According to a media release issued by Bayer a couple of days ago, the combination of androgen deprivation therapy (ADT) + darolutamide (Nubeqa) extends overall survival “significantly” in men with non-metastatic, castration-resistant prostate cancer (nmCRPC).
The company states that the data supporting this finding will be “presented at an upcoming scientific meeting.” That meeting will apparently be the immediately upcoming Genitourinary Cancer Symposium (later this month in San Francisco). We’ll need to wait and see to get the details.
Nubeqa is currently approved by the US Food and Drug Administration for the treatment of men with nmCRPC based on its ability to extend metastasis-free survival (MFS) in the Phase III ARAMIS trial. In that trial, the combination of ADT + darolutamide extended MFS by 21.6 months — from a median MFS of 18.4 months for men treated with a placebo + ADT to a median of 40.4 months for men treated with darolutamide + ADT. The data showing a significant improvement in overall survival time also comes from the Phase III ARAMIS trial after longer patient follow-up.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: castration-resistant, darolutamide, nmCRPC, non-metastatic, overall, survival |
THE "NEW" PROSTATE CANCER INFOLINK 
Doesn’t it seem odd that Bayer’s press release would state that there was a significant difference in OS, yet they don’t give any information at all as to just how significant that difference was? What was the “p” value? What was the Hazard Ratio?
Dear Len:
The reason that the media release does not include the detailed information you refer to is because scientific and medial publication guidelines do not allow for these sorts of details to be first announced outside of a peer-reviewed setting. These details will be a key part of what is presented at the upcoming meeting, and it is possible that the full data will also be published very soon thereafter.
The type pf media release issued by Bayer is far from uncommon because the existence of data like this could affect a company’s valuation on the stock market, and so it is a compromise whereby the company is able to state that the data are “coming soo”n without actually stating the full details of the data.