Pfizer Inc.PFE and its Japanese partner Astellas Pharma announced that a phase III study - ARCHES - evaluating prostate cancer drug, Xtandi (enzalutamide), met its primary endpoint. The study was evaluating the drug in combination with androgen deprivation therapy ("ADT") as a treatment for metastatic hormone-sensitive prostate cancer (mHSPC).
Data showed that the Xtandi combination therapy significantly improved radiographic progression-free survival (rPFS), the primary endpoint, in the expanded patient population compared to ADT therapy alone. The safety profile of the drug was consistent with previously observed profiles in clinical studies evaluating it in castration-resistant prostate cancer ("CRPC"). A detailed data will be presented at an upcoming medical congress.
Notably, Xtandi is already approved as a treatment for metastatic and non-metastatic CRPC in the United States. A potential approval based on the above-mentioned data in mHSPC patients will expand the patient population to include men with prostate cancer that has progressed outside the prostate gland but still responds to treatment to lower testosterone.
Pfizer's efforts to expand the label of the drug in new cancer patient population are commendable. Currently, the company is evaluating Xtandi in another late-stage study - EMBARK - in hormone-sensitive prostate cancer as well as mid-stage studies for advanced breast cancer and hepatocellular carcinoma.
So far this year, shares of Pfizer have gained 15.8% compared with the industry 's 1.5% growth.
In a separate press release, the company announced that it is discontinuing the phase IIb STRIVE study evaluating its Staphylococcus aureus (S. aureus) multi-antigen vaccine candidate, PF-06290510. The decision was based on recommendation from an independent Data Monitoring Committee, following a planned interim analysis.
Based on the data from STRIVE data, the committee concluded that there is a low statistical probability of successful completion of a phase III study on the candidate. At present, Pfizer is evaluating steps for potential future development of any S. aureus vaccine.
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