Takeda's top oncology prospect met its main goal in a Phase III trial, the Japanese drugmaker said, paving the path to an FDA submission for a drug the company hopes can succeed its blockbuster Velcade.
In an interim analysis of a 722-patient trial, Takeda's ixazomib beat out placebo in extending progression-free survival for multiple myeloma sufferers who have failed prior treatments. Patients received standard cancer therapies lenalidomide and dexamethasone in addition to either ixazomib or sugar pill, and those in the treatment arm lived significantly longer without their disease worsening, Takeda said. The trial is still ongoing with secondary goals including overall survival and overall response rate.
The company isn't disclosing detailed data but said it intends to submit the results to regulatory authorities in hopes of locking down a multiple myeloma approval for the drug. Ixazomib is also in late-stage development for systemic light-chain (AL) amyloidosis, a related disease in which amyloid builds up and damages organs in the body, and has received the FDA's coveted breakthrough therapy designation in that indication.
Ixazomib, an oral treatment, is Takeda's most-advanced oncology asset after the company pulled the plug on the Phase III prostate cancer treatment orteronel last year. The drugmaker is also at work on alisertib, a Phase III lymphoma treatment, and a handful of Phase II drugs for gastric, pancreatic, prostate and breast cancers. Each of Takeda's late-stage cancer drugs is a vestige of the former Millennium Pharmaceuticals, which Takeda acquired for $8.8 billion in 2010 to get its hands on the already-approved Velcade and become a major oncology player.
Now the Japanese drugmaker is soon to anoint its first foreign chief, as current Chief Operating Officer Christophe Weber prepares to take the spot later this year with the goal of creating a slimmer operation. Takeda has already set out to cut about $1 billion from its budget and shed nearly 3,000 jobs around the world, and Weber has said the company will be "stringent" about its R&D spending, learning the lessons of a few painful clinical failures and regrouping around its best bets to come away with a market leader.
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