Since 2004, six new prostate cancer treatments have been approved for advanced prostate cancer: docetaxel (Taxotere), sipuleucel-T (Provenge), cabazitaxel (Jevtana), abiraterone (Zytiga), enzalutamide (Xtandi), radium-223 (Xofigo).
In the process, the competitive landscape has been radically transformed.
What we have seen more recently with the PREVAIL and COU-AA-302 data is a move to treat mildly symptomatic men earlier in metastatic disease prior to chemotherapy, thereby delaying disease progression, and in the case of enzalutamide, improving overall survival.
But how early can you go?
The focus of several companies looking to bring new prostate cancer drugs to market is now shifting from symptomatic metastatic castrate resistant prostate cancer (mCRPC) to earlier in the disease setting, i.e. asymptomatic M0 disease.
There are number of critical questions that need addressing, including:
- Should we treat men with metastatic (M0) castration-resistant prostate cancer (CRPC) who are asymptomatic?
- Will the treatments be able to demonstrate that taking them means men will live longer and feel better?
- Will there be a market for AR antagonists such as enzalutamide, ODM-201, and ARN-509 in M0 prostate cancer, where large randomised phase 3 trials are either underway or are planned?
Prof Tombal at ASCO GU 2013
During ASCO GU, I asked one of the leading thought leaders and researchers into this area for his candid perspective.
Subscribers to Premium Content can sign in or sign up in the box below to read what Professor Bertrand Tombal had to say on this topic – his answers may well surprise you.
San Francisco – In the ASCO GU prostate cancer session yesterday morning one of the most interesting presentations was by Andrew J Armstrong, Associate Professor of Medicine and Surgery at the Duke Cancer Institute.
I previously referenced Dr Armstrong’s excellent education presentation at ASCO 2012 in my piece on Xconomy about the emerging challenges of prostate cancer drug development.
He’s a speaker that I particularly enjoy listening to, so my attention was immediately drawn to his presentation at ASCO GU on, “Beyond Enzalutamide and Abiraterone: What’s Next in Androgen Therapy.”
Looking at this title, at first glance the question that comes to mind is do we really need new treatments that target the Androgen Receptor (AR), after all we’ve heard this week about the PREVAIL trial with enzalutamide?
Based on Dr Armstrong’s presentation the answer is a resounding yes!
Subscribers to Premium Content can login to read more below:
San Francisco – Tokai Pharmaceuticals is a case study in how not to do drug development.
A company, founded in 2004, with a novel prostate cancer drug has taken 10 years to make it to phase II drug development while competitors such as Medivation and Johnson & Johnson have brought similar new drugs to market in multiple prostate cancer indications.
At ASCO GU this week (Abstract 71), Tokai reported part 1 of their phase 2 ARMOR2 trial with reformulated galeterone (TOK-001) in men with prostate cancer at various stages of the disease in a poster. Part 2 of the study will enrol 136 patients with a once daily dose of 2550 mg.
Subscribers to Premium Content can read below an analysis of some of the challenges that Tokai Pharmaceuticals faces, which raise the question of whether galeterone will in fact make it to market?
This week sees the start of the American Society of Clinical Oncology Symposium on Genitourinary Cancers (ASCO GU) in San Francisco.
Prostate cancer has certainly been in the minds of investors the past few weeks in anticipation of the COMET-1 prostate cancer trial results for cabozantinib (Cometriq).
The share price went on a run-up until Exelixis CEO Michael Morrissey took yet another trip to the biotech ATM machine. Somehow, this doesn’t come as any surprise given past performance. The key issue at stake here, however, is will the COMET-1 trial be positive or negative? The outcome is much anticipated and will no doubt influence the chances of successful approval for cabozantinib in advanced prostate cancer. Data is expected sometime in first half of this year.
What we can expect in the media this week is more news on the Medivation and Astellas phase 3 trial PREVAIL clinical trial of enzalutamide (Xtandi) in men with advanced prostate cancer who had not yet received chemotherapy. The ASCO GU abstracts are publicly available at 5pm on Tuesday.
Currently, the key data from oncology medical conferences is focused squarely on Medivation’s enzalutamide and the PREVAIL data. It seems a good idea to discuss what are the key things to watch out for?
You can sign in or sign-up below to read the report.
As 2013 comes to an end, rather than look back as many are doing, I’m looking forward to 2014. January is a busy month for cancer meetings with the ASCO organized gastrointestinal cancers symposium (ASCO GI) and genitourinary cancers symposium (ASCO GU) both taking place in San Francisco a few weeks apart.
In fact, looking at the calendar of forthcomings meetings, 2014 looks to have a West Coast focus, with the annual meeting of the American Association for Cancer Research (AACR) taking place in San Diego in April, and the American Society of Hematology (ASH) annual meeting also heading to San Francisco in December.
Transcontinental airfares are notoriously expensive at the last minute so if flying from the East Coast, do make travel plans early!
The ASCO GU symposium takes place at the San Francisco Marriott Marquis from Jan 20 – February 1, 2014. The abstracts for meeting go online at 5pm Eastern Time on Jan 28.
ASCO in a December 19 press release have already announced what will be highlighted on the January 28 press cast, and what many of the media can be anticipated to write about from the meeting.
Perhaps not surprisingly the Medivation PREVAIL trial data (LBA1) is top of the list; the abstract for this presentation has already been published online as Professor Tombal (@BertrandTOMBAL) kindly highlighted on Twitter.
This preview highlights some of the prostate cancer abstracts and presentations to watch out for at the meeting:
Drugs discussed in this post include: enzalutamide (Xtandi), abiraterone (Zytiga), ODM-201, ARN-509, ipilimumab (Yervoy).
Subscribers to premium content can login and read the ASCO GU 2014 prostate cancer preview below: