Biotech Strategy Blog

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

Posts tagged ‘ESMO 2014 nivolumab’

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 – 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.


Yesterday’s biotech and pharmaceutical industry news was dominated by the FDA approval of PD-1 inhibitor pembrolizumab (Keytruda) from Merck for the treatment of advanced or unresectable melanoma in patients who no longer respond to other drugs (FDA announcement). Approval was widely expected after the compelling data presented at ASCO 2014 for both pembrolizumab, and another PD-1 checkpoint inhibitor, nivolumab (Opdivo), which was was approved in July in Japan for sale by Ono Pharmaceuticals, a partner of Bristol-Myers Squibb (BMS).

It was amusing to see some of the Academic thought leader reactions to the branding of these drugs:

Not sure if Master Yoda would approve of the names, but no one can doubt that the companies in this space are executing and getting it done expeditiously!   We’ve written extensively about the potential of PD-1/PD-L1 inhibitors from quite a few meeting over the last couple of years so it is good to see them market it market. Melanoma is certainly an area where there is a lot happening in immuno-oncology, and the standard of care will likely be changed by these new agents as they gain approval earlier in the disease and optimal combination strategies are developed that shift the survival curves not only to the right, but also upwards.

BMS recently announced that they had stopped their phase 3 clinical trial of nivolumab first-line clinical trial in untreated BRAF wild type melanoma early in June (press release).  It’s good news for patients with advanced melanoma that there are now new treatment options that will help them live considerably longer.  Skin cancer rates are going up unfortunately, with a third more hospital admissions in the UK over the past five years, which experts believe is down to foreign holidays and the use of sunbeds in tanning salons (BBC Health story).

I expect we’ll hear a lot of excitement at the forthcoming European Society of Medical Oncology (ESMO) meeting in Madrid about what’s happening in immuno-oncology, along with concerns about how countries will afford these new life-saving medicines.

Subscribers can login below to read the next in our ESMO 2014 preview series on what’s hot in melanoma? If you don’t already have access to Premium Content (available only to subscribers) you can purchase access by clicking on the blue button below. Not only does your purchase give you access to future content for the time period selected, but also (at the moment) the back library of all the posts we’ve written to date, so if you missed the data at ASCO 2014, there’s still time to catch up.

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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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