Biotech Strategy Blog

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

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ESMO 2014 Bladder CancerCancer immunotherapy, the ability to harness the body’s own immune system to fight cancer, is showing early promise in bladder cancer.

“Breathing new life into bladder cancer treatment” was the title of the excellent discussion by Maria De Dantis (Vienna) of data presented at the recent ESMO Congress in Madrid.

Advanced bladder cancer has a particularly poor prognosis. Once the cancer has spread in the body, according to Cancer Research UK, the average survival time is approximately a year to 18 months.

There is clearly an unmet medical need for effective new treatments, with no major treatment advances for over 30 years. To date, targeted agents in the second-line setting have shown only incremental progression free survival and generally low overall response rates.

Which is why it’s exciting to see hope for patients with urothelial bladder cancer from new inhibitors of the PD-1 immune checkpoint signalling pathway.

At ASCO this year, data for Roche/Genentech’s anti PD-L1 (MPDL3280A) was presented (Abstract 5011) by Thomas Powles (Barts, London). Commenting on the data, in her post “Making a difference in advanced bladder cancer” Sally noted, “it wouldn’t have been out of place in the Plenary session, frankly.”

Recognizing the potential based on the promise of the early clinical data, on May 31st the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to MPDL3280A in bladder cancer.

ESMO 2014 Bladder Cancer Session ChairsIf you need to catch up on immuno-oncology, we have a growing library of posts on Biotech Strategy Blog, and we’ll be continuing our coverage of the rapid progress in this area at the forthcoming annual meeting of the Society for Immunotherapy of Cancer (SITC), which takes place at National Harbor, MD from Nov 6 -9.

At ESMO 2014, phase 1 clinical trial data in bladder cancer was presented for both Pembrolizumab (Merck) and MPDL3280A (Roche/Genentech).

Subscribers can login in to read how the two drugs compared in this indication, or you can purchase access by clicking on the blue icon below.

We spend a lot of time in the poster halls at scientific and medical meetings such as European Society for Medical Oncology (ESMO) Congress in Madrid because that’s where the action is in terms of finding nuggets of promising preclinical and early clinical data. You can also spot new trends emerging earlier this way.

ESMO 2014 Poster Hall

At large meetings run by the American Society of Hematology (ASH) and American Association for Research (AACR) there are literally thousands of posters, all of which have passed the grade to merit presentation.

Gaining insights from posters, and in particular, picking those that really matter is often an art rather than a science – a lot of intuition is involved.

This post discusses a few of the posters presented in the developmental therapeutic session at ESMO this year. It focuses on non-immunotherapy topics, i.e. traditional TKIs and monoclonal antibodies to specific mutations or other targets.

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One of the sessions that stood out for me at the recent European Society for Medical Oncology (ESMO) Congress in Madrid was a Special Symposium on “Advances in Precision Medicine of Metastatic Colorectal Cancer.”

Federica Di Nicolantonio ESMO 2014This blog post focuses on two presentations in the symposium:

  • “Emerging druggable targets in colorectal Cancer” by Federica Di Nicolantonio (Candiolo Cancer Institute, University of Torino, Italy).
  • “Signal Transduction Inhibitors and Pipeline Drugs” by Josep Tabernero MD PhD (Vall d’Hebron University Hospital, Barcelona)

Dr Nicolantonio, pictured right, is active on Twitter (@fdinicolantonio) and well worth a follow!

Since the advent of VEGF (Avastin) and EGFR (Erbitux) inhibitors way back in 2004, there haven’t been any new developments in this cancer type other than more of the same (Zaltrap and Vectibix, respectively), so I was particularly excited to see progress in colorectal cancer, and the promise of new drug targets on the horizon that may change the treatment landscape.

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At the 2014 ESMO Congress in Madrid, Mary-Ellen Taplin, MD (Dana-Farber Cancer Institute, Boston) presented the results of the Tokai Pharmaceuticals (NASDAQ $TKAI) ARMOR2 clinical trial of galeterone in men with advanced prostate cancer.

