Stimuvax 3 year survival numbers Phase II trial DONE!

[RandyW]

DARMSTADT, Germany and SEOUL, South Korea | September 5, 2007 | 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.(1)

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% 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).(1,2) 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.

Based on these Phase II results, Stimuvax has entered its Phase III development and the START (Stimulating Targeted Antigenic Responses to NSCLC) trial is currently open for enrollment.

“The START study is the first Phase III program 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 program 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% of cases classified as NSCLC.(3) NSCLC survival rates at present are low, with only 16% of patients alive five years post diagnosis.(4) 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.

About the Phase II Trial

171 patients with ECOG 0-2 stage IIIB/IV NSCLC with stable or responding disease after any first-line chemotherapy with or without radiotherapy were randomized to receive Stimuvax plus best supportive care (BSC) or BSC alone. Patients were stratified by stage of disease (IIIB LR or stage IIIB with malignant pleural effusion and stage IV). Patients in the Stimuvax arm received a single i.v. dose of cyclophosphamide 300mg/m2 followed by 8 weekly sc immunizations with Stimuvax (1,000µg). While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIB locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group – an improvement of 17.3 months. In the Phase IIb study, side effects were primarily limited to flu-like symptoms, GI disturbances and injection site reactions.

About START – Phase III Trial

START is a multi-center, randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. For more information on the START study, or to find a participating center and eligibility criteria, go to www.nsclcstudy.com. The study is also listed on www.clinicaltrials.gov.

About Stimuvax

Merck is investigating the use of Stimuvax (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada. Stimuvax is being developed in Europe by Merck and in the United States by its affiliate, EMD Serono Inc.

References:

1. Butts, C. et al. A multi-centre phase IIB randomized controlled study of BLP25 liposome vaccine (L-BLP25 or Stimuvax) for active specific immunotherapy of non-small cell lung cancer (NSCLC): updated survival data. Presented at IASLC, 4 September 2007

2. Press Release Biomira Inc. April 2006.

3. Cameron, R. et al. Practice guidelines for non-small cell lung cancer. Cancer J Sci Am 1996, 2: S61.

4. American Cancer Society. Detailed Guide: Lung Cancer - Non-small Cell, What Are the Key Statistics for Lung Cancer?, revised 10/25/2006.

(http://www.cancer.org/docroot/CRI/conte ... p?sitearea, accessed 8/28/07)

SOURCE: Merck KGaA