- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Lung Cancer Drug Retaspimycin Fails Phase II Study Goals
No improvement in survival versus placebo (September 25)
Disappointing results have been reported from a phase II study of retaspimycin hydrochloride, a selective heat shock protein 90 (Hsp90) inhibitor, in patients with non–small-cell lung cancer (NSCLC) who had a history of smoking.
In the double-blind, randomized, placebo-controlled study, retaspimycin did not meet its prespecified efficacy endpoints for demonstrating an improvement in overall survival in the total patient population or in a subset of patients with squamous cell carcinoma.
The drug’s developer (Infinity Pharmaceuticals) will not initiate any new trials with retaspimycin.
In the phase II study, the efficacy and safety of retaspimycin plus docetaxel were compared with those of placebo plus docetaxel in 226 patients with second- or third-line NSCLC who were naïve to docetaxel treatment and had a smoking history. The patients received retaspimycin 450 mg/m2 or placebo once weekly in combination with the standard dose of docetaxel administered once every 3 weeks during a 21-day cycle.
Source: Infinity Pharmaceuticals; September 25, 2013.