Merck Serono breast cancer vaccine enters phase III
pharmafile | June 22, 2009 | News story | Research and Development | Cancer, Merck Serono, Stimuvax, vaccines
Merck Serono is to begin a global phase III study for its therapeutic cancer vaccine Stimuvax in patients with advanced, inoperable breast cancer.
Therapeutic vaccines are still a relatively new development in cancer treatment which, unlike preventative vaccines, induce the body's own immune system to identify and kill existing cancer cells.
The STRIDE study represents a major milestone for Merck, which is racing with biotech firms including Transgene, Dendreon and Antigenics to bring cancer vaccines to market.
Dr Oliver Kisker, senior vice-president of the global clinical development oncology unit at Merck Serono, said: "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."
The vaccine, which Merck is co-developing Stimuvax with US biotech firm Oncothyreon, first entered phase III trials in non-small cell lung carcinoma (NSCLC) in 2007, making it the first investigational cancer vaccine to reach that milestone.
That ongoing study involves more than 1,300 patients with unresectable stage III NSCLC who were stable or responding after chemoradiotherapy and has already shown promising results.
The new study in breast cancer will determine if the vaccine 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, tumour response and safety will also be assessed in this study. Merck has not indicated when it could bring the vaccine to market if the trials are successful.
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