Biotech Strategy Blog

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

Posts tagged ‘obinutuzumab’

Innovator’s Dilemma – Promise and Potential of Bispecific Combination Strategies

Imagine a scenario… a symphony of therapeutic agents working in harmony, each contributing its part to achieve remission in even the most refractory hematologic malignancies. Yet, as with any great orchestra, a poorly tuned instrument – or in this case, a poorly considered combination – can disrupt the entire performance.

Bispecific T cell engagers have emerged as new virtuosos in cancer therapy especially in refractory settings involving hematologic malignancies such as lymphomas and myeloma, although their integration into combination regimens may be as challenging as it is promising.

Don’t be caught napping though!

In our latest ASH analysis, we’ll explore how some of these combinations perform, where they falter, and whether they can truly expand the therapeutic repertoire or simply shrink the index of possibilities.

In this review we will explore half a dozen different bispecifics when given in combination with an additional therapy to determine if:

  • They add anything to hematologic malignancies over what we would expect for monotherapy
  • Whether or not they shrink the therapeutic index
  • Whether anything else of note stood out (positive or negative)

If they fail on the first and negatively impact the second then they are highly unlikely to be a candidate for further clinical development!

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The trouble with crowds

How do we go about distinguishing one therapy from another in an emerging niche?

It’s been fascinating to see many companies in the IO space trying to pivot from oncology to autoimmune disease, regardless of whether they have a CD19 or CD20 T cell bispecific or CAR-T cell therapy.

Someone presents some initial evidence of activity and suddenly, Bingo!  Everyone else rushes to try it out too.

It reminds me of those old medical jars at apothecaries in the 1700-1800s, like the one in Imola (right), which still stands today.

How do we pick out one from another though?

The obvious answer is… it depends.  On the data collected by disease setting, the line of therapy, disease burden, and so on.

This is going to take some time to gather before the dust settles.

In our latest review we chose eight different approaches and put them through their paces for a careful look at the evidence.

Did anything stand out?  Yes, it did…

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A critical review of bispecific antibodies at ASH20

We are big fans of the American Society of Hematology (ASH) annual meeting, it certainly is the global meeting for hematology! The quality of research presented is very high; it’s where you see groundbreaking and practice changing hematology data, sometimes from unexpected sources.

Last year brought us long lines, crowded escalators, and jam packed halls, especially for the niche sessions.  It’s hard to imagine any of these in pandemic these days, especially if someone were to start suddenly coughing and sneezing in the seat behind…

A bit of nostalgia from ASH19: Up close and personal

Will we all be together again for #ASH21? According to virology experts, we’ll need 70% of people (around the world, not just in one country!) to have had a COVID-19 vaccine before we can lower our masks and do away with social distancing.

Even if 70% of health care professionals are vaccinated, a not unrealistic figure if you look at the flu vaccine uptake, going to an in-person meeting means you still have to navigate the cumulative risk associated with airports, flights, hotels, ground transportation, plus eating out in an urban environment where the very visible inequality that exists in America means it is highly unlikely everyone you may come into contact with, directly or indirectly, will be vaccinated.

There’s also the uncertainty of how durable any vaccination is, raising the prospect that any COVID-19 vaccination is unlikely to be “once and done” – will we all need boosts six months later? The logistics for all of this are just mind blowing.

Despite the exhortations from ASH leadership that they look forward to seeing us in Georgia next year at #ASH21 and we should all plan to be there, as things stand we don’t recommend booking your flights to Atlanta and #ASH21 just yet.

BSB expects 2021 to be another year of virtual meetings!

Meanwhile, on with the business of exploring the emerging data from ASH 20.

In this latest post, we are highlighting a few of the presentations that caught our attention on the various bispecific antibodies and T cell engagers in advanced lymphomas and multiple myeloma…

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The science behind the venetoclax clinical trial strategy

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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Promising new agents to watch out for in Chronic Lymphocytic Leukemia

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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The Changing CLL Landscape Part 1

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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LeonardList showcases 10 Lymphoma Abstracts at ASH16

John P. Leonard, MD is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell in New York. He’s a Lymphoma specialist.

Dr John Leonard at ASH16

Like many hematologists, he’s embraced Twitter as way to share his expertise with others in the hematology community. You can follow him at @JohnPLeonardMD.

Over the last couple of years prior to the ASH annual meeting, Dr Leonard has highlighted 10 lymphoma abstracts that caught his attention. You can tell he gets excellent social media pickup by the fact he’s even generated a hashtag to make them easy to find: #Leonardlist and other hematologists generate conversations around his eagerly awaited picks:

In case you missed them on Twitter, and in the spirit of David Letterman, Dr Leonard took me through this year’s #LeonardList and thoughtfully explained in detail why each selection made the cut… for oncology watchers, the why is often more important than the what.

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7 Things I Learned at #ASH16

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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ASH16 Abstracts are out! So What’s Hot at ASH16? My Initial Impressions

The abstracts (apart from the late-breakers) for the 2016 annual meeting of the American Society of Hematology (Twitter #ASH16) went live at 9am ET today. Link to 2016 ASH Abstracts.

ASH16 takes place in San Diego from December 3-6.

View of San Diego from ASH 2011In this initial post, I’m sharing my first impressions of what may be some hotly contested trials at ASH16 in San Diego, as well as a few intriguing abstracts with combination data that caught my attention.

With over 3,000 oral and poster presentations, all typically of a high quality, this by post by definition, is a highly subjective one.

After we’ve had more time to process the data, further ASH16 Previews will roll out over the next few weeks highlighting more key abstracts to watch out for by tumour type or treatment modality.

In-depth commentary and analysis will follow after we’ve heard or seen the data presented at the meeting.

I’ll be flying to ASH from the EORTC-NCI-AACR Molecular Targets meeting. Do say “hello” if you have plans to be in Munich or San Diego.

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Will venetoclax impact in hematologic malignancies

A couple of years ago we had a lot of fun here on BSB following the progress of ibrutinib (Imbruvica), obinutuzumab (Gazyva), and idelalisib (Zydelig) in CLL and indolent NHL.  It seemed back then that the stunning trio were the hot topics for some time at ASCO and ASH meetings.  Exciting times!  All three target different entities (BTK, anti-CD20 and PI3K-delta) and made it past the tape to market, with Gazyva leading, Imbruvica a close second and Zydelig a slightly more distant third.  I was reminded of the race again over the last week or so as the 4Q earnings were announced, with Pharmacyclics reporting almost $500M for Imbruvica last year and estimating sales to hit $1B in 2015.  In contrast, Zydelig revenues for 2014 were $23M, reflective of their much later market entry in the US.

Still, that was a pretty impressive set of drugs all in development at the same time.

Two other agents we also reported on regularly were Infinity’s IPI-145, a PI3K delta-gamma inhibitor, and ABT-199/GDC-0199 (now known as venetoclax).  I haven’t heard much about the former of late, but after a few missteps, the next big question to consider is whether venetoclax is coming back strongly or destined for dog drug heaven?

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