IDM Pharma, Inc. today announced follow-up results from the Phase 2 study of IDM-2101 showing that the product candidate was well tolerated, induced broadly specific cytotoxic T lymphocyte (CTL) responses, and showed a positive survival trend in HLA-A2 positive patients with non-small cell lung cancer (NSCLC) who were treated with IDM-2101, compared to a parallel external control group of HLA-A2 negative non-treated patients.
"We continue to be encouraged by the positive trend in overall survival we are seeing in patients treated with IDM-2101," said Minal Barve, M.D., practice director, Mary Crowley Cancer Research Center. "Based on the results to date, further clinical study is warranted to confirm the potential of IDM-2101 as a treatment option for patients with non-small cell lung cancer."
Trial Design and Results
The Phase 2 open label, non-randomized trial, was designed to assess one-year patient survival, overall survival and vaccine immunogenicity in HLA-A2 positive patients with stage IIIb, IV or recurrent NSCLC. Patients were required to have tumor volume less than 125 cm2 with no limits on prior chemotherapy. Sixty-eight patients were enrolled in the trial (sixty-three treated with one or more doses) with the last patient enrolled in March 2006. Patients are still being followed for long-term survival.
Results are as follows: