Prostate

Cancer                                        
XTANDI Demonstrates Significant Improvement in
Title Overall Survival in Phase 3 PROSPER Trial of
Patients with nmCRPC.  
Astellas announced today results of the final overall survival (OS) analysis from the
Phase 3 PROSPER trial, which evaluated XTANDI plus androgen deprivation therapy
(ADT) versus placebo plus ADT in men with non-metastatic castration-resistant
Details
prostate cancer (nmCRPC). The results demonstrated a statistically significant
improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT.
OS was a key secondary endpoint of the trial.
Improved OS data will reinforce the data of primary endpoint
Prescienc
e
MFS of 3 years vs 14.7 months with placebo. This strenthens the
market position of Xtandi.  
Astellas - Press
Source Release, February
11, 2020                              

Prostate
                                       
Cancer

Trovagene Presents Phase 2 Data Demonstrating the Ability of Onvansertib to

Title
Overcome Zytiga®-Resistance and Provide Clinical Benefit for mCRPC Patients

Trovagene announced positive data from its ongoing Phase 2 trial of onvansertib in
combination with Zytiga® (abiraterone – Johnson & Johnson)/prednisone, all
administered orally, for the treatment of patients with Zytiga®-resistant metastatic
castration-resistant prostate cancer (mCRPC). The clinical data presented in ASCO
Details GU 2020 demonstrates the efficacy of onvansertib in patients who develop resistance
to first-line treatment with Zytiga. Onvansertib addresses Zytiga resistance across
known androgen receptor (AR) resistance mechanisms. In patients with AR
alterations, 86% had decreases in PSA levels with the addition of onvansertib to daily
Zytiga.

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine

triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1
Prescienc
(PLK1) enzyme. With efficacy signals seen in zytiga resistant patients, Onvansertib
e
demonstrates  potential to deliver effiacy in mCRPC patients progressing on AR
inhibitors such as Xtandi and Erleada as well.

Source Trovagene - Press release, February 13, 2020

Prostate Cancer

Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with
non-metastatic castration-resistant prostate cancer who are at high risk of developing
metastatic disease.

The positive CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy
and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo
plus ADT, which demonstrated a highly significant improvement in primary efficacy
endpoint of metastasis-free survival (MFS) of darolutamide plus ADT. The final decision
from the European Commission is still awaited
Darolutamide offers another choice of AR inhibitor for high risk non-metastatic prostate
cancer patients. The efficacy of darolutamide is comparable to currently available AR
inhibitors in similar patient settings. The drug is already approved in the US, Brazil and
Japan and filings in other regions are underway or planned.

Bayer - Press Release, January 31, 2020