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news.An independent data monitoring board has recommended that GPC Biotech's phase III registrational prostate cancer trial, SPARC, continue through to completion as planned.
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The data monitoring board (DMB) analyzed the efficacy data as assessed by the blinded independent progression review panel on the first 354 progression-free survival (PFS) events and also reviewed the safety data from the first 593 patients who had been randomized in the trial and had completed at least one cycle of satraplatin treatment.
After reviewing the data, the DMB reported that the design and conduct of the trial remained sound. In addition, the DMB determined that the SPARC trial had also passed the pre-defined futility analysis.
GPC Biotech anticipates reporting final PFS results from the trial this autumn and, providing these results are positive, expects to complete its new drug application (NDA) filing with the FDA by the end of the year.
Additional clinical trials in other oncology indications and with satraplatin in combination with other anticancer agents are also ongoing.