Merck lung cancer vaccine enters phase III trials
pharmafile | March 7, 2007 | News story | Research and Development |Â Â Â
A therapeutic vaccine for the most common form of lung cancer has enrolled its first patient into global phase III clinical trials.
Merck KGaA's Stimuvax is the first investigational lung cancer vaccine for advanced, inoperable non-small cell lung cancer (NSCLC) to reach this milestone.
Research so far indicates that Stimuvax (BLP25 liposome vaccine) stimulates the body's immune system to identify and destroy cancer cells expressing MUC1.
"Patients with advanced lung cancer are in need of new therapies that effectively target cancer cells while providing better safety and tolerability," said Dr Frances Shepherd, Director of Medical Oncology at Princess Margaret Hospital in Toronto and lead investigator of the START (Stimulating Targeted Antigenic Responses To NSCLC) study.
"Novel therapeutic vaccines such as Stimuvax may help the body's immune system identify and destroy cancer cells without targeting normal, healthy cells."
Therapeutic vaccines are a relatively new development in cancer treatment. Unlike preventative vaccines, they induce the body's own immune system to identify and kill existing cancer cells.
Aimed at people with unresectable stage III (NSCLC), Stimuvax works by inducing an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers, but which is over-expressed in lung, breast and colorectal cancer.
Lung cancer accounts for 80% of global cancer-related deaths in both men and women. Around 15% of people with NSCLC survive five years after diagnosis. Current treatments for NSCLC include Roche's Tarceva and Sanofi-Aventis' Taxotere.
Stimuvax was developed by Canadian biotech company Biomira following studies funded by Cancer Research UK.
The phase III START trials will involve 1,300 patients in 30 countries and in the UK research centres in Edinburgh, Leeds and Exeter will be participate.
The START study, which has used advice from the European Medicines Agency and was agreed by the US Food and Drug Administration (FDA), is a randomised, double-blind, placebo-controlled evaluation of patients who have responded or had a stable disease – after two cycles of platinum-based chemo-radiotherapy.
The FDA gave Stimuvax fast-track status in September 2004. Merck has the worldwide licensing rights to the drug other than in Canada, where it will share with Edmonton-based Biomira.
In a randomised Phase IIb study, Stimuvax has already shown a median survival of 30.6 months versus 13.3 months in the control group – an improvement of 17.3 months. Side effects of the drug included flu-like symptoms.
