In September 2013 Infinity announced topline data from its Phase 2 study evaluating retaspimycin hydrochloride, or HCl, a novel, potent and selective inhibitor of heat shock protein 90, or Hsp90, in combination with docetaxel, a chemotherapy, in 226 patients with second or third-line non-small cell lung cancer, or NSCLC, who are naïve to docetaxel treatment and have a history of heavy smoking (Press release Infinity Pharmaceuticals, FEB 25, 2014, View Source [SID:1234500157]). In this randomized, double-blind, placebo-controlled study, retaspimycin HCl did not meet its pre-specified efficacy endpoints for demonstrating an improvement in overall survival in the total patient population or in patients with squamous cell carcinoma, despite observing partial responses in patients with squamous cell carcinoma during the Phase 1b testing. Additionally, the combination of retaspimycin HCl plus docetaxel did not show a treatment benefit in patient populations defined by pre-specified biomarkers, including KRAS, p53 and plasma levels of Hsp90-alpha. Infinity expects to present final data in a peer-reviewed setting after all analyses are complete.
Infinity has completed enrollment of the final cohort of patients in our separate, exploratory study of retaspimycin HCl in combination with everolimus (an mTOR inhibitor) in NSCLC patients with a KRAS mutation. Completing enrollment has concluded our development of retaspimycin HCl, and we will not initiate any new trials with retaspimycin HCl.

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