Biotech Strategy Blog

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

Posts tagged ‘cancer vaccines’

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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We have selected five key strategic trends that are emerging that will be critical to follow, understand, and even implement if you are on the coal-face of clinical research and new product development.

ASCO16 Chicago 5We aren’t talking about financial things such as cost toxicity, or even how doctors should be paid, but meaty scientific aspects that we need to watch out for. If we are going to improve on cancer research and R&D in the future, these issues will be important.

For companies and academic researchers alike, there is much to learn from the tsunami of data that hit this week if you have a keen interest in the field and a bent for making sense of patterns out of an amorphous mass of data.

Not paying attention to evolution in clinical development can mean the difference between being in the winners circle, on the outside looking in, or falling way behind your competitors. Playing catch up is never anyone’s idea of fun in this market – oncology moves at a lightning fast pace compared to many other therapy areas.

Intrigued? To find out what these strategic trends are, subscribers can log-in to read the analysis or you can sign-up by clicking on the Blue Box below.

SITC 2015 National Harbor Gaylord MDNational Harbor, MD.  Today was a busy day with the ASH abstracts coming out this morning, and some ground-breaking data that demanded an immediate #ASH15 preview post.

At the same time we’re here at SITC, and keeping an eye on the AACR-NCI-EORTC Molecular Targets meeting – it’s like three buses come at once!

So what happened at SITC today? In this post we’ve put a quick summary of some of the presentations we heard on Day 2 that stood out.  Sometimes what’s most important is what people don’t say.

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The 30th anniversary meeting of the Society for Immunotherapy of Cancer (Twitter #SITC2015) starts today at National Harbor, MD just outside of Washington DC.

Congratulations to SITC on 30 years of Advancing Cancer Immunotherapy Worldwide!

National Harbor MD SITC

It’s an unusually packed conference season this month with the AACR-NCI-EORTC Molecular Targets (#Targets15) meeting in Boston unfortunately clashing with SITC 2015.  In previous years, the Triple meeting has been held in late October, something we hope it will return to in future.

Many of the leading cancer immunologists are at National Harbor…

In our latest conference preview post, we’ve taken a quick look at some of the late breaker and poster abstracts of note and will cover the main oral presentations at the end of each day, so do check back daily for more news and views.

As subscribers already know, we generally provide most of our commentary and analysis after a meeting when we’ve had a chance to hear the data, “kick the tyres” and talk to researchers. However, for those who can’t be at SITC, we will be writing a “top-line”post at the end of each day to give you a flavor of what’s hot at SITC 2015 and our initial impressions of the data we heard.

We typically generate a separate page for each conference we cover, so you can find the SITC 2015 coverage here; it includes some additional posts that make for background reading.

Wednesday’s program at National Harbor starts off with a Global Regulatory Summit (which we’ll miss due to travel) and an International Symposium on Cancer Immunotherapy later in the afternoon.

The weather looks like it’s going to be quite delightful at National Harbor – hopefully the meeting room won’t be as frigid as last year – and in addition to the great science, we’re look forward to meeting up with those of our subs who are here too!

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One of my favourite meetings of the year in our conference calendar is the American Association for Cancer Research (AACR) annual meeting, which is held in the spring. In years past, the agenda at this event has set the scene for the rest of the year in terms of emerging new trends, particularly with regards to targeted therapies. In the last two years though, this hasn’t been the case, as adjusting to the brave new world of immunotherapies has taken some time.

The good news is that AACR has come roaring back in 2015 with a star-studded line-up that includes some of the big hitters and sluggers in the cancer immunology space.

What’s in store for this year, you may well be wondering, and where are we likely to see the new trends evolve?

We took an in-depth look at what’s hot in immunotherapies and where the new directions are going in this latest conference preview, the first one in series relating to the AACR annual meeting being held in Philadelphia from April 18–22nd (Twitter #AACR15).

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Today, I’m going to summarise some of my notes on what we learned about lung cancer and immunotherapy at AACR. The burgeoning immuno-oncology topic is way too big to do justice in one single post, so over the next couple of days, you’ll find a mini series evolving here on BSB to cover many of the points relating to checkpoint inhibitors from AACR. It was the first time in 15 years I’ve seen immunotherapy dominate a basic scientific meeting and it was good to see it happen. It is definitely very much the focus – and excitement – of many major cancer centres in the US.

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