Randomized phase IIb trial evaluating the therapeutic vaccine TG4010 (MVA-MUC1-IL2) as an adjunct to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC)

8023 Background: TG4010 is a recombinant Modified Virus Ankara (MVA) expressing both IL2 and the tumor-associated antigen MUC1. Methods: This is a randomized, open label and multicenter study. Eligibility criteria were: histologically documented and untreated stage IIIB “wet”/IV NSCLC, MUC1 positive tumor, ECOG PS 0–1. Patients were randomized to receive: Cisplatin 75mg/m2 on d1 and Gemcitabine 1250mg/m2 on d1 and d8 every 3 weeks for up to 6 cycles with or without TG4010 which was continued upon progression. Tumors were evaluated every 6 weeks (WHO criteria). Primary endpoint was progression-free survival (PFS) at 6 months; secondary endpoints included overall survival, response rate, safety, quality of life and immune response. Results: 148 patients were randomized: 107 men / 41 women, mean age: 59 years, 134 patients with stage IV disease / 14 with stage IIIB, 105 patients with PS 1 / 43 with PS 0. Demographics did not differ between both arms. The preliminary efficacy results provided by local evaluat...