Merck Initiates Phase III Study of Stimuvax in Breast Cancer
STRIDE study will evaluate the efficacy and safety of the investigational therapeutic cancer vaccine, Stimuvax, in advanced breast cancer
Darmstadt, Germany, June 22, 2009 - Merck KGaA announced today the initiation of its global Phase III clinical study of the therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer. The STRIDE(a) study will determine if Stimuvax can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study. The STRIDE study will be supervised by an expert Steering Committee and is sponsored by Merck, which is leading the development of Stimuvax.
STRIDE will enroll more than 900 patients with advanced breast cancer at an estimated 180 sites in over 30 countries - within North America, Europe, Asia and Australia; the Principal Investigator is Dr Lawrence Shulman, Chief Medical Officer and Senior Vice President for Medical Affairs, Dana-Farber Cancer Institute, Boston, USA.
"Advanced-stage breast cancer remains a devastating and challenging disease and we urgently need new treatment options," said Dr Shulman. "If the results from the Phase III STRIDE study prove positive, this could make a difference for patients with hormone receptor positive metastatic breast cancer."
Stimuvax is an investigational therapeutic cancer vaccine designed to stimulate the body's immune system to identify and target cancer cells that express MUC1, an antigen commonly expressed in breast cancer as well as in other common cancer types such as non-small cell lung cancer (NSCLC), multiple myeloma, and colorectal, prostate and ovarian cancers.1
"The initiation of the STRIDE study is an enormous step forward in clinical breast cancer research and represents our continued commitment to developing Stimuvax within a robust clinical trial program across several cancer types. We are very excited that Stimuvax will now be tested in two different cancer types in phase III," said Dr Oliver Kisker, Senior Vice-President, Global Clinical Development Unit Oncology of Merck's division Merck Serono.
The Phase III program for Stimuvax was initiated following results from a randomized Phase IIb study* of 171 patients with inoperable stage IIIb NSCLC, in which Stimuvax showed a trend towards extending median overall survival from 13.3 months for patients receiving best supportive care (BSC) to 30.6 months for patients receiving Stimuvax plus BSC.2,3 Reported side effects included mild-to-moderate flu-like symptoms, gastrointestinal disturbances and mild injection-site reactions. A further long-term safety analysis in 16 patients receiving prolonged treatment with Stimuvax from 2 to 8.2 years showed the most common treatment-related adverse events were injection-site reactions (ISRs) with no evidence of autoimmune reactions. These data also show that the occurrence of ISRs decreased with long-term therapy (>1 year).4
Stimuvax was the first investigational cancer vaccine to enter Phase III clinical testing in NSCLC with the February 2007 launch of the STARTb study, which will involve more than 1,300 patients with unresectable stage III NSCLC, who were stable or responding after chemoradiotherapy.
Breast Cancer Facts
· Worldwide, more than a million women are diagnosed with breast cancer every year, including 430,000 women in the E.U. and 213,000 in the U.S.5
· Breast cancer is the leading cause of cancer deaths in women worldwide, resulting in approximately 519,000 deaths per year, globally.6
· Despite improved breast cancer survival rates, it is currently estimated that 28% of women diagnosed with invasive breast cancer in the E.U. and the U.S. will not live longer than 10 years.7,8
· On average, 30% of patients with early-stage breast cancer suffer a recurrence and in most cases, the cancer will have spread beyond the breast.9
· Approximately 70% of breast cancer patients are hormone-receptor positive and hormone therapy is a widely accepted treatment modality for these patients.10
(a) STRIDE STimulating immune Response In aDvanced brEast cancer
(b) START Stimulating Targeted Antigenic Responses To NSCLC
*The study was initially conducted by Oncothyreon. The long term follow-up was done by Merck.
1. Ho SB, et al. Cancer Res 1993;53(3):641-51.
2. Butts C, et al. J Clin Oncol 2005;23:6674-81.
3. Butts C, et al. J Thorac Oncol 2007;2(Suppl. 4):S332-3. Abstract No: B1-01.
4. Butts C, et al. ASCO Congress 2009; Abstract No: 3055.
5. Cancer Research UK. Breast cancer incidence statistics.
6. World Health Organization. Factsheet No 297. www.who.int/mediacentre/factsheets/fs297/en/
7. Peto R, et al. Lancet 2000;355:1822.
8. Cancer research UK. Predicted improvements in breast cancer survival.
9. Gonzalez-Angulo AM, et al. Adv Exp Med Biol 2007;608:1-22.
10. Anderson WF, et al. Breast Cancer Res Treat 2002;76:27-36.
For more information on Stimuvax, please visit: www.globalcancernews.com.
Merck is investigating the use of Stimuvax® (BLP25 Liposome Vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.
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.
STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study.
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Merck is a global pharmaceutical and chemical company with total revenues of € 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.