Takeda Pharmaceutical Company has reported that its oral multiple myeloma drug Ninlaro (ixazomib) missed the progression-free survival (PFS) endpoint in the TOURMALINE-MM2 study.
The study was designed to evaluate the addition of Ninlaro to lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients.
Ninlaro is an oral proteasome inhibitor. In November 2015, it was approved by the US Food and Drug Administration (FDA) to be used in combination with lenalidomide and dexamethasone for the multiple myeloma treatment.
The study found that the addition of ixazomib to lenalidomide and dexamethasone resulted in an improvement in median progression-free survival (PFS) of 13.5 months. However, it did not meet the margin for statistical significance.
Takeda Oncology Therapeutic Area Unit head Christopher Arendt said: “There is a need for treatment options in transplant-ineligible patients. We remain committed to advancing the field of multiple myeloma and continue to drive innovation through ongoing research and development.
“We are confident there will be numerous learnings from this trial and look forward to sharing these data with the community. We want to thank the patients and investigators for their participation in this important programme.”
The study enrolled a total of 705 adult patients who were newly diagnosed with multiple myeloma and not eligible for transplant.
Complete response (CR), pain response and overall survival (OS) rates were the key secondary endpoints of the TOURMALINE-MM2 trial.
Takeda said that it will submit the results of the study to an upcoming medical congress. The company will also discuss the potential impact with study subjects.
Last November, Takeda reported positive results from the Phase III ALTA-1L clinical trial of Alunbrig in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).