GPC Biotech/Pharmion's next-generation oral platinum chemotherapy satraplatin failed to achieve the endpoint of overall survival as a second-line treatment in patients with hormone-refractory prostate cancer, the companies announced Oct. 30.

While GPC said it is "unlikely" that it will pursue a U.S. regulatory filing for the drug in that setting, the firm has ongoing trials of satraplatin in non-small cell lung cancer, colorectal cancer and others. Martinsried, Germany-based GPC still considers satraplatin a Phase II asset very much worth partnering, CEO Bernd R. Seizinger said during an Oct. 31 conference call.

GPC is partnered on the candidate with Boulder, Colo.-based Pharmion in Europe, where Pharmion has filed a marketing application for satraplatin that it had intended to supplement with results from the Phase III SPARC study. "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 [European Medicines Agency]," Pharmion CEO Patrick J. Mahaffy said in a statement.

In June, GPC licensed the oncologic to Yakult Honsha for development in Japan.

GPC completed a rolling NDA for satraplatin in second-line HRPC in February under a special protocol assessment with FDA that specified a progression-free survival endpoint. The firm withdrew the NDA after FDA's Oncologic Drugs Advisory Committee advised in July that it should be based on the overall survival endpoint (¹ [A#14070730008]).

GPC had planned to resubmit the NDA based on the overall survival data. In August, the firm announced it would put two preclinical programs on hold and cut 15 percent of its U.S. workforce to reserve funds while awaiting those results (² Also see "GPC Retrenches While Awaiting Satraplatin Data" - Pink Sheet, 24 August, 2007.).

The SPARC trial enrolled 950 HRPC patients and randomized them to receive satraplatin plus prednisone or placebo plus prednisone. The median survival was 61.3 weeks for the satraplatin arm compared to 61.4 weeks for the control group, with a hazard ratio of 0.97 (95 percent CI: 0.83, 1.13).

-Shirley Haley (s.haley@elsevier.com)

GPC Biotech’s Satraplatin Fails To Meet Survival Endpoint In SPARC Trial

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