Biotech Strategy Blog

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

Posts tagged ‘T cell trafficking’

We’ve come a long way over the last two years in the oncology market, with several novel approaches approved, numerous major phase 3 trials evolving and a huge turnaround for many companies in terms of early pipeline activity.

ASCO 2016 Posters 3

The melée at the ASCO 2016 Poster Hall

Unfortunately, this also means that the tendency of lemming activity also increases in the rush to copy everyone else and not be left behind.  Just a couple of years ago, some industry friends grumbled that there were over 20 checkpoint inhibitors chasing them in development; they may be surprised to know that now there are nearly 70!  This is both unprecedented and unsustainable, and yet it’s also a function of the perceived success these agents have had on the cancer R&D landscape to date.  Everyone wants one for fear of being left behind… except that many are indeed way behind already.

You can imagine the tall guy on the left of the picture looking at his watch and wondering, “Ah so many new posters, so little time!”

Meanwhile, as the rate of approved cancer therapies increases, so does the inexorable march in terms of hyper-aggressive basket pricing.  I would argue that at some point, it no longer acceptable or even conscionable to change a premium or even market rate for drugs that give an incremental improvement of a mere 2 months of extra life.

Equally, one thing that many industry observers and the media love to do, and wrongly in my view, is to compare the individual drug prices on an annualized basis.  This is silly for several reasons:

  1. So far, not all patients are treated for a full year
  2. If patients are treated until progression and that happens early, then therapy is stopped
  3. What people should be looking at is the average treatment cost based on the length of therapy – some people will receive a few months and some much more than that
  4. What’s the true cost of a cure or remission to a patient and their family?
  5. How do we quantify the impact of the long lasting durable remissions?

These questions will become increasingly important as we see a more aggregated therapy approach emerge over the next few years.

By this, I mean that we are now going beyond monotherapy and even combinations; those trials have already long started and are the low hanging fruit that has been rapidly snapped up by the early players, as we eagerly wait for their data readouts.

If you have new agents coming-out of preclinical and into phase 1 development over the next year, there are a number of important questions to consider:

  • What are you going to do and where do you start?
  • How do you gain an edge when coming from (way) behind?
  • How do you develop unique positioning that could sustain your molecule in a sea of similar competitors?
  • Is it realistic to expect the 17th and 50th checkpoint to have equivalent efficacy as what went on before and will all of these seriously make it to market?

You can see now why even the FDA’s Dr Richard Pazdur was moved to grumble about the surfeit of me-toos here and company expectations that the FDA should consider them – it’s on a massive scale that we haven’t seen before.  For once I agree and empathize with him over that dilemma, it’s madness to think they will all be as good as pembrolizumab or nivolumab.

What we are starting to see emerge now is a surprising synthesis of ideas and a merging of disparate approaches. How will this affect oncology R&D over the next 1–5 years?

A couple of smart readers wrote in asking about these emerging trends, what have we identified so far, and where do we see the oncology space going in the near to medium term future. Now that AACR and ASCO are behind us, what can we learn about the new developments and where they all fit in the oncology landscape strategically?

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One of the (many) highlights for me at the recent annual meeting of the American Association for Cancer Research (AACR) was a “Meet the Expert” session presented by Professor George Coukos.

Prof George Coukos AACR 2016

Prof George Coukos AACR 2016

Professor Coukos is Director of Oncology at the University Hospital of Lausanne and Director of the Ludwig Institute for Cancer Research in Switzerland.

Ovarian cancer is becoming a fascinating battleground for cancer immunotherapy, with multiple challenges that must be overcome before we see improvements in outcomes, especially for women advanced disease.

The interview with Prof Coukos is a follow-on to the one we did on advanced ovarian cancer and checkpoint blockade at ECCO 2015 in Vienna with Dr Nora Disis (Link).

If you missed it, you can still listen to highlights in Episode 7 of the Novel Targets Podcast (Link).

After his AACR presentation, Prof Coukos kindly spoke with BSB and in a wide ranging discussion, highlighted some of the innovative clinical trial strategies he is working on to move the cancer immunotherapy field forward in ovarian cancer.

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One of the unintended consequences of the rise of cancer immunotherapy has been the fall in interest from patients who might be candidates for entry into clinical trials for other therapies, such as chemotherapy and targeted agents, for example.

St Charles Streetcar New OrleansA number of industry friends have uniformally expressed concern over how difficult it has been enroll such trials and bemoaned the broader – and often not anticipated – effect to the extent that some trials have even been terminated.

This situation often occurs, not because of lack of efficacy or severe side effects, but simply a lack of enthusiasm and low accrual rates. Quite a few patients consider chemo to be nothing short of ‘poison’ and don’t want anything to do with it as a result, unless it can be avoided.

Here’s my advice to those in this situation – stop moaning, start re-thinking, and re-positioning your agent in a different light to the investigators who enroll these studies. If they lack heart, in a highly competitive world, you have to stand out and thus, everything flows from the basic rationale of what you’re trying to accomplish.

What exactly do we mean by that?

Yesterday, we discussed one of the rate limiting steps in the cancer immunity cycle – getting more T cells into the tumours so that that subsequent immunotherapy can be even more effective.

One way to do that?

Chemotherapy!

At AACR recently, we came across some intriguing ideas and approaches that are being discussed and explored, which may open many people’s eyes and minds. It rapidly became clear during discussions with several experts that all is not what it seems, and smart companies are already taking advantage of the new science that is emerging as well as a deeper understanding of the underlying biology of how the immune system behaves in cancer patients.

Here, we offer insights from our latest interview with a thought leader in the field for his perspective on how we can improve response rates and outcomes with cancer immunotherapy.

Fair warning: I must confess that it opened my own mind to fresh ideas and different approaches in an unexpected way – you may experience the same sentiments.

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UNO SignIn our post AACR analysis, I noticed some consistent observations across multiple talks and informal discussions with thought leaders.

Some of these ideas are pretty important and help us see the big picture for the near and medium term future in the cancer immunotherapy space.

The “Claws” sign we saw at the University of New Orleans sums things up!

Without much ado, it seems a good point to capture and summarise these ideas so that readers can compare notes and debate their thoughts too.

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It’s the end of April and just in time for two important things here on BSB…

Dan Chen and Ira Mellman on Novel Targets PodcastA) Season 2 of our Novel Targets podcast has now kicked off!

The first show (sponsored by Genentech) explores the cancer immunity cycle (CIC), how it can help see the bigger picture and how this framework can be used to help figure out what areas are missing when patients don’t respond to immunotherapy.

There are also predictions about what we will see coming up in the next year – will the crystal ball be accurate – or not?

Crank up the Sonos, grab a coffee, pen and paper – you’ll find the latest podcast show here (Link), which is open access for anyone who wants to listen.

B) Reader Q&A Mailbag: we tackle your latest tough questions that are top of mind and offer insights on the hot topics people want to know about.

We have a broad range of topics to cover today including:

  • The battle for PD-1 sales
  • What are the IO bottlenecks where we can expect to see new research focus
  • Sanofi-Medivation bid
  • AbbVie snapping up StemcentRx

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