Biotech Strategy Blog

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

Posts tagged ‘venetoclax’

Over the last five years the face of the chronic lymphocytic leukemia (CLL) landscape has changed quite dramatically with the advent of new approvals in several categories. These include anti-CD20 antibodies, BTK inhibitors, PI3K inhibitors and apoptotic Bcl–2 inhibitors.

In yesterday’s wide ranging interview we explored in-depth how these therapies are impacting the broader landscape, as well as emerging trends in how these regimens might be used.

In Part 2 of the ongoing series, we spoke with another CLL expert and explored promising new and earlier agents in development for a different perspective on how outcomes might be improved further.

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Targeted therapy and Chemo-Immunotherapy in CLL

At last December’s 2016 annual meeting of the American Society of Hematology, one of the areas that attracted attention was the latest clinical data on the treatment of chronic lymphocytic leukemia (CLL).

ASH 2016 in San Diego

In recent years, we’ve seen tremendous advances in the field with several new agents approved such as obintuzumab, ibrutinib, idelalisib, and venetoclax. There are also new treatment options available for CLL patients with high risk disease such as 17p deletions (Del17p).

Other new targeted therapies such as acalabrutinib are now in clinical development, plus we have CAR T cell therapies and combination strategies also being evaluated in the clinic.

So what was the hot news from #ASH16 in CLL?

  • Does chemotherapy still have a role or is it a targeted therapy world?
  • Are we further forward towards a cure?
  • Have we worked out how to identify those at risk of relapse?
  • Will CAR T cell therapy be a game changer in CLL?
  • Is financial toxicity going to be an issue with combination strategies?

BSB interviewed two experts in CLL while in San Diego who kindly shared their thoughts on which CLL data impressed them at the ASH annual meeting and discussed some of the big strategic issues facing the field right now. These interviews are being posted in a two-part series.

Part 1 today answers some of the questions highlighted above and explores the changing face of the broader CLL landscape.

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San Diego – after “Flying Friday” where I flew from Munich to San Diego, Biotech Strategy Blog coverage of the 2016 annual meeting of the American Society of Hematology (ASH) is now done for another year.

Downtown San Diego during ASH 2016 With over 27,000 attendees – it’s the largest ASH annual meeting I’ve seen in 20 years of coming here!  ASH is definitely the pre-eminent global meeting for hematology and blood cancers.

As you might expect, the thought leaders at this event are super-busy, but we’ve already managed to catch up with a few, and we’ll be rolling out interviews in the “post-game show.”

Subscribers have been asking what’s really hot at ASH this weekend, so reflecting my interests and the sessions I went to, here are my seven highlights/learnings of ASH 2016 (so far). There’s a lot more data to come!

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Post 2016 US Election, we move on and get back to business with an in-depth review of some new science and clinical data.

ash-2015Yes, it’s time for another Bushidō – “Way of the Warrior” – guide to the key ASH abstracts!

Here we focus on acute myeloid leukemia (AML), a difficult and challenging disease to treat with a high unmet medical need for new effective therapies.

In this Preview we look at key companies in the AML space, as well as a look at what’s happening in classic targets and also some new ones that are receiving notable attention, both preclinically and also in the clinic.

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The BET Bromodomain market is a meaty epigenetics topic we have followed for several years now, including a look at the space back in 2013 on the old Pharma Strategy Blog (Link). The last update on this was ironically at AACR last year when we discussed MYC and bromodomains (Link).

Nawlins Mardi GrasIn a remarkable tale of two cities in real life, two companies we discussed in those posts – Constellation Pharma and Tensha Therapeutics – have had markedly different fortunes since then. Roche decided to end their collaboration with the former and went on to acquire the latter instead.

Since we first wrote about bromodomains and BET inhibitors, the niche has exploded in a wildly stunning way… More drugs in the pipeline, more tumour targets being explored, and even novel combinations being evaluated preclinically for synergistic or additive effects. Even I was surprised by how competitive this niche has become based on the offerings at AACR this year.

With all the wealth of new data at the AACR annual meeting and also some other recent presentations I’ve attended elsewhere, it’s time for a more in-depth look at the BET/Bromodomain landscape.

Who are the new players, which tumour targets are now being evaluated, which combinations might be useful?

A word to the wise – this is neither a nerdy science post nor a comprehensive literature review – instead we take a look at the emerging landscape from a new product development perspective.

Science has been absolutely critical to success in all of the cancer therapeutics from targeted therapies to immunotherapies that have emerged in the last decade.

It really doesn’t matter whether you come from a marketing and commercial organisation or the investment community – if you want to make great decisions, you need to understand the basics of the science underpinning the R&D, where the strengths and weaknesses are. The alternative is play Roulette and put everything on Black 11 as a euphemism for whichever company/product/target you have an interest in.

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Miami Beach

Miami Beach Lifeguard Tower

This week I’ve been at an American Association for Cancer Research (AACR) conference in Miami on “Targeting the Vulnerabilities of Cancer,” part of their Precision Medicine Series (Twitter #AACRpm16).

