Biotech Strategy Blog

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

Posts tagged ‘CLEOPATRA Pertuzumab Trial’

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.

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The San Antonio Breast Cancer Symposium (#SABCS) starts next week (Dec 4 – 8).

Dr Jose Baselga Interviewed at 2011 San Antonio Breast Cancer Symposium Last year at SABCS, Dr Jose Baselga presented the results of the CLEOPATRA phase III trial in HER2+ metastatic breast cancer.

An impressive 6.1 months increase in progression free survival (PFS) of 18.5 vs. 12.4 months was seen by the addition of pertuzumab (Perjeta) to the combination of trastuzumab (Herceptin) and chemotherapy (docetaxel). You can read more on Pharma Strategy Blog.

Earlier this year, following pertuzumab’s approval by the FDA, Roche/Genentech announced that the CLEOPATRA study results demonstrated that women taking the pertuzumab, trastuzumab and chemotherapy combination lived significantly longer, i.e. an overall survival (OS) benefit. The exact amount of the OS benefit is not yet known, but the data will be presented next week in San Antonio. This is exciting news!

I will not be at SABCS due to the overlap with ASH, but like many will be following via Twitter. Without wishing to offend anyone not included, here’s my starting list of people I will be following for news and commentary:




  • Roche at Congresses @congressconnect (update Dec 6: surprising – tweeted that not covering SABCS this year)
  • Boehringer @Boehringer (added Dec 3)

Patient Advocates/Advocacy & Support Groups


I am sure there will be a lot of people contributing to the conversation from San Antonio so do follow the #SABCS Twitter hashtag for additional people you may wish to follow.

In case you missed it, here is the Pharma Strategy Blog video from SABCS 2011, presented by Sally Church, PhD (@MaverickNY):


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