAApproved, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. To date, Ninlaro has been approved in multiple countries and regions, including the United States, Japan, and the European Union, with regulatory applications under review in several other countries. Currently, Ninlaro is being developed for various treatment settings in multiple myeloma.

In Japan, Ninlaro was approved by the Ministry of Health, Labour and Welfare (MHLW) in March 2017, in combination with lenalidomide and dexamethasone, for the treatment of relapsed or refractory multiple myeloma (R/R MM). In March 2020, Ninlaro received MHLW approval for use in patients with multiple myeloma undergoing autologous hematopoieticStem cellssubsequent maintenance therapy.

Multiple myeloma is a hematologic malignancyTumor, which originates from plasma cells, a type of white blood cell produced in the bone marrow. Normal plasma cells are responsible for producing antibodies that fight infection, while cancerous plasma cells—myeloma cells—proliferate extensively in the bone marrow and release an antibody known as paraprotein, which causes disease symptoms, including bone pain, frequent or recurrent infections, and fatigue,AnemiaSymptoms. These malignant plasma cells can affect multiple bones in the human body and may lead to severe health complications affecting the skeletal system, immune system, kidneys, and red blood cell count. The typical clinical course of multiple myeloma includes a symptomatic phase followed by a remission phase. It is estimated that there are approximately 230,000 multiple myeloma patients worldwide, with 114,000 new cases diagnosed annually. (Bioon.com)

Original Source: Marketingapproval Received in Japan for NINLARO as a Maintenance Therapy after First-Line Treatment for Multiple Myeloma without Prior Stem Cell Transplantation