Additional follow-up of the hormone-refractory prostate cancer (HRPC) patients who received a dose comparable to that used in the company’s ongoing phase III program indicates that the median survival has not yet been reached and that the estimated median survival will be no less than 29.1 months.
Cell Genesys also presented, for the first time, an analysis of the survival data for the company’s two phase II trials of Gvax immunotherapy for prostate cancer, based on a published, validated nomogram that uses seven prognostic factors to calculate a patient’s predicted survival. This analysis demonstrated a favorable comparison of observed to predicted median survival for both phase II trials.
The company previously reported final median survival results from its first multi-center phase II trial of Gvax in 34 patients with metastatic HRPC, which showed an overall median survival of 26.2 months. The survival results from the two, independent multi-center phase II clinical trials are not only consistent with each other, but also compare favorably to the previously published median survival of 18.9 months for metastatic hormone-refractory prostate cancer patients treated with Sanofi-Aventis’ Taxotere (docetaxel) chemotherapy plus prednisone, the current standard of care for these patients.
Cell Genesys’ ongoing phase III program is designed to confirm this potential survival benefit for Gvax in prostate cancer. The company is currently enrolling two phase III clinical trials of approximately 1200 patients with metastatic HRPC, comprising one of the largest phase III clinical programs ever conducted in men with advanced prostate cancer.
“We are encouraged by the updated survival data from this second phase II trial of Gvax immunotherapy,” commented Dr Joseph Vallner, president and COO of Cell Genesys. “We continue to hope that Gvax immunotherapy for prostate cancer may some day offer an improved and less toxic treatment alternative to chemotherapy for patients with this disease.”
The new findings were reported at the 2006 American Society of Clinical Oncology (ASCO) Prostate Cancer Symposium in San Francisco, California.