What’s interesting about AACR small specialist meetings is as well as listening to high quality talks, they create a relaxed atmosphere for networking and catching up with experts informally. The conference this week was relevant to anyone with an interest in cancer drug discovery.

Dr Bernie FoxAlthough cancer immunotherapy remains the hottest topic in cancer drug development, we shouldn’t forget that there are other therapeutic targets worth exploring; several potential new opportunities were highlighted in Miami.

As readers know we don’t share unpublished data on the blog, so what I’ve done is provide a top-line summary of some of the strategic themes and key take homes I took from several of the presentations.

As an aside, If you haven’t already done so, do listen to the latest episode of the Novel Targets podcast – Of Mice and Men – it features excerpts of interviews recorded at the recent AACR annual meeting in New Orleans. I was surprised by some of what I heard!

For more information on forthcoming AACR meetings and workshops, check out the events calendar on the AACR website.

If you would like to read my commentary from the AACR Precision Medicine Conference in Miami on Targeting the Vulnerabilities of Cancer, subscribers can login below or you can purchase access.

This week certainly turned out to be a defining tale of two drugs with a chequered history…

Lion DancersFirst off, the FDA approved AbbVie/Genentech’s venetoclax, now known as Venclexta, in a subset of CLL patients with 17p deletions. These patients have a historically poor prognosis and the approval goes some way to addressing the high unmet medical need.

Secondly, another biotech company, Clovis Oncology, got slammed by ODAC with a 12-1 vote to wait for phase 3 data from the TIGER-3 trial for rociletinib to better determine the efficacy:safety benefit profile.

For a long while it seemed that AbbVie had nothing but toil and trouble over the tumour lysis syndrome (TLS) issues giving them some significant challenges to overcome, while Clovis were one of the new darlings of Wall Street.

In the final dash to the market, the tables were turned almost at the 11th hour and fortunes stunningly reversed.  Yet a mere eighteen months ago, few industry watchers would have predicted the difference in outcomes.

In our latest AACR Preview series, we take a look at Bcl2 inhibition and where some of the emerging opportunities might lie based on new preclinical research that is being presented here in New Orleans this weekend.  It makes for interesting reading.

While one tiger is licking its wounds, another is smacking it chops at what the future might hold for new combination approaches; how the tails have literally turned.

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ASH15 LBA Session

ASH 2015 LBA Session

The annual meeting of the American Society of Hematology (ASH) has a few quirks compared to other meetings. One of these is that all the “Late Breakers” are presented together on the last morning of the meeting.

It’s a rather unfortunate time given many have already headed back to their busy clinics or left for SABCS in San Antonio and ‘late breakers’ by definition, often offer new data that’s really noteworthy.

The result can also be a bit of a hodgepodge session that you have sit to listen through to get to those presentations you really want to hear.

At ASH this year there were two late breakers on new treatment options for CLL patients with a 17p deletion (Del17p). This is a pretty challenging group to treat.  Although ibrutinib is indicated for this patient group, many sadly relapse. There’s an unmet medical need for new treatment options. At ASH we heard data for idelalisib (PI3K-delta) and venetoclax (Bcl2).

After the session, I briefly spoke with Dr Kanti Rai (New York) for his reaction to the data. Dr Rai (pictured below) received the 2014 Wallace H. Coulter Award for Lifetime Achievement in Hematology.

Dr Kanti Rai receives 2014 ASH Lifetime Achievement Award

Dr Kanti Rai receives 2014 ASH Lifetime Achievement Award

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In the last of our American Society of Hematology (ASH) 2015 annual meeting previews, we take a broad look at a host of intriguing abstracts in a variety of different topics that haven’t been covered in the rest of the series.

We also take a look a drug that has had a chequered history in the past, namely venetoclax, from the folks at AbbVie and Genentech. Is this a dud destined for dog drug heaven, or will it make a roaring comeback, breathing fresh life into hematologic malignancies such as chronic and acute leukemias, lymphomas and even multiple myeloma?

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ASH 2014 San FranciscoThe 2015 annual meeting of the American Society of Hematology (ASH) (Twitter #ASH15) in Orlando has a bumper crop of interesting data.

ASH is one of the my favourite meetings on our conference calendar. I’ve been attending for many years, starting with when I was a commercial account manager for Hematology, Immunology, Transplantation and Oncology in the UK, then at Novartis in the US, when I was part of the team that brought Gleevec to market.

Hematologists make for an interesting group of people to talk to!  They are very focused on the science behind a disease and how translational research can move the needle forward and generate better outcomes for their patients.

As part of our continuing preview of #ASH15, I’ve taken a quick look at the late-breaking abstracts that were released today. We will have more in-depth coverage after we’ve heard the data presented in the 7.30-9.30 am session on Tuesday December 8.

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If you’re not already a subscriber, but what to know “What’s hot at ASH15?” then you should purchase access.  Additional ASH previews are already planned.  By the time you’ve read them, you should “hit the ground running” in Orlando.

As Warren Buffett famously said, “Price is what you pay. Value is what you get.” I couldnt agree more. We have subscribers who just purchase our ASH coverage every year, so do check it out if you haven’t done so already.

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