ESMO 2014 Dr Taplin Galeterone ARMOR2 Presentation

Galeterone has a novel triple mechanism of action. In effect, it is a CYP17 lyase inhibitor (like abiraterone) that has additional anti-prostate cancer actions including androgen receptor (AR) inhibition (like enzalutamide). It also causes AR degradation that decreases AR levels.

Tokai’s IPO last month is reported by Renaissance Capital to have raised $98M for the company, with most of the funds going to prior investors including Novartis Bioventures which owned 28 percent.

Shares in $TKAI were initially priced at $15. They soared to a high of $30 thanks to high insider buying and a high trading volume. Novartis Bioventures were reported by Renaissance to have bought $20M.

As of publishing this post, the stock is now trading at $15.40, slightly above it’s IPO price. So have Novartis and others made a good investment?

Tokai Pharmaceuticals Stock Info Oct 3, 2014The market cap of $TKAI, according to their Investor Relations page (screenshot pre-market Oct 3, 2014 shown above) is $336M – not high for a company about to enter phase III drug development.

Readers are no doubt aware of the Feuerstein-Ratain rule that predicts a phase III cancer trial will be a failure when undertaken by a company with a market cap less than $300M. As Adam noted in his May 6 story on The Street earlier this year, “For companies with market caps between $300 million and $1 billion, the oncology phase III success rate is 59%.

The big questions now are did the data for galeterone from the ARMOR2 trial impress at ESMO 2014 in Madrid and what are the challenges and opportunities in the planned phase III ARMOR3-SV trial? 

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DISCLAIMER: Please note this piece offers no stock advice, is not a solicitation to invest in $TKAI and makes no recommendation on whether to buy or sell. It merely offers commentary and analysis of the data presented at ESMO 2014. Readers should do their own due diligence prior to making any investment decision.


Dr Sandra Swain ESMO 2014 Cleopatra PresentationMadrid – it’s Day 3 of ESMO 2014 (#ESMO14), the annual Congress of the European Society for Medical Oncology, and the last day when we will be publishing a live blog from the meeting.

As predicted in our plenary preview, the highlight of the Congress is the overall survival data for the CLEOPATRA trial in HER2+ metastatic breast cancer where the addition of pertuzumab (Perjeta) to trastuzumab (Herceptin) and docetaxel chemotherapy resulted in an additional survival benefit of almost 16 months.

As Dr Sandra Swain noted in her presentation of the data in yesterday’s Presidential Symposium: “the 56.5 month median OS is unprecedented in this indication.”

Note that says MONTHS (almost 5 years) not weeks – it represents the new standard of care that all women with metastatic HER2+ breast cancer should now receive.

The prolonged applause at yesterday’s packed plenary session at ESMO 2014 summed up the feelings felt at hearing this practice changing data; the audience of medical oncologists live for moments like this! It’s truly the sort of stuff that makes you smile and go “Wow.”  We will be writing more about the commercial implications of the CLEOPATRA results and the breast cancer treatment landscape in our post-meeting coverage.

One thing that did capture my attention in the poster area at this year’s ESMO meeting was the bank of digital screens (the size of flat screen TVs) on which attendees could view digital copies of posters. What was even more bizarre was to see people taking pictures of an e-poster.

It will be interesting to see whether paper posters survive, or if they are now one of the last vestiges of the pre-digital era, destined to be phased out like paper cheques. I could see them becoming obsolete at scientific meetings in the not too distant future.

Instead we could have posters published online, with investigators interacting via chat or social media to answer questions from around the world during a dedicated interactive “poster viewing session.” I’ll let the social media gurus ponder that thought, but paperless and digital is the inexorable direction we appear to be going in.

My fervent wish is for conference organizers to ditch Flash-based apps that run on a USB key – these are pretty useless with a tablet – why not have a website with simple digital downloads for the PDFs?  Thankfully, quite a few of the posters achieved this via QR codes on their posters, making them more accessible and easier to read on the go while sparing trees.

