Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘Prostate Cancer Landscape’

Lemons Villa BorgheseThe discovery of a novel target in castration-resistant prostate cancer (CRPC) and the potential of drugs targeting this to delay or overcome adaptive resistance is the subject of today’s post.

Followers of the prostate cancer field know that one of the challenges with drugs such as enzalutamide and abiraterone is that patients stop responding to them over time and they develop acquired resistance.

So imagine that you could give a drug that is not only an effective anti-cancer agent in patients with acquired resistance, but might then allow those treatments to be effective a second time around.  A recently identified druggable target means this is now a possibility.

Of course, it’s early days yet, and the preclinical work has yet to translate into humans, but it’s not hard to see the commercial implications in the prostate cancer landscape for companies such as $MDVN, $JNJ, $TKAI, Bayer and anybody else who wants to be a player.

Interested? Subscribers can login to read more or you can purchase access below. This post is Day 3 in our Road to AACR 2016 series.

EAU 2015 LogoMadrid, 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).

Professor Dr. med. Axel Heidenreich. Credit: Universitätsklinikum Aachen

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.

Subscribers can login to read the full interview or you can purchase access by clicking on the blue Tinypass icon at the bottom of the page.

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

Prof Arnauld Villers presents TERRAIN trial data at AUA 2015

Marching Band Changing Guard LondonToday marks a year since we put up a paywall on Biotech Strategy Blog. While we were sorry to have to restrict access in this way, our decision reflects what is happening in the wider digital media arena, it’s simply not possible to go to conferences and generate quality content for free!

It was Warren Buffett who said, “Price is what you pay, value is what you get” and that’s how we feel about charging for access to Premium Content on the blog.

When we put a paywall up on the blog last September, many thought it would not last. All those who bet on its early demise are still waiting 😉

What the paywall has done is create an exclusive club that have access to our insights and analysis. Other traditional media organizations are now following suit, by charging a membership fee for premium access.

There is a wealth of free data on the Internet, and lots of media folk do a good job of sharing or curating this, but raw data is not intelligence, nor do they tell you anything about context or meaning. Insights also require knowledge, expertise and thought to generate.

Journalism and digital media are going through a revolution as those who create original content seek to get paid for it. We are part of that vanguard. So this post is a big thank you for all our subscribers from around the world who have supported our initiative.

Our thanks also to Tinypass, who as our technology partner, creates the paywall and administers the payment processing system. We could not have achieved the success we have had without them.

Year in Review:

Looking back at this year, we’ve covered remotely or on site 10 conferences or scientific meetings:

  • ECCO 2013 (Amsterdam)
  • AACR-EORTC-NCI Molecular Targets (Boston)
  • World Lung (Sydney)
  • ASH 2013 (New Orleans)
  • SABCS (San Antonio)
  • JPM 2014 (San Francisco)
  • ASCO GI (San Franciscso)
  • ASCO GU (San Francisco)
  • Miami Breast
  • AACR 2014 (San Diego)
  • AUA 2014 (Orlando)
  • ASCO 2014 (Chicago)

Funding from our subscribers enabled us to attend most of these meetings in person. In addition we’ve followed interesting new stories e.g. by going to Paris to interview the senior management of Cellectis about their CAR-T cell therapy.

By my calculation we’ve written approximately 120 premium content posts of the past year, so the cost per post at the current annual rate is about $10. Those who signed up for special offers got them for even less.

So thanks to everyone who has supported us over the past year, we greatly appreciate you being part of the journey with us. We look forward to welcoming new subscribers over the coming year.

For a limited time only (until end of October) we are offering a special anniversary offer where you can lock in your rate for 2 years. Just click on any post and scroll down to sign up in the box under the post.

Check it out!



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.

armor-logoAt 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?

The 102nd Annual meeting of the American Association for Cancer Research (AACR) ended yesterday in Orlando, and it was only the diehards who kept going till the last session of the last day for an update on “Novel Androgen Receptor Antagonists.”

