Takeda is walking away from orteronel, its most advanced oncology candidate, after the prostate cancer treatment failed to significantly improve overall survival in two studies, a setback for the company's in-transition Millennium unit.
The drug, formerly known as TAK-700, was the nearest to approval among Millennium's three Phase III oncology treatments, an oral therapy the company hoped could contend in the crowded market for prostate cancer drugs. But two late-stage misses have scuttled those plans, Takeda said, as orteronel failed to meet the co-primary endpoint of overall survival in one study and flunked on OS in an interim analysis of a second.
Those results likely would have made securing FDA approval a tough task, but they would almost certainly have made it difficult for Takeda to crack the cluttered market for prostate cancer treatments. Johnson & Johnson ($JNJ) leads the way with the oral Zytiga, which brought in $1.7 billion last year, while Astellas and partner Medivation ($MDVN) are gaining momentum with Xtandi, and Bayer may have a blockbuster on its hands with the recently approved Xofigo.
That competition leaves little room for orteronel, Takeda said.
"After careful consideration of the data from these trials, the company has determined that the drug has not demonstrated a clinical profile sufficient to move forward" in metastatic, castration-resistant prostate cancer, the company said, "given the availability of other therapies."
The termination also thins out Millennium's late-stage pipeline, now limited to ixazomib (MLN9708), a multiple myeloma treatment designed to succeed the company's blockbuster Velcade; and alisertib (MLN8237), in Phase III trials for peripheral T cell lymphoma.
Takeda is still in the midst of a sweeping reorganization of the cancer specialist it bought for $8.8 billion back in 2008. Last summer, Millennium CEO Deborah Dunsire stepped down and Takeda began trimming jobs and refocusing its oncology R&D efforts.
- read the statement