ESMO 2014 E Posters

So what’s happening today at ESMO 2014?  Subscribers can login to read which sessions we’ll be at and, wifi permitting, read our thoughts as to what catches our attention during the day. Do follow @MaverickNY on Twitter if you don’t already.

Madrid – it’s Day 2 of the European Society for Medical Oncology (Twitter #ESMO14) annual meeting and the Congress is now in full swing. Today one of the highlights is the Presidential Session that takes place this afternoon. It’s where all attendees have the opportunity to hear what ESMO think is the most noteworthy data at the meeting, irrespective of the type of cancer.

Yesterday, we launched our Live ESMO blog series for Day 1, with commentary and insights posted throughout the day. If you missed the afternoon and evening notes, you can check them out.

Meanwhile, we’re really looking forward to hearing the CLEOPATRA trial overall survival (OS) data in HER2+ metastatic breast cancer at 4pm CET this afternoon.

CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) is an international, Phase III, randomised, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of pertuzumab (Perjeta) combined with trastuzumab (Herceptin) and docetaxel chemotherapy compared to trastuzumab and chemotherapy plus placebo in 808 women with previously untreated HER2-positive metastatic breast cancer (mBC) or with HER2-positive mBC that that had recurred after prior therapy in the adjuvant or neo-adjuvant setting.

Sally wrote on Pharma Strategy Blog about the PFS data for the trial which was first presented at the 2011 San Antonio Breast Cancer Symposium (SABCS).

As Sally noted back in 2011, “the idea behind combining pertuzumab (Perjeta) and trastuzumab upfront is to enable a more comprehensive shut down of the HER2 pathway and delay resistance setting in.”

We’re now looking forward to the final overall survival data that will be presented for the first time at a conference by Dr Sandra Swain (Washington DC) in the Presidential Session at ESMO this afternoon.

There’s a press briefing between 8 and 9 where this data will be featured, so expect news releases to follow soon after this. Out of respect to researchers and those who come to these meetings to hear the data, we typically don’t write about data until after it’s been presented, so expect our initial commentary and analysis to follow later in the day on the blog.

What else are we looking out for at the Congress today and which sessions will the Mav be in? Subscribers can login in to read more or you can sign up below.


Madrid – we’re here in Spain for the 2014 Congress of the European Society for Medical Oncology (ESMO). It’s proven to be a challenging and frustrating meeting on multiple levels so far, but hopefully it will redeem itself over the weekend as new data that changes the standard of care for cancer patients is presented.

At the end of the day it’s all about the data and making a difference to the lives of cancer patients.

The highlight of the meeting so far was yesterday’s Roche media briefing and the presentation by Dan Chen MD PhD on how the company is making advances in immunotherapy. We’ll be writing up the data he mentioned as it’s presented at the Congress. The quote he showed from Ira Mellman, PhD about the promise of Immunotherapy is one that resonates with us:

Roche Promise of Immunotherapy Quote

At prior ECCO/ESMO’s we’ve written about the industry satellite symposia that take place, many of which feature world-class experts talking about new drugs in development or the treatment landscape. It’s a big disappointment to be excluded from these events for the first time at #ESMO14, especially as many are educational in content or even organized by Continuing Medical Education (CME) companies.

That said, by dint of the fact ESMO can accept data several months after the ASCO abstracts have closed there is new data to talk about at this meeting and we have a very full schedule of sessions to attend today at the Congress.

If you would like to read more about which sessions we’ll be in and our initial impressions of data during the day, do sign-in if you’re a subscriber or sign up to keep abreast as the data rolls out.


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!



We continue our “pre-game” coverage of the 2014 ESMO Cancer Congress in Madrid with a look at what’s hot (or not) in prostate cancer at ESMO.

