The multi-center phase II study is being conducted according to a two-stage Simon trial design, in which the primary objective must be met in the first stage of the trial before proceeding to the second stage.
“The decision to proceed to the next step of this phase II study in breast cancer is encouraging. We look forward to presenting data in the first half of this year that will detail the response rates obtained in this trial to date,” said Dr Daniel Santi, chairman and CEO of Kosan.
KOS-862 is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel, and preclinical models have shown the compound to be effective against paclitaxel-resistant tumors. In addition to the phase II monotherapy trials in breast and prostate cancer, Roche and Kosan are evaluating KOS-862 in three ongoing phase Ib combination studies with Eli Lilly’s Gemzar, Bristol-Myers Squibb’s Paraplatin and Genentech’s Herceptin.