Biotech Strategy Blog

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

Posts tagged ‘ibrutinib’

Are new pillars emerging in DLBCL?

It’s time to take a short break from the immunometabolism mini-series and turn our attention to aggressive lymphomas such as diffuse large B cell lymphomas (DLBCL).

This week heralded the latest AACR virtual meeting on Advances in Lymphoma in conjunction with iCML.  There were plenty of science focused talks to listen to and learn from, including new developments in oncogenic targeting.

What if we can learn from what the patients underlying biology can teach us in terms of more rationally designed clinical trials?

We know these are diverse and heterogeneous tumours, but this doesn’t mean we can’t take a more precision medicine approach to treating patients.  What can we learn from early trial readouts and genetic analyses?

It turns out, the answer is quite a bit and more information might be available at the forthcoming ASH meeting, so let’s look at what we can piece together from the available data now…

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January is inevitably a month where several worlds collide for us.

There might be initial data from SITC and solid data from ASH that bears the advantage of showcasing in the context of corporate presentations at JPM or company announcements of competitor trial progress.

That’s very much the case today.

Earlier this month, Incyte announced the phase 3 trial miss for their JAK1 inhibitor in acute graft versus host disease (GVHD), perhaps coming as a surprise to a few observers familiar with the positive ruxolitinib result, but not so much to clinicians.

In the latter case, one transplanter in the itacitinib study told me at ASCO that he hadn’t noticed any difference between the steroid only and steroid plus itacitinib arms in his SCT patients. Although admittedly that was a small sample of the whole, it did make me wonder if the trend was repeated then it wouldn’t augur well for the overall readout expected year end. Come January, his observation turned out to be rather prescient.

Incyte are presenting on the JPM20 slate in San Francisco today and we’ll be keen to learn if they have anything to add beyond the terse Jan 2nd announcement on the itacitinib miss.

More importantly though, there are still plenty of other agents in development are being investigated for the treatment of acute GVHD, one of which from Alpine Immune Sciences in Seattle we are particularly enthused about following discussions at the recent ASH meeting last month.

In our latest expert interview, we learn more about that development and explore the context for the evolution of a novel molecule likely not on many people’s radar. If the results turn out to be encouraging that situation could well change in the future.

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Gems from the poster halls yielded some fascinating novel approaches and new twists on old targets

In this latest post ASH review, we explore some intriguing early developments from several small and large companies alike, explain why they matter and why we should be interested in them.

Sometimes the wisdom of the crowds isn’t always the best indicator of what’s coming down the pike in terms of oncology pipelines.

Part of our cunning plan this year involved going to ‘off Broadway’ sessions where we thought others would skip in favour of a more obviously popular session (the ones in the big halls) and merrily tweet them so you could easily follow along in parallel while the smaller rooms rapidly filled up and quietly closed to those desperately trying to get in late.

Our selections here include several gems from the poster halls (imagine trying to just pick a few highlights out of 4,000 poster options?!), as well as a couple of oral presentations that were missed by many – not surprising given how jam-packed the schedule was with double and even triple choices of selections in parallel to choose from!

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ASH19 Targeted Therapies Preview: This year’s ASH in Orlando is very much dominated by new developments on the immunotherapy front in terms of both T and NK cell therapies, with some passing interest in BTK inhibitors as well.

It’s not always sunny in Florida…

What about targeted therapies and the science behind those developments?

It was not that long ago that these were the main lifeblood of the meeting across many, if not most, hematologic malignancies. How times have changed!

That said, outside of the CARs (T and NK cells), as well as bispecific immunotherapies, and BTK inhibitors there are still some gems to be found amongst the rest of the ASH19 abstracts.

Here we highlight an additional 10 abstracts involving early pipeline areas that encompass some novel targets, new combination approaches, or emerging science.

Please note that the novel targets can take the form of classic targets or IO ones since they didn’t fit in the prior ASH Preview topics already reviewed under separate cover

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Orlando bound for ASH!

What is old is new again…

I have that distinct feeling of deja vu with the ASH asbtract drop yesterday on several fronts. It’s quite a few years now since we wrote about the runners and riders in the BTK/PI3K race to market in CLL and by weird coincidence a topic I was covering by interview yesterday on the RAS pathway came up in one of the first ASH asbtracts I was reading, which was rather spooky. Clearly Halloween came slightly late to Florida this year!

So how do all these disparate topics hang together and why are we excited about a small cap biotech company that is largely under many people’s radar?

They have some unexpected unifying threads…

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Standing from the crowd in refractory CLL?

