France’s Transgene has announced promising preliminary data from the Phase IIb trial evaluating its therapeutic vaccine TG4010 as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer.
The trial is designed to assess the efficacy of TG4010 (MVA-MUC1-IL2) 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.
Transgene said that the trial confirmed the favourable safety profile of TG4010 when associated to chemotherapy and most frequent adverse events related to the jab were injection site reactions and asthenia, “which are classical vaccine-associated reactions”. The firm’s chief executive Philippe Archinard said that final data will be presented by the fourth quarter of 2008.
