At the recent ASCO 2016 Genitourinary Cancers Symposium (ASCO GU) that took place in San Francisco the week before the JP Morgan Healthcare Conference (JPM), one of the noteworthy presentations was on a novel target for men with advanced prostate cancer.
While JPM may have been a “dud” for many, several companies did take the opportunity to update and discuss their corporate strategy going into 2016, which gave a surprising amount to comment on in our 3 blog posts from the meeting: JPM Day 1, JPM Day 2, JPM Day 3.
In this post we look at the “take homes” from the ASCO GU presentation, and what looks like it could be a new race to market.
It’s good to see novel targets for men with advanced prostate cancer, and potential new treatment options on the horizon!
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New Orleans – in today’s plenary session at the 2015 annual meeting of the American Urological Association (Twitter: #AUA15), Dr Celestia Higano (Seattle), presented the results of the STRIVE trial (NCT01664923) – a multicenter phase 2 study of enzalutamide (Xtandi) versus bicalutamide in men with nonmetastatic (M0) or metastatic castration-resistant prostate cancer (M1). These were men who were asymptomatic or mildly symptomatic.
Dr Higano noted that this was a very late breaking abstract; topline results were only announced a little over a month ago on April 2.
The TERRAIN trial also compared the efficacy of enzalutamide head-to-head against bicalutamide. We’ve updated our EAU 2015 TERRAIN post with the additional data presented here at AUA 2015 in New Orleans.
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Madrid, Spain – the results of the Medivation/Astellas TERRAIN clinical trial of enzalutamide (Xtandi) versus bicalutamide (Casodex) in men with metastatic castration resistant prostate cancer (mCRPC) were presented today at the European Association of Urology Congress in Madrid (Twitter #EAU15).
Credit: Universitätsklinikum Aachen
The clinical trial data were presented in a plenary session at EAU15 by Axel Heidenreich (pictured left) who is Professor of Urology & Uro-oncology at the RWTH University and Head of Department & Director of the Urology Program at the University Hospital in Aachen, Germany.
How good are the results, and what impact will they have on the prostate cancer treatment landscape in Europe? Prof Heidenreich kindly spoke with Biotech Strategy Blog (BSB) and shared his thoughts.
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Update May 17, 2015: This post has been updated with the additional TERRAIN trial data presented by Professor Arnauld Villers (Lille) at the 2015 annual meeting of the American Urological Association (AUA) in New Orleans.
Prof Arnauld Villers presents TERRAIN trial data at AUA 2015
Yesterday saw the news that Tokai Pharmaceuticals ($TKAI) have filed plans for a $75M IPO, largely based on the potential of their phase 2 prostate cancer compound, galeterone.
My first reaction on seeing this was $75M – that’s a pretty small number.
It’s been many years since I project managed drug development trials but $75M does not go a long way if you want to run a global phase 3 program. It’s certainly pails into insignificance in comparison to the recent $308M raised by Juno in Series A & B financing.
A cynical view would be to see this as the initial investors looking for a ‘save face’ exit strategy. Tokai have spent the last 10 years seeking to bring a novel prostate cancer drug to market, and they are still only in phase 2. To put this in perspective, they were initially ahead of Medivation!
Fast forward 10 years and the prostate market is now highly competitive, with other new products ahead of galeterone in development including next generation androgen receptor antagonists: ARN-509 (acquired by JNJ from Aragon) and ODM-201 (Bayer/Orion). We’ve also seen a several drugs that showed promise in phase 2, fall by the way side in phase 3; dasatinib from BMS and Orteronel (TAK-700) from Takeda/Millennium readily come to mind. Caveat emptor!
At ASCO 2014, there was a lot of interesting data in the oral prostate cancer session, which provided insights into the challenges (in addition to the competition) and opportunities that may exist for galeterone.
I have no intention of taking any future position in $TKAI. This piece offers no recommendation on whether you should invest or not.
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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!
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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?
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The share price of Exelixis ($EXEL) is starting a run-up (after months in the doldrums) in advance of anticipated results from the COMET-1 phase 3 trial in metastatic castrate resistant prostate cancer (mCRPC) for cabozantinib (Cometriq, formerly XL184).
Cabozantinib is a small molecule tyrosine kinase inhibitor of c-Met and VEGFR2. It has been shown to significantly improve bone scans and decrease pain, but the $64,000 questions are will patients taking it live longer and feel better?
The answers will come from the COMET-1 trial that has a primary end point of overall survival (OS). It’s a placebo-controlled trial of 960 men with advanced prostate cancer randomly assigned to cabozantinib 60mg (n=640) or prednisone (5mg twice daily) (NCT01605227) who have disease progression after treatment with docetaxel chemotherapy and abiraterone (Zytiga) or enzalutamide (Xtandi).
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Update Sep 1, 2014 COMET-1 is a failure
We normally put updates at the end of a post, but we’ve just heard the trial a failure, so I think it’s appropriate to put this upfront. Am glad that our analysis turned out to be correct. Congratulations to those blog subscribers who on the basis of this post sold all or part of their $EXEL position. Commiserations if you held on.
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).
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Amsterdam – Earlier today, I had the great pleasure at the European Cancer Congress to interview Oliver Sartor, MD, the Piltz Professor of Cancer Research in the medicine and urology departments of Tulane School of Medicine in New Orleans, LA.
A recognized expert in prostate cancer, Dr Sartor was gracious enough to give me an impromptu interview in the poster hall at ECCO 2013 and share his thoughts about the prostate cancer clinical data presented in Amsterdam.