for eMaxHealthTransgene announces promising preliminary data from the Phase IIb trial evaluating its therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).
This on-going trial is a randomized, open label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The trial completed the enrolment of 148 patients at the end of May 2007 and was conducted in 27 centres located in France, Poland, Germany, and Hungary. The patients had NSCLC expressing MUC1, either stage IIIB with effusion or stage IV, and had not received prior systemic treatment for their advanced disease. Half of the patients received the combination regimen (TG 4010 vaccine plus chemotherapy) and the other half of the patients received chemotherapy alone.
The trial confirmed the favourable safety profile of TG4010 when associated to chemotherapy: most adverse events observed so far were considered related to chemotherapy as well as to the underlying disease. Hematological toxicity was equivalent in both treatment groups. Most frequent adverse events related to TG4010 were injection site reactions and asthenia, which are classical vaccine associated reactions.
Based on the local evaluations performed at investigation centres, results so far are showing a positive trend in favour of the combination of TG4010 with the chemotherapy. These results nevertheless remain subject to a centralised review process that is presently on-going.
"We report today encouraging trends on the preliminary results of our Phase IIb trial with TG4010 in non-small cell lung cancer" said Philippe Archinard, Chief Executive Officer of Transgene. "We expect to present data during the second quarter of this year and final data by the fourth quarter of 2008."
About TG4010 cancer vaccine
TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination:
- MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate the immune response to antigens.
- MUC1 is a major tumor-associated antigen that provides a viable target for vaccination.
- TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1.
- The sequence coding for the cytokine Interleukin 2 (IL2) is included to help stimulate specific T-cell response.
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