Phase III trial of Ninlaro meets goals in multiple myeloma

Takeda Pharmaceutical (TYO: 4502) has announced that the randomized, Phase III TOURMALINE-MM4 study of its multiple myeloma drug met its primary endpoint of progression free survival (PFS).

The trial evaluated the effect of single-agent oral Ninlaro (ixazomib) as a first line maintenance therapy versus placebo in adult patients diagnosed with multiple myeloma not treated with stem cell transplantation. TOURMALINE-MM4 is the first industry sponsored Phase III trial to explore the concept of “switch” maintenance, the use of medicines not included in initial induction therapy, in this setting. Ninlaro is currently not approved for this specific use.

“We are very encouraged by the results of the TOURMALINE-MM4 trial and continue our forward momentum in developing maintenance options for multiple myeloma patients. Importantly, this is the third positive Phase III readout from the TOURMALINE clinical trial program,” said Phil Rowlands, head of the Oncology Therapeutic Area Unit, Takeda. “We remain committed to bringing this convenient and well-tolerated treatment option to patients.”

The safety profile of Ninlaro in the maintenance setting was consistent with previously reported results of single-agent Ninlaro use, and there were no new safety signals identified in TOURMALINE-MM4.