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)

Abstract

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 evaluation on 140 evaluable patients are the following: in the experimental arm, 30/70 patients (43%; 95% CI 0.31–0.55) presented a confirmed partial response (PR) versus 18/70 (26%; 95% CI 0.16–0.36) in the control arm. Most adverse events (AEs) were considered related to chemotherapy or to underlying disease. Hematologic toxicity was equivalent in both arms. Most frequent AEs related to TG4010 were injection site reactions and asthenia, classical vaccine associated reactions. Preliminary immune response analysis indicates that both MUC1-specific and non-specific cellular immune responses are associated with the activity of TG4010. As median follow-up is 9 months, PFS, immune response and overall survival data are not yet mature but will be presented at the meeting. Conclusions: Based on preliminary data, the combination of TG4010 with first-line chemotherapy in NSCLC shows promising results with an increased response rate and a good safety profile. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Transgene SA Transgene SA Transgene