Last year the two FDA approvals of tisagenlecleucel (Novartis) and axicabtagene ciloleucel (Kite/Gilead) CAR T cell therapy for hematologic malignancies such as pediatric acute lymphoblastic leukemia (pALL) and non-Hodgkins lymphoma (NHL) have captured a lot of attention.

It’s worth remembering, however, that back in 2010 the first patient who had a dramatic response to CD19 targeted CAR T cell therapy was actually a gentleman with advanced chronic lymphocytic leukemia (CLL), the case study of which was subsequently published by Porter et al., (2011) in the New England Journal of Medicine.

We’ve been following CAR T cell therapy and its potential in CLL for some time now, with all the successes, trials and tribulations along the way.

Dr David Porter (Penn) told BSB earlier this month:

“The very first patients we treated are now eight years out from their infusion, a little over eight years, and still in remission, still doing extremely well with no evidence of disease or progression, never had any other therapy. So, I think it’s become very clear that for some patients this is effective in the far advanced setting.”

It’s now two years since we last spoke and it was a great pleasure to reconnect with Dr Porter. As he told BSB at ASH in San Diego:

“One way you make it better is to understand why it’s working and why it’s not.”

What have we since learnt about the potential for adoptive cellular therapy in CLL and what new insights did we gain from new data presented at ASH18? The answers may well surprise you.

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What latest ASH18 data jumps to our attention?

San Diego – It’s time to put another dozen studies in the spotlight and review what we can learn from the existing data with a view on where we’re headed in the future.

Today’s list covers a whole gamut of targeted therapies, bispecific antibodies, CAR-T cell therapies and other immunotherapies, what’s more we have a range of targets in the list too, and not the obvious ones either.

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What a wet wet wet start to the annual meeting of the American Society of Hematology (ASH) meeting being held in San Diego – quite a change from the snow in Atlanta at last year’s event!

Either way, does it precipitate a windfall of excellent data?

A lull between the rain – a soggy day in San Diego

Here are some of our early highlights, which include updates on neoantigen vaccines, novel approaches with CAR T cell therapies, NK cell therapies, targeted therapies and more…

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Buried amongst the intense hurly burly of a major medical meeting such as the American Society of Hematology (ASH) are the unsung preclinical researchers whose work largely makes clinical development possible. After all, few sensible companies would bet on an expensive clinical trial program, especially in combination, without first knowing whether such an approach is rational or not and has a decent shot of working efficaciously.

At stake here is the potential for building a blockbuster cancer drug niche by niche.

Venetoclax (BCL-2 inhibitor) got off to a somewhat slow start compared to say, ibrutinib (BTK inhibitor), which had a much broader initial indication and a lower risk of tumour lysis syndrome (TLS), yet it may actually have a wider application across multiple hematologic malignancies. This could well end up as one of those classic tortoise versus hare stories in the long run.

Back in 2013, we posted five interviews conducted with a range of experts including:

  • Dr Oliver Sartor (prostate cancer)
  • Dr Susan O’Brien (CLL)
  • Dr Deepak Sampath (BCL-2 and ABT-199)
  • Dr John Jenkins (then deputy director at the FDA)
  • Dr Renier Brentjens (CAR-T cell therapy)

To put this in context, consider that we just recorded 15 interviews at ASH this year alone!

As regular readers know, we like to follow people and R&D stories over time, so while in Atlanta at ASH17 we took the opportunity to move a particular story forward – we wanted to learn where Dr Sampath and his colleagues are now and also where they are headed next. This gives readers a head start on anticipating what future clinical developments might be mentioned at JPM18 by either Genentech/Roche or AbbVie.

In our latest expert interview, we pick up and continue the discussion with Deepak Sampath to find out what’s happening with venetoclax four years on… it turns out quite a lot and makes for very interesting reading indeed.

Dr Deepak Sampath (Genentech)

Curious to now more about what this scientist and his work in BCL-2 targeting is all about?  Check out this short excerpt:

 

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In our latest thought leader interview from the annual meeting of the American Society of Hematology (ASH) Dr John Leonard (Weill Cornell) provides a lesson on how to interpret key lymphoma data such as ECHELON–1, CAR T cells, and other topics at ASH, as well as what he’d like to see more of in lymphoma clinical trials.

In this hard-hitting interview, Dr Leonard reminds us that the media should not be a mere extension of the PR of companies. Instead he offers his real world insights into what may or may not be practice changing, and how we should interpret CAR T cell therapy data.

Dr John Leonard (Weill Cornell)

It’s a must read for anyone with an interest in lymphoma… here’s an excerpt to give you a flavour of the wide ranging discussion:

 

 

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