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Prostate Cancer: Update Bulletin [January 2018]

Introduction

This edition presents key opinion leader (KOL) views on recent developments in the prostate cancer market. Topics covered include: Pfizer and Astellas’ announcement in September 2017 that the Phase III PROSPER study evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS); the European Commission’s extended approval for Johnson & Johnson’s (J&J’s) Zytiga (abiraterone acetate) to include treatment of patients with newly diagnosed, high-risk, metastatic hormone-sensitive prostate cancer (mHSPC); Bavarian Nordic’s announcement that it was discontinuing the Phase III PROSPECT study of the PSA-targeted immunotherapy candidate PROSTVAC (rilimogene galvacirepvec) in patients with metastatic CRPC (mCRPC); Bayer’s announcement in December 2017 that it will unblind early the ERA223 Phase III study that is investigating Xofigo (radium-223 dichloride) in combination with J&J's Zytiga in patients with prostate cancer as a result of an imbalance of more fractures and deaths in patients receiving the combination.

Business Questions:

What are the expert’s opinions on the Phase III PROSPER study design with Xtandi?

Do the KOLs anticipate any change in the treatment of non-metastatic CRPC patients based on the results of the PROSPER study?

What do KOLs think regarding the European Commission’s expansion of Zytiga’s label to include patients with mHSPC?

Will the European approval and pending FDA approval for Zytiga change the treatment landscape for patients with mHSPC and mHNPC, respectively?

What are KOLs’ reactions to Bavarian Nordic’s discontinuing the Phase III PROSPECT trial for PROSTVAC?

Do the experts see a future for PROSTVAC as a treatment for prostate cancer?

What are the experts’ reactions to the news that Bayer will unblind early the ERA223 Phase III study investigating the combination of Xofigo with Zytiga?

What do KOLs believe has been the cause of the increased risk of fractures with the combination?

Do the KOLs envisage any future opportunity to use Xofigo in combination with Zytiga or Xtandi in earlier treatment settings?


Please Note: Due to the brevity and/or nature of the content posted, there is no table of contents available for this report.

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