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ncbi.nlm.nih.gov
While this study showed rates of immune responders that were comparable to those observed in the Phase I study (and were not influenced by the administration of Cy), we observed a trend for prolonged survival in subjects receiving Cy (hazard ratio, HR = 0.57, p = 0.090). Strikingly, among immune responders, patients that were pre-treated with Cy had a significantly longer survival that those that were not (HR = 0.38, p = 0.040). This was not the case for patients that did not develop immune responses (HR = 0.92, p = 0.870), suggesting that both, an immune response and the immunomodulatory mechanism of Cy are required for improved survival of cancer patients receiving IMA901, and strongly arguing against any clinical single-agent activity of Cy. |
