According to the company, the data at 21 months of median follow up confirms a statistically- significant six-month increase in median survival (17.1 months in the experimental arm versus 11.3 months in the control arm) in patients with normal levels of activated natural killer cells at baseline (some 75% of the patients in the trial), a sub-population identified by Transgene’s biomarker program. The measurement of this biomarker is based on flow cytometry.
The results are consistent with previous reported data on the efficacy of the drug after 17 months of median follow-up, which were released in September 2008. Although the study is not yet closed, the clinical data is not expected to change significantly from what is reported, the company said.
Furthermore, results from the biomarker program provide evidence for a Th1 dependent pathway of activity for TG4010 in cancer patients. Transgene expects to submit more detailed clinical and biological data shortly.
The company plans to have meetings with the FDA and the European Medicines Agency during the second quarter of 2009 in preparation of a Phase III program in metastatic non-small cell lung cancer.
Philippe Archinard, CEO of Transgene, said: “We are pleased by the continued efficacy of our vaccine on such an important sub-population of patients suffering from advanced non-small cell lung cancer and by the progress made in our partnership discussions with potential pharmaceutical companies.”