Investigational Cancer Drug Fails Trial
GPC Biotech’s investigational cancer treatment satraplatin failed to show a survival benefit in patients with hormone-refractory prostate cancer in a Phase III clinical study testing the product in the second-line treatment setting.
As a result of the negative trial data, the company will reevaluate continued enrollment in its satraplatin expanded-use program.
The results are a major setback for the firm as satraplatin is GPC Biotech’s only late-stage drug candidate. Data on the cancer agent’s effect on survival were pivotal for the drug’s approval prospects in the U.S.
The company withdrew its new drug application (NDA) after the FDA’s Oncologic Drugs Advisory Committee recommended in July that the agency defer its decision on the application until the company submitted survival data.
The original NDA was based on progression-free survival with secondary endpoints of time-to-pain progression and interim analyses on overall survival. When the application was withdrawn, the company said it would resubmit it upon receipt of positive survival data.
Bernd Seizinger, CEO of GPC Biotech, said during an Oct. 31 conference call that the firm still plans to meet with the FDA to discuss the results of the trial. Although further subset analyses of the data will be conducted, it is unlikely the company can secure approval based on such analyses, he added.
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