The treatment of advanced prostate cancer has been revolutionized in the recent years with the approval of new treatment options such as abiraterone acetate (Zytiga), enzalutamide (Xtandi) and radium-223 dichloride (Xofigo).  We’ve also seen some expensive flops in late stage development such as: dasatinib (Sprycel), TAK-700 (Orteronel), custirsen (OGX-011), lenalidomide (Revlimid) and cabozantinib (Cometriq) – all failed to show a significant overall survival benefit in large phase III trials.  In addition, sipuleucel-T (Provenge) although an approved new treatment, is considered by many to be a commercial failure, which highlights that it’s not just about obtaining regulatory approval as a key success factor.

The results of the accrued phase III trial with ipilimumab (Yervoy) in the pre-chemotherapy setting (recall that the ipilimumab post-docetaxel phase III trial was a failure) is eagerly awaited.

Next up in the pipeline we have next-generation androgen receptor (AR) inhibitors such as ODM-201 (Bayer/Orion) and ARN-509 (JNJ/Aragon). Phase III trials with these new AR inhibitors are recruiting for the treatment of non-metastatic castration-resistant prostate cancer (CRPC).

Other novel compounds of note earlier in development include galeterone for which a phase III trial is planned, and bromodomain inhibitors.

So what’s hot at ESMO 2014 in prostate cancer?

In the second of our preview series we take a critical look at some of the oral presentations in the preliminary ESMO program: what’s a rehash of ASCO 2014, and what new data are worth looking out for when the abstracts are published?

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ESMO 2014, the Congress of the European Society for Medical Oncology takes place in Madrid next month. Yesterday on Twitter, it was announced that the late breaking abstract titles had been added to the searchable online program.

Late breakers, by definition, provide an opportunity for the most recent data to be presented. Over the next few posts we’ll start to look at the forthcoming program and the late breakers that have been announced.

Obviously until the abstracts are published there’s no data to discuss, but nonetheless the titles give an indication of what may be hot news at the Congress.

For those going to the ESMO 2014 “searchable” online program, be warned it’s not the most user friendly of search engines.

At large scientific and medical meetings, a lot of sessions run in parallel, it’s the only way to get through the volume of data in a few days, and most clinicians tend to be sub-specialists. The plenary, or Presidential session, as its known at ESMO 2014 is the rare opportunity where all congress attendees get together to hear what the organizers think is the most noteworthy, compelling or practice-changing data at the meeting.

Unfortunately, the trend at recent meetings has to been to focus on data from large phase III trials, and indeed at ASCO the plenary featured negative breast cancer data. While we believe that negative data should be presented, since it is particularly informative to those in that specialist area, plenary sessions should ideally have data that make you sit up and think, ‘Wow!’

The American Society of Hematology (ASH) missed the opportunity at their 2013 annual meeting to provide a plenary on chimeric antigen receptor based T cell (CAR-T) therapy, which looks likely to revolutionize hematology. The Novartis/UPenn CTL019 data for the treatment of children with acute lymphocytic leukemia (ALL) was stunning. Readers may recall that Gleevec obtained a plenary at ASH back in 1999 on the basis of dramatic phase I data so a precedent has been set, even if it has not been followed much since then.

At ASCO this year, the compelling data in immuno-oncology, particularly for the treatment of metastatic melanoma by PD-1 inhibitors nivolumab and pembrolizumab and the anti-PD-L1, MPDL3280A, in bladder cancer were particularly noteworthy, and would not have been out of place in a plenary session.

It’s disappointing sometimes to see the committees that vote and decide on which abstracts merit a plenary seem to be traditionalists and not to be on top of immuno-oncology and immunotherapy, where the practice changing data is emerging.  At the current rate, some of these agents are highly likely to be approved by the FDA before they make it to prime time consideration at a cancer conference, which is very strange indeed.

With this in mind, let’s take a look at what ESMO chosen for their two Presidential sessions in Madrid. Subscribers can login to read more, or you can purchase access below.

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