BioCentury
ARTICLE | Clinical News

Tamibarotene: Phase IIb discontinued

May 13, 2013 7:00 AM UTC

CytRx discontinued a double-blind, international Phase IIb trial in 140 patients with stage IIIb/IV NSCLC after an interim analysis showed that first-line treatment with twice-daily oral tamibarotene plus paclitaxel and carboplatin was unlikely to meet the primary endpoint of improving PFS vs. placebo plus paclitaxel and carboplatin. CytRx made the decision based on a recommendation from the study's independent DSMB. No safety concerns were reported. The company said it will continue to make tamibarotene available on a compassionate use basis in the U.S. for patients with acute promyelocytic leukemia (APL), but has no plans to further develop the product. Tamibarotene is also marketed in Japan to treat relapsed or refractory APL. CytRx gained North American and European rights to tamibarotene through its acquisition of Innovive Pharmaceuticals Inc., which had rights from TMRC (see BioCentury, June 16, 2008). ...