Takeda, Amgen face a setback as lung cancer drug flunks Ph3

Three years after Japan's Takeda anted up $100 million to partner with Amgen on the cancer drug motesanib, investigators say that the wager failed to pan out in a late-stage study. Amgen, Takeda and its U.S. subsidiary Millennium jointly announced this morning that the Phase III study failed to demonstrate an improvement in overall survival when combined with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer.

"We are disappointed with the results from this trial, but look forward to further analysis of the data which may ultimately help inform future research in this area," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. Patients enrolled in the study were randomized to receive either paclitaxel, carboplatin and motesanib or paclitaxel, carboplatin, and placebo. The primary endpoint of the study was OS, and secondary endpoints included progression-free survival, objective response rate, association of placental growth factor with OS, duration of response, and safety and tolerability. Amgen unveiled only the top-line results from the study today. The details won't come out until later in the year.

Amgen sought out partners for some of its cancer drugs back in 2008 during a rocky period for the big biotech company. Its deal with Takeda was one way to gain additional backing for its experimental cancer therapies at a time its anemia drugs were coming under intense pressure in the marketplace. For Takeda the deal, part of a billion-dollar package with Amgen, represented a lunge into the biologics market with a chance to expand its cancer franchise outside the U.S.

- here's the joint release