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news.Takeda Pharmaceutical said that the phase 3 TOURMALINE-MM2 study evaluating the addition of NINLARO (ixazomib) to lenalidomide and dexamethasone in certain multiple myeloma population could not deliver the desired results.
Takeda's TOURMALINE-MM2 study could not deliver statistically significant improvement in PFS. (Credit: J o/Wikipedia.org, GFDL, Cc-by-sa-2.5)
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The late-stage TOURMALINE-MM2 trial featured 705 adult patients who are newly diagnosed with multiple myeloma and are not candidates for transplant.
NINLARO is an oral proteasome inhibitor, which has approvals across more than 60 countries, including the US. It is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who were subjected to at least one prior therapy.
In the TOURMALINE-MM2 study, the addition of NINLARO to lenalidomide and dexamethasone showed an improvement in median progression-free survival (PFS) of 13.5 months. However, it could not meet the threshold for statistical significance, said Takeda Pharmaceutical.
PFS was the primary endpoint of the phase 3 trial, while the key secondary endpoints were rate of complete response (CR), pain response, and overall survival (OS).
NINLARO’s safety profile during the late-stage trial though was generally in line with the existing prescribing information of the drug.
Takeda Pharmaceutical 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 program.”
According to the Japanese pharma company, NINLARO has over 10 regulatory filings that are currently being reviewed. The drug became the first oral proteasome inhibitor to have advanced into phase 3 clinical trials and secured a regulatory approval.
