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positive long-term results from a phase II trial of Stimuva


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Promising Results Seen in Lung Cancer Trials

By Tracy Trundle

Merck KGaA reported positive long-term results from a phase II trial of Stimuvax for the treatment of non-small cell lung cancer (NSCLC). The drug is a MUC-1 peptide-based liposomal vaccine, for the potential treatment of cancers.

This study enrolled 171 subjects with stage IIIB/IV with stable or responding disease after any first-line chemotherapy with or without radiotherapy. The subjects were stratified by disease stage then randomized to receive Stimuvax plus best supportive care (BSC) or BSC alone.

The subjects in the Stimuvax arm received a single intravenous dose of cyclophosphamide 300mg/m2 followed by eight weekly subcutaneous immunizations with Stimuvax (1,000 mg).Although the overall study results did not reach statistical significance, the subjects with stage IIIB cancer receiving Stimuvax showed a median survival of 30.6 months compared with 13.3 months in the control group. At the three year follow-up, 49% of subjects who were treated with Stimuvax were still alive compared with 27% treated with BSC alone, representing a 45% reduction in mortality.

Based on the results, Merck KGaA is currently conducting a phase III trial of Stimuvax for the treatment of stage IIIA or IIIB NSCLC. Merck KGaA and Edmonton-based biotech Biomira entered into a development and commercialization licensing agreement for Stimuvax.


Also Pfizer released positive preliminary results from a phase II trial of sunitinib (Sutent), a multi-kinase inhibitor for the treatment of NSCLC. Sunitinib is already approved for the treatment of gastrointestinal tumors and renal cell carcinoma.

The trial was designed to compare sunitinib (37.5 mg/day) in combination with erlotinib (150 mg/day) in previously treated subjects with advanced NSCLC. The primary endpoint was safety and tolerability. Secondary endpoints included anti-tumor activity. The combination treatment was generally safe and well tolerated, with all adverse events mild to moderate in nature.

Two subjects had partial response; one which was maintained for more than three months and one which was currently ongoing. In addition, stable disease up to or more than 16 weeks was observed in two subjects. The randomized portion of this trial is currently underway.

Tracey Trundle is a Research Analyst at CenterWatch.

September 26, 2007 in All Posts, Clinical Trial Results | Permalink

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