Biotech Strategy Blog

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

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Whenever one attempts to do a top 10 list of almost anything, there will inevitably be fans and detractors in equal measure and this BSB list is likely to be no different in that respect!

This week’s Fun Friday post highlights some important abstracts to watch out for in advance of ASCO 2017, so without much ado about nothing, you can check out our selections, some of which are likely to be controversial.

As usual, we also explain why they are important and what lessons can be learned.

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Chicago RiverAlthough ASH and ASGCT are important meetings for CAR T cell therapies, there are still some intriguing data to be had at ASCO next month, including both oral and poster abstracts.

In our latest ASCO 2017 Preview, we take a look at what to expect from in the CAR T cell space.

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If there’s one topic that has generated a LOT of questions from BSB readers this month it is Puma Biotech’s neratinib in adjuvant breast cancer.

The FDA briefing documents came out yesterday and that started another flurry of ‘what do you think of them?’ style questions so here goes.  I will say that while many are eulogizing ‘benign’ or ‘friendly’ on close reading and studying them, I’d say caveat emptor.

Things are not always what they seem.

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ASCO 2014 Chicago Contemplation

Contemplation in Chicago ahead of #ASCO17

As part of our ongoing American Society of Clinical Research (#ASCO17) Preview series (we’re on number 5 already), we turn our attention to an upcoming area of cancer research that is expected to play an important role in future clinical trials and combination regimens because of the mechanism of action involved.

It may also turn out to be a very handy and important approach for turning cold into hot tumours.

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As we all wearily trawl through the huge mountain of data for ASCO 2017, what stands out – and more importantly – what matters and why?

Before we get into our in-depth coverage based on the tumour type, target and modality landscapes, I wanted to take a moment to highlight five key abstracts that stood out for me as worthy of checking out in more detail once we get to Chicago.

Interestingly, only one of them is from big Pharma!

At least one had some negatives associated with it as we’re not all happy clappy everything is great enthusiasts here at BSB.  We do try to be fair minded and objective as possible about data.

So what’s in store and why do these five matter?

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IDO/TDO inhibition is a topic we’ve been following the progress on for several years now with various updates along the way. It’s also one of our most requested Previews for this year’s ASCO meeting taking place next month.

The Bean, Chicago

In Chicago next month, initial data from several trials is due to be presented.

  • What can we expect?
  • How are the main players in this landscape doing?
  • Will this combination be the next big thing in the oncology IO space?

In our latest #ASCO17 Preview, we take a hard look at IDO/TDO inhibitors.

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We are finally at the end of our AACR 2017 post meeting analysis and coverage with the final interview from Washington DC on deck. Timely wise, it’s actually quite a relevant one given the news last week on mixed results with clinical trials involving checkpoint blockade.

Just as we learned that immunotherapy agents can stop working over time, as well as the majority of patients don’t respond at all to begin with, there are concerted research efforts ongoing by both academia and industry to explore mechanisms of immune escape, resistance and modulating the tumour microenvironment.

Here we explore the intersection of targeted therapy-IO combinations, resistance and immune escape, transcription factors and other interesting new areas of development.

Also included is commentary from a leading KOL, which is NOT available on the recent Novel Targets podcast episode on overcoming immunotherapy resistance – readers should check that out first before reading this article, as this is more advanced.

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Until recently, we followed the race to market in EGFR T790M lung cancer with Clovis’s rociletinib and AstraZeneca’s osimertinib (Tagrisso).  In phase 2, AstraZeneca caused quite a stir when they came from behind and leapfrogged their biotech rival with a large global randomized controlled trial seemingly out of nowhere.  They never looked back.

Can they do the same thing with durvalumab (Imfinzi), one of their IO therapies that targets PD-L1?

If there’s one thing that many astute observers of the IO space have learned this week it’s that irrational exuberance and the hopeful sentiment that ‘everything’ will just tweak the immune system and work positively no matter what has thankfully come to an end.

We’ve seen several highs and lows already with Merck’s pembrolizumab gaining accelerated approval in 1L NSCLC in allcomers when combined with chemotherapy and AstraZeneca reporting positive phase 3 data for durvalumab in unresectable (stage 3) NSCLC based on meeting the study endpoint (PFS).

There is much to be learned because the nivolumab disaster in 1L NSCLC last year was not a singular aberration given that durvalumab has seen some missteps in the past and even atezolizumab had some unexpected news with urothelial cancer this week (Check out our insights), as compared to chemo in the second line setting. Just like mutations, there will be many more to come, perhaps even some additional ones before the year is out.

What about today’s news from AstraZeneca in unresectable NSCLC?

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We’re overdue a roundup and discussion on various key topics of interest to BSB readers, so here goes…

Today’s topics include an in-depth look at the impact of some negative events:

  • Kite and the cerebral oedema death with axi-cel
  • Genentech’s atezolizumab OS miss in urothelial cancer

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We now turn our sights to targeted therapies and DNA Damage Repair (DDR). This is an important topic that has seen much focus in ovarian cancer of late and will likely see renewed interest in breast cancer at the forthcoming ASCO meeting next month. As we segue from one set of conference coverage to the next, there is inevitably going to be overlap, which is a good thing here as it helps with background and preparation in getting up to speed.

There is no doubt that DDR has had a bit of chequered history over the last decade, whether it be the spectacular (and sadly predictable) flop of Sanofi’s iniparib in triple negative breast cancer (TNBC), the negative ODAC incurred by AstraZeneca’s olaparib in ovarian cancer, or AbbVie’s more recent veliparib failures, to the much more positive events such as three PARP drugs now approved in different lines of therapy in ovarian cancer (olaparib, rucaparib and niraparib).

If ever there was a niche for the roller coaster ride that is oncology R&D, it has to be PARP inhibitors.  There’s much more to DDR than just PARP though.

Indeed, there are multiple intriguing targets to explore and also the potential for combinations with cancer immunotherapy approaches that may yield encouraging results in the future.

Can we go beyond ovarian cancer into other tumour types and if so, which ones look encouraging and how woluld we go about exploring those idesa? What makes one approach more successful than another?

Here we explore the world of DDR through the lens one company’s approach and look at what they’ve done, where are they now and where they hope to be. It certainly makes for an intriguing and candid fireside chat.

Want to learn more and peak ‘Through the Keyhole’?

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