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Merck announces phase II trial results of Stimuvax vaccine
Darmstadt, Seoul | Thursday, September 6, 2007, 08:00 Hrs  [IST]

Merck KGaA has announced three-year survival results from a randomized phase II trial for the Stimuvax MUC-1 vaccine in non-small cell lung cancer (NSCLC) at the International Association for the Study of Lung Cancer (IASLC) Congress in Seoul, South Korea. The results suggest that Stimuvax combined with best supportive care (BSC) may provide survival benefits to patients with unresectable stage IIIB NSCLC who had either responded or had stable disease after initial radio-chemotherapy compared to patients receiving BSC alone.

The updated survival results show that more than twice as many patients were still alive at three years in the Stimuvax arm compared to BSC alone (49% / 17 patients vs 27% / 8 patients respectively), representing a 45 per cent reduction in mortality. As previously reported, patients with stage IIIB locoregional disease who received Stimuvax in this trial also experienced a 17.3 month difference in median survival compared to patients receiving BSC alone (30.6 months vs 13.3 months respectively). Patients receiving Stimuvax in this trial also reported mild to moderate side effects limited to flu-like symptoms, gastro-intestinal disturbances and mild injection-site reactions.

"The updated survival data are encouraging and support the need for further investigation via the ongoing phase III trial of Stimuvax as a maintenance therapy for patients with advanced lung cancer," commented Dr Charles Butts, from the Department of Medical Oncology, Cross Cancer Institute, Edmonton, Canada and lead investigator of the phase II study.

"The Start study is the first phase III programme to evaluate a therapeutic cancer vaccine in unresectable stage III non-small cell lung cancer, a disease area of high unmet medical need," said Dr Wolfgang Wein, senior executive vice president, Oncology, Merck Serono. "Our Stimuvax development programme forms part of our commitment to developing innovative targeted therapies to advance treatment options for patients with cancer."

Lung cancer is the leading cause of cancer-related deaths in both men and women worldwide, with approximately 80 per cent of cases classified as NSCLC.3 NSCLC survival rates at present are low, with only 16 per cent of patients alive five years post diagnosis. Unfortunately for most patients, current treatments provide limited success. Stimuvax has the potential to become an innovative cancer vaccine that stimulates the body's immune system to identify and destroy cancer cells expressing the protein antigen MUC1, which is widely expressed on common cancers including lung, breast and colorectal.

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