Declaring topline PhIII win, Takeda revives blockbuster hopes for its troubled multiple myeloma drug
Five months after dismal trial results convinced Takeda to scrap an entire Phase III program for their multiple myeloma drug Ninlaro, the Japanese giant announced a different late-stage trial has met its primary endpoint — although they have yet to release any data.
Ninlaro improved progression-free survival as a first-line maintenance treatment in a placebo trial of 706 patients who have not received a stem cell transplant and responded to 6-12 months of treatment, Takeda announced.
Takeda says they’ll present the data in full at an upcoming medical meeting.
The news comes less than half-a-year after the company axed a long-running effort to use Ninlaro on amyloidosis in the wake of a large trial failure. Seven years after launching the study, Takeda announced the TOURMALINE-AL1 trial failed to meet its primary endpoint of improving hematological response as a combination therapy.
The FDA okayed Ninlaro in 2015 as the first oral proteasome inhibitor and indicated it as a combination therapy for patients who had received at least one prior treatment, but sales didn’t keep up with Takeda’s hopes given an increasingly crowded multiple myeloma market. Only 10 days after Takeda got the FDA approval, AbbVie and Bristol-Myers Squibb were cleared for their injectable multiple myeloma therapy Empliciti.
The following year Takeda launched a 5,000-person real-world study to evaluate the drug. That study is ongoing.