Retaspimycin HCl: Development discontinued

Infinity said it will discontinue development of retaspimycin after top-line data from a double-blind, international Phase II trial in 226 docetaxel-naïve patients with second- or third-line NSCLC who had a history of smoking showed that once-weekly 450 mg/m 2 IV retaspimycin plus docetaxel missed the co-primary endpoints of improving OS in the overall patient population and in a subgroup of patients with SCC vs. placebo plus docetaxel. Additionally, retaspimycin plus docetaxel did not show a treatment benefit in subgroups defined by pre-specified biomarkers, including K-Ras, p53 and plasma levels of Hsp90 alpha. The safety profile of the retaspimycin regimen was comparable to that of the placebo regimen.

By year end, Infinity said it will complete enrollment of the final cohort of patients in a Phase Ib/II trial with retaspimycin in combination with everolimus in NSCLC patients with a K-Ras mutation to conclude development of retaspimycin. Infinity previously discontinued development of retaspimycin for other cancers, including breast cancer and gastrointestinal stromal tumors (GIST) (see BioCentury, April 20, 2009 & Aug. 9, 2010). In 2008, AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) ended a deal with Infinity to develop and commercialize retaspimycin after a portfolio review (see BioCentury, Dec. 15, 2008). ...