In this study, MVA-MUC1-IL2 was administered simultaneously with cisplatin and vinorelbine in 44 stage IIIB/IV patients with non-small cell lung cancer (NSCLC).
The chemo-immunotherapy regimen achieved a tumor response rate of 37% with 71% of the patients exhibiting disease control (partial responses or stable disease for more than 12 weeks). All of the parameters used compared favorably to the results usually obtained with chemotherapy alone in this population of patients.
The results are particularly encouraging when considering the patient profile of the study population. The majority of the patients had stage IV disease and tumor characteristics associated with a poor prognosis.
This data also supports the positive results obtained from the recent prostate cancer phase II trial conducted with MVA-MUC1-IL2. Findings from this separate study of 40 men with rising prostate specific antigen (PSA) indicate that MVA-MUC1-IL2 is biologically active against prostate cancer. It is expected that MVA-MUC1-IL2 will prove effective in slowing disease progression in this form of cancer.
The vaccine also appears to be very well tolerated and no serious adverse events been observed during clinical trials to date.
“These encouraging data and especially the long survival of the patients presenting an immune response against MUC1 reinforce the concept of using vaccine therapy to treat cancer and to extend remission,” said professor Thierry Velu of the Erasme Hospital, Brussels.
Philippe Archinard, CEO of Transgene said: “This provides a strong basis supporting further development of the product. Our next step will be a multicentric, randomized, controlled study evaluating the impact of the vaccine in patients with the same profile who are being treated with standard chemotherapy. The study is expected to start by the end of 2005 and will enroll approximately 140 patients in the European Union”.