Messenger RNA vaccination in NSCLC: Findings from a phase I/IIa clinical trial.

2584 Background: CV9201 is a therapeutic cancer vaccine for non small cell lung cancer (NSCLC) based on a novel vaccination technology using self-adjuvanted mRNA molecules. It comprises five mRNAs encoding NSCLC associated tumor antigens (NY-ESO1, Mage-C1, Mage-C2, Survivin, 5T4). Here, we report interim results of a phase I/IIa trial with CV9201 in stage IIIb/IV NSCLC patients that responded or stabilized after first line (chemo-) radiotherapy. Primary endpoint was assessment of safety and tolerability of CV9201 and secondary endpoints were evaluation of induction of immune response and assessment of anti-tumor activity. Methods: Patients were vaccinated intra-dermally up to five times in max. 15 weeks. Blood samples were taken before the first vaccination and two weeks after the 3rd and 5th vaccination. 3 patients were vaccinated in the phase I part of the study at each of three different dose levels (400µg, 800µg and 1600µg total mRNA administered). Enrollment was then expanded at the highest dose leve...