One of Takeda's big cancer bets flops in a Phase III lymphoma trial

Takeda CEO Christophe Weber

Alisertib, a jewel of Takeda's $8.8 billion acquisition of Millennium Pharmaceuticals back in 2008, failed to make the grade in a Phase III lymphoma trial, forcing the Japanese drugmaker to pull the plug and pivot to other indications.

Takeda was studying the drug, a kinase inhibitor designed to halt cancer cell proliferation, to see if it could significantly extend progression-free survival compared with standard of care in patients with peripheral T-cell lymphoma (PTCL). Taking a look at interim Phase III data, the company concluded that alisertib was unlikely to meet its primary goal, terminating the program after years of development.

Alisertib, formerly MLN8237, was a top project at Millennium when Takeda pulled the trigger on its costly deal, and the failure in PTCL leaves an ongoing Phase II program in small cell lung cancer and a pair of Phase I efforts in non-Hodgkin lymphoma and solid tumors.

"While we are disappointed that alisertib will not be further investigated for relapsed or refractory peripheral T-cell lymphoma, we are optimistic about alisertib's clinical development program in small cell lung cancer," Takeda Oncology chief Michael Vasconcelles said in a statement. "The randomized Phase II study of alisertib in small cell lung cancer will continue as planned and is currently underway."

The failure follows a similar setback for orteronel, a once-promising prostate cancer treatment that Takeda ditched last year after it came up short in Phase III. The company's most advanced cancer treatment is now ixazomib, an oral treatment for blood cancers that Takeda hopes can succeed its blockbuster Velcade. The drug won the FDA's coveted breakthrough-therapy designation late last year, and Takeda expects to submit it for approval in multiple myeloma later this year. Like alisertib, ixazomib is a matriculated Millennium project.

Meanwhile, the storied company is entering a new era under CEO Christophe Weber, its first non-Japanese leader. Weber has promised to return Takeda to growth through a series of budget cuts and a "stringent" approach to R&D spending, vowing to learn the lessons of a few painful clinical failures and regroup around its best bets to come away with a market leader.

- read the statement