Clinical Data From Phase I/II GVAX Vaccine Trial Updated.(Brief Article)

2002 JAN 16 - (NewsRx.com & NewsRx.net) -- Cell Genesys, Inc., reported further clinical data from its multicenter Phase I/II GVAX lung cancer vaccine trial that demonstrated a complete tumor response rate of 12% and a median response duration of greater than 11 months in patients with advanced non-small cell lung cancer who have failed chemotherapy and/or radiation therapy.

These data were presented on behalf of the GVAX Lung Cancer Clinical Investigators by Kristen Hege, MD, senior director of clinical research at Cell Genesys, at the International Conference of Gene Therapy of Cancer Meeting in San Diego, California, December 17, 2001.

The multicenter clinical trial reported by Cell Genesys included 36 evaluable patients divided into two groups - 26 patients with advanced lung cancer who failed prior therapy and ten patients with early stage lung cancer who were felt to be at high risk for recurrent tumor following surgical resection of their cancer. Of 26 patients with advanced-stage lung cancer, three patients, who had failed chemotherapy and/or radiation therapy, achieved a complete response - complete disappearance of metastatic tumors following treatment with GVAX lung cancer vaccine - two of which are ongoing at 11 and 16 months without further treatment for their cancer.

One of the three complete responders maintained a complete response for nine months, but then developed a local recurrence of lung tumor which was successfully treated with surgery, and the patient now continues without further evidence of tumor. In addition to these complete responses, seven patients (27%) achieved stable (nonprogressive) disease with a median duration of at least six months or greater. Included among these seven patients is one patient who achieved approximately a 30% total reduction in tumor size, which is continuing after 14 months without further treatment.

In addition to the responses in patients with advanced disease, 8 of the 10 patients with early stage lung cancer who received GVAX lung cancer vaccine following surgery, currently remain free of disease with a median follow-up time of twelve months. These patients also received no further treatment for their cancer after receiving GVAX vaccine and continue to be monitored for recurrent cancer.

"We are very pleased to report these updated clinical data for our GVAX lung cancer vaccine, particularly with respect to the duration of the complete responses which are very unusual in patients with advanced lung cancer who have failed chemotherapy," stated Joseph J. Vallner, PhD, Cell Genesys. "Based on these encouraging findings, GVAX lung cancer vaccine is expected to be the first of three potential Cell Genesys products to enter Phase III clinical trials during the next 12 to 18 months."

An interim report of this Phase I/II trial of GVAX lung cancer vaccine for which these updated results were reported, was presented at the American Society of Clinical Oncology ...