Biotech Strategy Blog

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

Posts tagged ‘ECCO 2011’

San Antonio – there is a lot of exciting new data at the San Antonio Breast Cancer Symposium (SABCS) this week.

As Sally Church pointed out in her SABCS video on Pharma Strategy Blog, the update to the BOLERO2 data  (previously presented by Jose Baselga at ECCO/ESMO 2011 in September) will be presented later this morning at SABCS.

As a side note it is worth noting that the NEJM paper published yesterday contains the Stockholm data, not the updated data that will be presented later today that will show further improvement in progression free survival (as compared to placebo) in post menopausal ER+ HER2- women who took everolimus combined with exemestane.

Despite the presentation of exciting data at SABCS this week, my opinion is that this is a good meeting, but not a great one (yet). The reason is not the quality of the science being presented this week, but the lack of quality discussants.

The unheralded discussant is the expert that puts the science in context for the audience. Whether it’s a discussion of a simple poster or of a plenary session, the discussants play an important role.

Yesterday at SABCS I sat through two general sessions (the equivalent of plenary sessions at other meetings) in the cavern like auditorium that I estimate sits two thousand attendees.

Of the 15 presentations, only the 3 on bisphosphonates were given a discussant. That is why this meeting to me is good, but not great.  Both ASCO and ESMO/ECCO do a much better job at having a expert put the data in context in an independent and unbiased review.

Why is a discussant important when it’s all about the scientific data?

The challenge with medicine, law and any other professions is that there is so much new data that we can only be experts in a very small area or subset of knowledge.

At SABCS there are basic scientists, medical students, researchers, oncologists, community physicians, patient advocates and survivors. What does the data presented mean to them?

The discussant looks at many aspects of a presentation and can be critical, positive and negative in their observations about:

  • Clinical Trial Design:  what were the limitations?
  • Results:  did it meet the endpoints, was the data significant?
  • Adverse events: is the AE profile a concern?
  • Comparison to literature:  how does this data compare to the literature?
  • Future research:  does this data suggest rational future trials or research?
  • Practice implications:  does the data impact the standard of care?

There are many more questions that come to mind.  Listening to a good discussant brings science to life.

It is, however, challenging being a discussant because like writing a blog, you are generating original content and expressing an opinion.

My view is that if a presentation is good enough to receive an oral presentation at a major meeting, then it’s good enough to be discussed.  I hope that SABCS will offer more discussants in future years and make this a great scientific meeting in return.

The phase 3 ALSYMPCA prostate cancer trial results for radium-223 chloride (Alpharadin) were presented at the recent ECCO ESMO ESTRO 2011 European Multidisciplinary Cancer Congress in Stockholm. This was the highlight of the meeting for me.

There was also exciting data in Breast Cancer (BOLERO-2) that you can read more about on Pharma Strategy Blog.

Alpharadin from Norwegian company, Algeta, is the first new treatment for advanced prostate cancer that not only prolongs overall survival (OS) but delays time to first skeletal related event (SRE) in metastatic castration resistant prostate cancer patients.

Leading physicians at the meeting believe that it will be “practice changing.

The Alpharadin data may also have an impact on other bone targeted agents in development for prostate cancer such as cabozantinib (XL184).

Sally Church, PhD (who writes the Pharma Strategy Blog) is quoted by “The Street” as saying that “Alpharadin raises the bar for Exelixis. They have to produce overall survival data now.” Overall Survival (OS) remains the primary regulatory endpoint in prostate cancer drug development.

Prostate cancer experts Johann de Bono and Cora Sternberg also mentioned, in presentations at the Stockholm meeting, that in the future it will be increasingly difficult to do placebo controlled trials in Prostate Cancer given the new treatment options available.

Alpharadin is not yet approved in Europe or the USA, but is on fast track for approval by the FDA in 2012.

Chris Parker (Royal Marsden Hospital) presented the Alpharadin ALSYMPCA trial data as a late breaking abstract in the presidential session at ECCO ESMO 2011. He also conducted a media briefing that I was fortunate to video.

You can watch this below. In it he explains how radium-223 choloride works and why he (and others) believe this may change the standard of care for prostate cancer patients with bone metastases. It is well worth watching!

 

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Radium-223 (Alpharadin) will be “Practice Changing” is how Michael Baumann, President of the European CanCer Organisation (ECCO) and Jean-Charles Soria, Co-Scientific chair of the 2011 Stockholm Multidisciplinary Cancer Congress described the prostate cancer clinical trial data to be presented in the Presidential (plenary) session on Saturday September 24, 2011.

Alpharadin is the first bone targeted therapy to show an overall survival (OS) advantage in metastatic castration-resistant prostate cancer (mCRPC). To date, none of the other therapies targeting bone in prostate cancer such as zoledronic acid (Zometa), denosumab (Xgeva) or cabozantinib (XL184) have shown any overall survival benefit.

The Alphardin data from the phase 3 ALSYMPCA trial that will be presented in Stockholm shows an increase in overall survival of 2.8 months compared to placebo (median OS of 14 months with Alpharadin versus median OS of 11.2 months with placebo, p=0.00185, HR=0.695).

What is big news is that Alpharadin also significantly prolongs time to first skeletal related event (p=0.00046; HR=0.610). This is tremendous news for prostate cancer patients given the number that experience bone metastases.

It is not, however, good news for Amgen and denosumab (Xgeva). Amgen have tried to associate the improvement in symptoms and decline in skeletal related events with survival, but have failed to obtain any overall survival data (OS). This is something that Alphardin achieves as well as a significant reduction in time to first skeletal related event (SRE).

What Alpharadin has effectively shown is that by nuking bone metastases using a weak alpha emitting radium-223, overall survival (OS) can be prolonged in a way that targeting rank ligand does not. This is ground breaking news and the 2011 Stockholm Multidisciplinary Congress have rightly recognized the importance of this data with a plenary session. For further information on how Alpharadin works – see my previous blog post about the ASCO 2011 phase 2 data.

At the press briefing late friday afternoon in Stockholm, Dr Chris Parker of the Royal Marsden Hospital and PI of the ALSYMPCA study said that “Radium-223, a novel alpha-pharmaceutical, may provide a new standard of care for the treatment of  CRPC patients with bone metastases.”

There is no doubt in my mind that it will lead to a new standard of care. What’s more as Dr Parker speculated in the press briefing, there is no reason why Alphardin could not be combined with androgen receptor antagonists such as the recently approved abiraterone acetate (Zytiga).

Both are well tolerated and operate by different mechanisms of action.  It’s hard not to believe that the overall survival of CRPC patients will be increased by such a combination.

When approved, Alpharadin and any possible combination with Zytiga, may further delay the use of sanofi-aventis’ cabazitaxel (Jevtana) in the post-doctaxel CRPC setting. It may also potentially have an impact on the use of sipuleucel-T (Provenge) in the asymptomatic population.

The Alpharadin phase 3 trial results is exciting news from the 2011 Stockholm Multidisciplinary Cancer Congress. I will be writing more after Dr Parker presents the data in the Presidential session later today.

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