The biopharmaceutical company said it would now move forward with plans to use the final data from the Phase II trial, which are expected next year, as a basis for determining an appropriate clinical pathway for IDM-2101.
The Phase II trial with one year follow-up for survival was designed to assess overall survival and vaccine immunogenicity in HLA-A2 positive patients with stage IIIb, IV or recurrent non-small cell lung cancer. Patients were required to have tumor volume less than 125 cm squared with no limits on prior chemotherapy.
Updated one-year survival in patients treated with IDM-2101 was 60%, compared to 49% in a group of 72 patients who were HLA-A2 negative but otherwise comparable (external comparator group). Median survival for patients treated with IDM-2101 was 17.3 months compared to 12 months for patients in the comparator group. 91% of patients treated with IDM-2101, who were tested for immune response, had a measurable response to at least one of the epitopes included in the vaccine with 64% responding to at least three of the epitopes. Toxicities attributable to the vaccine were mild and consisted primarily of injection site reactions.