GPC Biotech AG and Pharmion Corporation jointly announced the topline overall survival results for the double-blinded, randomised satraplatin phase 3 registrational trial, the satraplatin and prednisone against refractory cancer trial (SPARC).
The companies reported that the trial did not achieve the endpoint of overall survival. The median was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group and the hazard ratio was 0.97 (95 per cent CI: 0.83, 1.13).The companies are currently conducting pre-specified subset analyses.
The trial evaluated satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC).Based on the results, GPC Biotech is re-evaluating its development plans for satraplatin, including SPERA, the satraplatin expanded rapid access protocol in the US.
"We are extremely disappointed with the findings," said, Bernd R. Seizinger, chief executive officer, GPC Biotech. "We are currently discussing plans for the future development of satraplatin with our partners, Pharmion and Yakult. I would like to warmly thank and recognize the contributions of the investigators and patients, as well as their families, who participated in the SPARC trial."
"These results are clearly disappointing and will impact the EMEA review of our current marketing authorization application for satraplatin," said, Patrick J. Mahaffy, president and chief executive officer, Pharmion Corporation. "The key for our European submission now will be to conduct the pre-specified subset analyses and particularly to focus on the impact of prior Taxotere use, which we know is very important to the EMEA."
Pharmion's marketing authorization application with the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic HRPC who have failed prior chemotherapy was submitted in June 2007. The submission, based on the statistically significant progression-free survival results announced in September 2006, was timed so that overall survival data could be submitted during the review process. Pharmion plans to review the additional analyses and work closely with the EMEA to determine next steps for the filing.
While GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs, Pharmion is a leading global oncology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the US, Europe and additional international markets. GPC Biotech's lead product candidate is satraplatin, an oral platinum compound. The company has various anti-cancer programs in research and development that leverage its expertise in kinase inhibitors.