On September 25, 2013 Infinity reported topline data from its Phase 2 study of retaspimycin hydrochloride (HCl) in patients with non-small cell lung cancer (NSCLC) who had a history of smoking. In this double-blind, randomized, 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. In the study, the safety profile of retaspimycin HCl plus docetaxel was comparable to docetaxel and placebo. Infinity expects to present the final data in a peer-reviewed setting after all analyses are complete. The company will not initiate any new trials with retaspimycin HCl (Press release Infinity Pharmaceuticals, SEP 25, 2013, View Source;p=irol-newsArticle&ID=1857866&highlight= [SID:1234500162]).
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. In addition, the combination did not show a treatment benefit in patient populations defined by pre-specified biomarkers, including KRAS, p53 and plasma levels of Hsp90-alpha. The safety profile of retaspimycin HCl plus docetaxel was comparable to docetaxel and placebo.
The Phase 2, randomized, placebo-controlled study evaluated the efficacy and safety of retaspimycin HCl plus docetaxel compared to placebo plus docetaxel in 226 patients with second- or third-line NSCLC who were naïve to docetaxel treatment and had a smoking history. Patients received 450 mg/m2 retaspimycin HCl or placebo dosed weekly in combination with the standard dose of docetaxel dosed once every three weeks during a 21-day cycle. The co-primary efficacy endpoints were overall survival in the entire patient population and overall survival in patients with squamous cell carcinoma.
Infinity today also announced that it will complete enrollment of the final cohort of patients in its separate, exploratory study of retaspimycin HCl in combination with everolimus (an mTOR inhibitor) in NSCLC patients with a KRAS mutation by the end of 2013 to conclude its development of retaspimycin HCl.
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