As I mentioned in an earlier post, there is a lot of excitement in the prostate cancer field at the moment with three new therapies approved last year (cabazitaxel, sipuleucel-T, denosumab), and more expected over the next two years (abiraterone acetate, MDV3100, cabozantinib/XL-184).

What I took from the AACR session I attended, is that there are also other products in the pipeline that are worth watching.  Below is a list of some of the products that were mentioned. It’s not intended to be a comprehensive review of the prostate cancer landscape, only my notes and thoughts on some of the new products that the speakers touched upon.

Abiraterone Acetate: The postive phase III trial results were reported last year at ESMO and ASCO GU, and the approval of this drug is currently being considered by the FDA.  Approval is expected shortly, and possibly in time for launch at the forthcoming annual meeting of the American Urological Association (AUA) meeting in Washington, DC.

Abiraterone (brand name Zytiga) inhibits the enzymes (17-alpha hydroxylase and C17, 20 lyase) responsible for adrenal androgen formation.

The phase III results were impressive in very sick patients who were close to the end of their lives in very advanced disease.  Overall survival increased from 10.9 to 14.8 months in the second line chemotherapy setting post docetaxel.  It’s expected that the results will be more dramatic pre-chemotherapy.

Once the FDA approval is obtained, it’s hard to see how oncologists will not consider abiraterone instead of cabazitaxel in the second-line chemotherapy setting.  An easily taken pill with fewer less side effects may be a more convenient option for elderly or frail men with prostate cancer.  Abiraterone’s approval will not be good news for sanofi-aventis.

I also expect we will see significantly off-label usage of abiraterone pre-chemotherapy by urologists as they seek to maintain hormone-sensitivity in their patients after several lines of anti-hormonal therapies.  There is a phase III trial ongoing in this setting that is expected to show promising data by the end of the year.

However, it’s a good strategy to come market as soon as possible to provide wider access to patients in need, and the post-docetaxel second line setting allowed the overall survival benefit to be shown before the pre-chemo data would be available.

However, what I learned at the meeting is that abiraterone acetate may not be the best product in the long term.  Currently it requires the corticosteroid, prednisone, to be given at the same time to attenuate the mineralocorticoid effects.  Questions that were raised in the AACR session about long-term treatment with abiraterone included, “Must a corticosteroid be given concurrently?” and “What about hypertension?”

Other questions remain, such as possible development of resistance to abiraterone. Often the first drug to market is not the best, and it’s possible that second generation new products in the pipeline may be better than abiraterone and delay the time to resistance further.

However, what abiraterone does have is first mover advantage and depending on the pricing strategy adopted by Johnson & Johnson, the ability to capture market share earlier.  It will be interesting to see what happens with this drug, but it’s certainly an exciting time for patients with prostate cancer.

TAK-700: This drug from Takeda/Millennium is a more potent inhibitor of C17α-hydroxylase than abiraterone.  One of the panelists at AACR believed that TAK-700 “may in the long run surplant abiraterone acetate due to less need for mineralocorticoids.” TAK 700 entered phase III clinical trials late last year.

MDV3100:  This drug is being developed by Medivation/Astellas and is also in phase III trials, with data expected by the end of this year or early 2012.  It has a high affinity for the androgen receptor. However, what came across in the AACR presentation by Howard Scher, was his view that the second compound developed by Charles Sawyers, ARN-509 may be better than MDV3100.

ARN-509: This drug from Aragon Pharmaceuticals is in phase I/II clinical trials and is definitely one to watch.  As Dr Scher pointed out, ARN-509 is more potent than MDV3100 and I expect we will see publication of more data on ARN-509 in the near future.

If you are interested in prostate cancer, AACR are offering webcasts and podcasts of scientific sessions this year.  Further information can be found on their website.  AACR have also announced a scientific special session on “Advances in Prostate Cancer Research” from February 6-9 2012.  It’s certainly an interesting and exciting time in this field as new products become available, something that is likely to make a real difference to how this disease is treated.


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