Takeda suffers another setback in its quest to expand myeloma drug’s reach — and blockbuster potential
Takeda has stumbled again in its quest to build up the blockbuster potential of its multiple myeloma drug Ninlaro. The pharma giant says the drug combined with dexamethasone failed to provide significant help for patients with rare cases of systemic light-chain amyloidosis, so now they’re scrapping the entire Phase III program.
The drug failed on the first primary endpoint on hematological responses, and researchers are throwing in the towel on organ deterioration and death, the second primary endpoint, with little expectation of success. The drug combo with dex was compared against a physician’s choice selection of dexamethasone plus either melphalan, cyclophosphamide, thalidomide, or lenalidomide; or dexamethasone alone.
We won’t have the numbers until a later scientific conference, but Takeda oncology chief Phil Rowlands said the trial was “one of the largest” mounted in this field. Patients suffering from amyloidosis experience an accumulation of amyloid in organs, which can trigger eventual organ failure.
Takeda has had high hopes for Ninlaro since its approval in 2015. But it also faces significant competition with a growing variety of drugs in the same market.
This latest setback on Ninlaro comes fast on the heels of another stumble earlier in the year, when the company said that it was withdrawing their application to sell the drug as a maintenance therapy for myeloma patients after stem cell transplants. Takeda had pursued that indication with positive progression-free survival stats, but the agency is holding out for overall survival data before they consider a green light.