Strong Zytiga study results could increase uptake
pharmafile | March 12, 2012 | News story | Research and Development, Sales and Marketing | IDMC, Janssen, Provenge, Zytiga, prostate
Janssen’s prostate cancer pill Zytiga could be on course to target a larger number of patients following a positive late-stage trial.
The Phase III study was looking at Zytiga (abiraterone acetate) in patients who have not had chemotherapy after trial results suggested the drug may increase their chances of survival.
The drug is currently approved in Europe as a second-line treatment with steroid prednisone for metastatic castration-resistant prostate cancer (mCRPC), in men whose disease has progressed after chemotherapy.
A new indication – which the manufacturer says will be submitted for approval in the US and elsewhere in the second half of the year – would be a significant boost for the drug.
It would pit Zytiga against Dendreon’s novel cancer vaccine Provenge, which already has a first-line licence in the US for asymptomatic or minimally symptomatic mCRPC.
Analysts have already suggested that oncologists are likely to prescribe Zytiga more than Provenge because it is easier to administer.
While it does not have the green light from NICE, Zytiga is one of the most commonly approved treatments to be accessed via the government’s Cancer Drugs Fund.
COU-AA-302 is an international, randomised, double-blind, placebo controlled study assessing Zytiga plus prednisone for asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.
More than 1,000 patients received Zytiga 1,000mg once daily, plus prednisone 5 mg twice daily or placebo plus prednisone 5mg twice a day.
The Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the study after an interim analysis observed clinically beneficial differences in radiographic progression-free survival, overall survival and secondary endpoints.
The IDMC said patients in the placebo arm should now be offered treatment with Zytiga.
“The COU-AA-302 study has been a key priority for us as we expand our understanding of the utility of Zytiga in metastatic prostate cancer,” said William Hait, global head of Janssen R&D.
The Phase III study for Zytiga’s current indication was also unblinded at the interim point in August 2010.
Adam Hill
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