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news.Transgene has reported promising preliminary data from the randomized, open-label and controlled Phase IIb trial evaluating its therapeutic vaccine TG4010 as an adjunct to first line chemotherapy in patients with advanced non-small cell lung cancer.
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This ongoing trial has been designed to assess the efficacy of TG4010 (MVA-MUC1-IL2) in combination with cisplatin and gemcitabine compared to the chemotherapy regimen alone. The patients in the trial had non-small cell lung cancer (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 favorable 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.
Philippe Archinard, CEO of Transgene, said: “We report today encouraging trends on the preliminary results of our Phase IIb trial with TG4010 in NSCLC. We expect to present data during the second quarter of this year and final data by the fourth quarter of 2008.”