Biotech Strategy Blog

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

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Non-small cell lung cancer (NSCLC) is big news this morning with the announcement from Genentech/Roche that the IMpower150 trial exploring whether adding atezolizumab to the standard of care Avastin plus chemotherapy hit it’s first co-primary endpoint of PFS. The data will be presented at European Society for Medical Oncology (ESMO) Immuno Oncology Congress in Geneva, Switzerland next month. The other co-primary endpoint, overall survival, is expected in a couple of months.

I’m delighted that this trial hit a positive note, especially after a few folks were surprised at our emphatic positive prediction for both the PFS and OS outcomes in reviews this year when we looked at it in the summer and again in the fall – see: predictions in 1L NSCLC trials followed by red and green flags.

In the meantime, recently there was some very important news in the lung cancer niche relating to the field of genomics and our understanding of how tumours develop and evolve.

It’s easy for many folks to forget that even in a tumour type that is considered to be a hot/inflamed one due to the high tumour mutation burden (TMB), not all patients respond to checkpoint therapy upfront and not all will achieve lasting durable responses that go out five years. Resistance (primary and acquired), as well as immune escape, will inevitably have a large impact on many patients.

Understanding the underlying biology of the disease will not only help us figure out the causes of non-response and relapse, but also explore rational combination approaches that might improve outcomes.

Just as the triplet of atezo/bevacizumab/chemo has now been show to be superior to the control doublet, we may well see other approaches evolve in the near to medium term future.

The Dynamic Duo at #TARGETS17

Up on deck today is a timely yet rare joint interview that explores the science behind how cancers (including lung cancers) evolve and adapt to try and evade not only detection, but also being destroyed, by anti-cancer therapeutics.

Professor Charles Swanton (Crick and UCL) and Dr James Gulley (NCI) make for a thoughtful and compelling double act.

It was an absolute delight and a privilege to conduct our latest BSB fireside chat with them together. What they had to say was fascinating.

Often we have jested about putting researchers in the BSB hotseat, but frankly when it comes to people of this calibre, the tables are usually turned and the interviewer is the one in the hotseat with some selective pressure to keep up and maintain a flow of intelligent questions!

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SITC2017 Poster Halls

National Harbor, MD: It’s time for the first of our Gems from the Poster Halls following the Society for Immunotherapy of Cancer (SITC) annual meeting over the weekend.

It’s time for a look at biomarkers of response and some novel approaches in development. In the past we have covered circulating tumour cells (CTCs), cell free DNA (cfDNA), circulating tumour DNA (ctDNA) and even exosomes.

As Monthy Python would say — now for something really different…

What about a more integrated approach?

Yes, it’s possible and no, I’m not talking about the classical nonogram either.

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Sometimes initial phase 1/1b readouts at cancer conferences produce quite different reactions from a live and remote audience while at other meetings, the Developmental Therapeutics talks produce little or no interest at all. It’s often hard to guage which way they will go.

At SITC this weekend, several talks generated some contentious, and at times quite heated, debate and intense interest.

One of these was an oral presentation by Dr Zev Wainberg on the first-in-man data with the anti-CSF1R and anti-PD1 inhibitors, cabiralizumab and nivolumab, from Five Prime and BMS respectively, in an advanced pancreatic cohort.

Dr Zev Wainberg at SITC 2017

There was a surprising amount of confusion surrounding the initial results and other issues last week, with Five Prime’s stock dropping before we’d even got to Dr Wainberg’s talk.

What became increasingly obvious over the weekend was a clear difference in investors perceptions versus what the scientific community actually thought.

Here we take a look at the data and explain what to watch out for and why…

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SITC 2017

Treatment with checkpoint blockade has undoubtedly improved the lives of some people with advanced cancers such as melanoma and lung cancer, however the number who do achieve complete remission with single agent therapy is low (typically <20%).

In addition, not all people will respond up front while others achieve an objective response then relapse as acquired resistance or immune escape hits.

One challenge facing the field is identifying these mechanisms of resistance and finding the optimal combination approaches that lead to improved outcomes.

This weekend at the Society for Immunotherapy of Cancer (SITC) annual meeting, there were quite a few interesting new combination developments with early data.

Here, we take a look at one such combination to explore the data, the biomarker research that is ongoing and also some of the challenges associated with finding needles in the proverbial haystack…

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We’re at a crossroads in the IO space, where much of the low hanging fruit has been already plucked and now we could be in limbo for the next 2–5 years while we wait to see which of the IO-IO or IO-other combos pan out as winners.

Part of the problem is that we don’t yet know all the potential mechanisms of resistance or immune escape involved, so imagine figuring out how best to optimally modulate the tumour microenvironment on top is going to be challenging – each tumour type is heterogeneous and highly complex.

