Results

Xtandi fails a combo study, blocking a path to continued use for Pfizer, Astellas

One of the studies on the prostate cancer drug Xtandi that Pfizer inherited in its $14 billion buyout of Medivation has failed to deliver.

The pharma giant and its partners at Astellas say that Xtandi combined with J&J’s rival Zytiga and the steroid prednisone failed to bend the curve on progression-free survival for chemo-naive patients whose disease had progressed following treatment with Xtandi, compared with a group of patients treated with Zytiga and prednisone alone. The investigators had been looking for a rationale to continue treatment with Xtandi, which would have expanded its blockbuster market even further.

Several analysts have been following the trial as a catalyst for longer treatment duration of Xtandi, a potentially valuable add to its owners. But now that Pfizer acquired the drug, for castration-resistant prostate cancer, analysts haven’t been watching this one as closely as before.

Pfizer, though, could definitely use a bigger market for this drug after paying top price for a share of the drug.

“While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances,” said Mohammad Hirmand, MD, interim chief medical officer at Medivation. “We will continue to analyze these data to better understand the results with the goal of further helping these patients.”


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RAPS Regulatory Convergence 2017