Retaspimycin HCl Falls Short in NSCLC Trial

Infinity Pharmaceuticals announced data from its Phase 2 study of retaspimycin hydrochloride in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) who had a history of smoking. Retaspimycin HCL is a potent and selective heat shock protein 90 (Hsp90) inhibitor.

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This 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 450mg/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.

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. The combination of retaspimycin plus docetaxel did not demonstrate a treatment benefit in patient populations defined by pre-specified biomarkers, including KRAS, p53 and plasma levels of Hsp90-alpha.

Infinity will complete patient enrollment of a separate, exploratory study of retaspimycin HCl in combination with everolimus, an mTOR inhibitor in NSCLC patients with a KRAS mutation.

For more information call (617) 453-1000 or visit Infi.com.

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