Biotech Strategy Blog

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

After yesterday’s notes on the exciting lung cancer clinical trials plenary, I received a bunch of questions from readers following yesterday’s analysis of the 1L NSCLC market.

This is a good opportunity to take some time out to answer some of them, as they highlight some important points worth discussing, clarifying and reviewing.

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Chicago: It’s been a crazy busy day here at BSB, with embargoes, key data, thought leader interviews around town, the poster hall and plenty other things to think about.

What I wanted to do here was take a step back after the dramatic 1L NSCLC session and pull together some pros and cons that oncologists will be thinking about going forward.

There’s a lot going on in this market that is worthy of further discussion and debate…

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The lull before the Monday storm hits…

One of the highlights every year at the annual meeting of the American Association for Cancer Research (AACR) for me is catching up on new product development and finding out which molecules are moving along and which have encountered unexpected issues and most importantly, why. Drug development is an inexact science, after all, and sometimes it is more akin to art.

Sometimes you hear of a promising new or very early molecule in these sessions and follow them all the way to the market, while other times they get touted as such and then flame and burn out later.  Some years are also better than others, for obvious reasons.

How did 2018 turn out?  What’s to watch out for this time around?  A couple of years ago we had a dismal session here with the majority of agents clearly destined to the scrapheap and the poor researcher was dutifully performing the office of last rites. This year I’m pleased to say was quite different and there was much to be encouraged by…

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We often talk about ‘on-target off-target’ side effects, but what about the equivalent on-site off-the-reservation meetings?  I’m a big fan of these, it has to be said.

Spring time in Chicago feels more like… October – brrrr!

My first day at AACR18 in Chicago this year was sandwiched by two such events, one of those welcome to AACR moments – never mind the frigid weather – to be sure.

First off, you have to be on the relevant distribution lists to get invited, then hope the organisers accept your registration, such is the life of scientists on the dark side (journalism/media).

In the past, these off-reservation scientific events around AACR have been well run and very useful for picking up new companies or targets ahead of the mainstream news and this year I wasn’t disappointed.

One of the Previews that I didn’t get time to write up was on CAR T cell therapies because there was a huge surfeit of new companies, new targets and lots of unproven mouse data, which is a recipe for speculation without representation (of clinical data).  So on the basis that the good stuff will rise to the top, I figured that it might be more efficient to summarise an event instead, as past events have proven very useful in this somewhat singular approach.

We all know that we need to go beyond CD19 as a target in hematology malignancies, and that the promise in solid tumours is high, but data scant, so where are the gems to watch out for?

Here. we take a look at some up-and-coming approaches and companies to watch out for to cut to the chase for BSB readers interested in this space…

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The convergence between targeted therapies and immunotherapies with genomics has already started in many areas of cancer research – we can imagine the intersections more as a Venn diagram than as separate entities these days.

Lobster pots on the shore

While former graveyards of R&D such as metastatic melanoma and lung cancer have seen a dramatic revival in positive trials over the last five years, things have languished somewhat in other areas.

Womens cancers such as high grade serous ovarian cancer (HGSOC) and triple negative breast cancer (TNBC) have seen some new developments with the advent of PARP inhibitors as monotherapy or maintenance, but there is still a ways to go in terms of overcoming resistance and improving outcomes further.

You might be puzzled what on earth lobster pots have to do with cancer research? In short it’s an apt analogy from life because while there is much promise in the right situation (under the sea in a good situation), they can also look like a helpless mess (abandoned on the shore).  Oncology R&D is a bit like that too and finding the right situation viz molecule development and clinical trial design, not to mention discontinuation is very similar in that respect too.

In our latest AACR18 Preview, we take a look at an underappreciated oncology drug class and look at the opportunities for future combinations that may take a few readers by surprise…

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Things are heating up rapidly in the 1L non-small cell lung cancer (NSCLC) space with the latest news that Merck’s pembrolizumab beat out chemotherapy as monotherapy in previously untreated stage 4 patients in KEYNOTE-042.

Is the path to success is a rocky road for some companies in 1L NSCLC?

BMS’s trial in this setting, CheckMate-026, previously failed to show any benefit for nivolumab over chemotherapy, so what gives?

There is no doubt that Merck have been on a roll in lung cancer of late with nary a false step with pembrolizumab thus far.  Is that down to luck or careful preparation?  Are there differences in the molecules or trial designs?

Here, we take a look at the two situations and continue our ongoing analysis as these results certainly offer a ‘tale of two cities’ perspective in the same indication.

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With the sad and very gloomy news that Incyte’s IDO inhibitor, epacadostat, has missed in the phase 3 ECHO–301 study in metastatic melanoma, is there still hope for IO-IO combinations in the pipeline?

Here, we take a quick look at the Incyte announcement briefly, but more importantly, we also look forward to other combinations that might be of interest to those following the cancer immunotherapy space.

Not surprisingly, there is a lot to look out for as our sixth post in the AACR18 Preview series highlights as we look through the IO window to potential future developments of interest.

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Finding patterns in the mosaic of cancer biology

In our fifth AACR preview of the annual meeting of 2018, we switch directions from a tumour type to explore a novel and emerging pathway of interest.

Each year we pick a different target to explore; this year it’s the turn of TGFβ.

There’s a lot going on here, both preclinically and clinically that should interest BSB readers who are keen to see new developments in the IO landscape.

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As part of our annual AACR Preview series, we usually explore new developments in at least one tumour type and one new target of interest.

Bladder cancer cells infected with BCG Source: Dr M Glickman, MSK

This year is no different and there were plenty of opportunities to discuss.

We have already covered lung cancer given the intensive interest in the phase 3 trials being presented in the 1L setting, but I also wanted to cover another key tumour type that is generating a lot of keen interest in clinical development for numerous reasons.

Tomorrow we will be exploring a cancer target in detail, but there is much to cover in terms of new preclinical and clinical developments in certain carcinomas.

Without much ado about nothing since there is plenty of important things to discuss, so here’s a look at our second tumour type to watch out for given the sheer numbers of trials, including a variety of different targets to think about.

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One of the many challenges we have seen with cancer immunotherapy and immune checkpoint blockade in particular is the thorny issue of how long should patients be treated for?

To be fair there are some studies testing a limited time period, but most are open ended in that patients are treated until progression or severe toxicities prevent continuation, whichever comes first.

Ovarian cancer TME Source: NCI

Is this the optimal approach though, especially if people receive the benefit and any more is superfluous, thereby increasing the twin burdens of clinical and financial toxicity.

Are there indicators that predict early discontinuation?

After all, if oncologists were aware of those factors then careful monitoring will be helpful in looking out for the warning signs.

Without a doubt, this is going to be a long road ahead and the path may be paved with different indicators depending on the tumour type involved. It could also become more complex as we move from monotherapy to doublets to regimens, which also increases the risk of clinical and financial toxicities.

We have to start somewhere and I’m delighted to say that I came across some elegant research that explored this issue and came up with some prediction factors of relevance. As a bonus, they actually make sound and intuitive sense too.

Here we describe the important study and look at the prediction factors that emerge…

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