Takeda's lung cancer drug motesanib fails--again--in Phase III odyssey

Takeda deal chief Ken Araki

Three years after Takeda decided to double down on motesanib for non-small cell lung cancer, in-licensing full rights to the drug from Amgen following their big Phase III failure in 2011, the company has once again come up empty-handed in a major late-stage test of the therapy.

Takeda originally partnered with Amgen ($AMGN) on AMG 706 back in 2008, paying $100 million upfront as the Big Biotech was working to lighten its R&D load. But three years later they were forced to acknowledge that their first Phase III for lung cancer had flopped. Takeda, though, was undeterred, latching on to a subset analysis of Asian patients which indicated that the drug could have a significant effect. Takeda then took on the role of sole developer and went back into Phase III with patients recruited in Japan, South Korea, Taiwan and Hong Kong.

Today, though, investigators were forced to acknowledge that the 7-year effort had missed the primary endpoint on progression-free survival among Stage IV patients. Top-line results alone were included in the announcement with no word on secondary endpoints for overall survival rates and objective response rates.

There was also no word from Takeda on what it plans to do now with the drug.

Just days ago, though, Takeda trumpeted the Phase III success of its top oncology prospect, noting that ixazomib beat out a placebo in extending progression-free survival for multiple myeloma patients who had failed prior treatments. That drug is intended to replace Velcade, which it also obtained in the $8.8 billion Millennium buyout.

Big changes are afoot at Takeda, with Christophe Weber set to take the helm with a plan to trim thousands of staffers and gain a better focus in R&D. Takeda deal chief Ken Araki told FierceBiotech at the JP Morgan Healthcare conference that the company can spend billions provided new deals can significantly improve its position in GI, oncology and emerging markets.

- here's the release (PDF)