GPC BIOTECH PRESENTS PFS DATA ON PROSTATE CANCER DRUG
Pharmion and GPC Biotech have presented final progression-free survival (PFS) results from the double-blind, randomized, Phase III registrational trial of satraplatin, the SPARC trial. The trial evaluated satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy. All analyses of PFS being presented were conducted on an intent-to-treat basis.
The study data show that satraplatin significantly reduces the risk of disease progression in these patients using the protocol-specified log-rank test. The hazard ratio of 0.6, which was first reported in September 2006, was adjusted for nine prespecified prognostic factors. Using a more conservative analysis, which adjusted only for the three pre-specified stratification factors, the hazard ratio is 0.67. These hazard ratio numbers correspond to a reduction in relative risk of disease progression of 40 percent and 33 percent, respectively.
The improvement in PFS in the satraplatin arm was not affected by the type of prior chemotherapy, and improvement was similar for patients who had received prior Taxotere (docetaxel), as well as for those who received other types of chemotherapy treatments. Fifty-one percent of patients in the trial were previously treated with Taxotere. The hazard ratio for patients in the SPARC trial who were previously treated with Taxotere was 0.67 and therefore numerically equivalent to the entire study population.
In accordance with the recommendation of the independent data monitoring board, patients who have not progressed continue to be treated, and all patients will be followed for overall survival. Overall survival data are expected to be available later this year. GPC Biotech recently completed the submission of a new drug application for satraplatin to the FDA. Pharmion expects to file a marketing authorization application in Europe in the second quarter of 2007.