- Data presented at the American Society of Clinical Oncology (ASCO) further support ongoing Phase III study of Stimuvax in NSCLC
- Development of Stimuvax adds to Merck KGaA’s leading oncology program and commitment to personalizing cancer care
ORLANDO, Fla. & DARMSTADT, Germany -- (BUSINESS WIRE) --
Extended follow-up safety data from a randomized Phase IIb study of patients with inoperable advanced (stage IIIb/IV) non-small cell lung cancer (NSCLC) have shown that the most common treatment-related adverse events observed in patients treated for up to 8.2 years with the investigational therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine) were mild injection site reactions and nausea, supporting investigation in Phase III clinical studies. The development of Stimuvax for NSCLC further demonstrates the commitment of Merck KGaA Darmstadt, Germany to personalizing cancer care with innovative, targeted therapies to advance oncology treatment.
This long-term analysis investigated the use of Stimuvax in 16 patients (median age 57.5 years) who received prolonged treatment for between 2.0 and 8.2 years. Of these, ten patients have been treated for more than 5 years and eight patients are still receiving treatment with Stimuvax. Injection site reactions decreased with treatment duration and there was no evidence of serious treatment-related adverse events or autoimmune reactions with prolonged treatment.1
These follow-up findings further support the ongoing investigation of Stimuvax in the Phase III study, STARTa, which will assess the efficacy and safety of this therapy in patients with unresectable stage III NSCLC. The primary endpoint is overall survival. In the original randomized Phase IIb study, Stimuvax showed a trend towards extending the survival of patients with locoregional stage IIIb NSCLC from 13.3 months in the control group to 30.6 months in the treatment group. Adverse events from the Phase IIb study included mild-to-moderate flu-like symptoms, gastrointestinal disturbances, and mild injection site reactions.2,3
Commenting on the latest findings, lead investigator Dr. Charles Butts, MD, University of Alberta Cross Cancer Institute, Edmonton, Alberta, Canada, said: “There is a huge unmet need in the treatment of advanced NSCLC. Prognosis is poor with at best 20% of patients surviving 5 years. If we see similarly positive efficacy and safety results in the Phase III study, START, and if Stimuvax is approved for use, we may have an important new treatment approach to offer patients with this devastating disease.”
Stimuvax is thought to work by engaging the body’s own immune system to identify and target cancer cells directly. Stimuvax targets the antigen MUC1, which is expressed on the surface of several tumor types and which plays multiple roles in promoting tumor growth and survival.4,5 Stimuvax was granted fast-track status by the FDA in September 2004.
“Stimuvax is part of Merck KGaA’s leading clinical oncology program to advance the personalized care of patients worldwide and was the first therapeutic cancer vaccine to enter global Phase III studies for stage III NSCLC,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck KGaA. “The randomized Phase IIb long-term safety results reported today further support these efforts, particularly when you consider that results were observed in patients with stage IIIb or IV NSCLC, who were alive and receiving Stimuvax for more than 2 years. Indeed, we are very encouraged to see that half the patients from the follow-up are still receiving treatment today after more than 8 years, where median survival time in this patient population is usually between 9 and 13 months.”
Burden of disease
- Every 30 seconds, someone, somewhere in the world dies of lung cancer
It is estimated that approximately 975,000 men and 376,000 women worldwide die from the disease each year6
- Globally lung cancer is the most common cause of cancer-related deaths in men and the second most common in women7
- Only 10% of people with lung cancer are alive 5 years after diagnosis, compared to 81% for melanoma and 75% for breast cancer8
- At diagnosis, most patients with NSCLC present with advanced, inoperable (also called unresectable) disease which is associated with a very poor prognosis9
- Approximately 25 to 30% of cases are diagnosed as locally advanced disease (stage III) and 40 to 50% are diagnosed as metastatic disease (stage IV)10
For more information on the START study log on to www.clinicaltrials.gov.
a START: S timulating T argeted A ntigenic R esponses T o NSCLC
References
1. Butts C, et al. ASCO Congress 2009; Abstract No: 3055. Updated information presented at meeting.
2. Butts C, et al. J Clin Oncol 2005;23:6674-81.
3. Butts C, et al. J Thorac Oncol 2007;2(8):S332-3. Abstract No: B1-01.
4. Yin L, et al. J Biol Chem 2004;279(44):45721-7.
5. Carraway KL 3rd, et al. Curr Top Dev Biol 2007;78:1-22.
6. American Cancer Society. www.cancer.org/downloads/STT/Global_Facts_and_Figures_2007_rev2.pdf.
7. World Health Organization. www.who.int/mediacentre/factsheets/fs297/en/.
8. Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.
9. Bunn PA, et al. Oncologist 2008;13(Suppl 1):1-4.
10. Pharmalicensing. http://pharmalicensing.com/public/articles/view/1127138004_432ec2d42045f
About Stimuvax
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.
About Merck
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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.
ASCO Abstract Number: 3055
CONTACT:
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