In addition, the field has heavily skewed towards obsessing almost exclusively over T cells, which may or may not be a good thing.  There are alternative approaches that are starting to generate interest and results.

As Andrew Shepherd, the fictitious leader of the free world in the American President famously said:

“We have serious problems to solve, and we need serious people to solve them.”

One promising company in this space is Nektar Therapeutics.  At SITC this week they had some elegant and intriguing early data that combined an innate immunotherapy approach with checkpoint blockade.  We have been following their progress for a while now and it’s a great time for an update!

Dr Adi Diab NKTR-214 #SITC2017

Here we explore the data and have our latest expert interview that is not merely a couple of paragraphs long with a few platitudes or topline quotes… this is, quite frankly, a comprehensive review and strategic roadmap of what Nektar Therapeutics are doing in the IO space, why they are doing things a certain way, and where they are headed – in their own words…

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National Harbor, MD – Day 2 of #SITC17 brought some interesting highlights on a number of fronts, not all of which may be apparent at present, but there are a few readouts that will have a broader impact going forward.

SITC 2017 Stars?

As we move into an era where we see more combinations evolve in immuno-onology, things are likely to get more confusing rather than less so and it could well be another 3-5 years before things truly settle down and more concrete trends emerge.

Here, we reviewed 10 different areas of interest with a strong clinical relevance and explored the topics further.

Please note that some of these will also have follow-on posts with thought leader interviews and related poster reviews.

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Dr Stephan Grupp at SITC17

National Harbor, MD – SITC 2017 wouldn’t be the same without an in-interview with Dr Stephan Grupp (CHOP) on the issues surrounding the Juno ROCKET trial and CAR T cell therapy safety.

This data has been eagerly awaited and anticipated by the field since the news of a cluster of lethal cerebral oedemas hit Juno in the summer 2016, seemingly out of the blue.

Yesterday, we reviewed the salient points from Dr Mark Gilbert (CMO) presentation highlighting their findings from the in-depth analyses performed to date.

In the second part we turn to a CAR T cell therapist with experience in treating children and young adults for his perspectives and candid reactions to the information presented.

We also talk about where the field is headed and some of the new developments we can look forward to hearing more about in the near to medium term future.

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SITC 2017 at the Gaylord Hotel, MD

It’s that time of year already and it has come around so fast in 2017… yes it’s the annual meeting for the Society for Immunotherapy of Cancer (aka SITC).

This year there are several eagerly anticipated presentations, one of which is Juno’s ill-fated ROCKET trial in adult ALL using their JCAR015 CAR T cell therapy.

While Novartis and Kite both successfully made it to market recently in pediatric ALL and aggressive lumphomas, respectively, Juno were left languishing in a poor third place after a series of lethal cerebral oedemas scuppered the program.  In the meantime, Novartis are relentless chasing Kite with their JULIET trial in DLBCL and could well have the third CAR T cell therapy indication.

Finally, we heard for the first time today what the company learned from the recent analysis of the deaths, which they shared with the field this morning.  BSB was on the spot to hear more about what the CMO, Dr Mark Gilbert had to say and we also have some thought leader sentiments on their perspective of the findings.

That’s not all though, as there was also new data on checkpoint blockade and other immunotherapies that are in early development as well as developments on the biomarker front.

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With the annual meeting of Society for Immunotherapy of Cancer (SITC) fast approaching this week, it’s time for a look at some of the final highlights to watch out for.

National Harbor from Gaylord HotelIn this latest conference preview, we have chosen a dozen key topics of interest that readers may find worth checking out plus an honourable mention for early compounds in development that we may well hear more about going forward.

Some of the early warning signs were offered up in the earlier Previews and with the abstracts now available, things are getting very interesting indeed…

How are things panning out so far with the abstract drop and are the new products in development living up to the hype and expectations?

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Before we move on to the Society for Immunotherapy of Cancer (SITC) meeting later this week, it’s time to wrap up the exciting AACR-NCI-EORTC molecular targets conference, which along with the CRI-CIMT-EATI-AACR international cancer immunotherapy conference in Mainz, have been my two favourite oncology meetings of the year so far.

Who would have predicted that back in January?

A scoot around the narrow #Targets17 poster hall…

It would be hard not to close out coverage without a popular Gems from the Poster Halls post.

Typically, we have focused this theme from cancer conferences around the following:

  • A new target
  • An interesting molecule
  • Intriguing basic or translational science of note
  • A particular tumour type
  • Insightful sentiments from thought leaders

In this latest version, we have examples of each.  We also have my favourite quote and discussion from the meeting, which perhaps not surprisingly, comes from a CAR T cell therapy discussion.

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