Prostate Cancer: Update Bulletin [January 2018]
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:
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?
