- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Lung Cancer Drug Reolysin Meets Primary Endpoint in Phase II Trial
Patients show objective tumor response (Mar. 28)
Reolysin (Oncolytics Biotech Inc.), a proprietary formulation of the human reovirus, met the primary overall statistical endpoint in a U.S. phase II study involving chemotherapy-naïve patients with metastatic (stage IIIB or IV) or recurrent squamous cell carcinoma of the lung (SCCLC). Intravenous Reolysin was administered in combination with carboplatin and paclitaxel.
The new study had a two-stage design, with a primary endpoint of the objective tumor response rate. A sufficient number of responses was observed in the first stage of the study to proceed with enrollment in the second stage. A total of up to 36 patients were to be evaluated in the second stage. The primary endpoint was met if nine or more patients in both stages combined had a partial response (PR) or better, which would yield a true response rate of 35% or more. This endpoint was met after 21 evaluable patients were treated. Nine of these patients exhibited PRs; nine showed stable disease (SD); and three had progressive disease (PD), for a response rate of 42.8% and a disease control rate (complete response [CR] + PR + SD) of 85.7%.
The American Cancer Society estimates that approximately 228,190 new cases of lung cancer will be diagnosed in 2013. Between 85% and 90% of all lung cancers are classified as non–small-cell lung cancer (NSCLC); squamous cell carcinomas account for 25% to 30% of all lung cancers. Lung cancer is the leading cause of cancer death in both men and women. An estimated 159,480 deaths from lung cancer will occur in the U.S. in 2013, accounting for approximately 27% of all cancer deaths. More people die each year from lung cancer than from colon, breast, and prostate cancers combined.
Source: Oncolytics Biotech; March 28, 2013.