Biotech Strategy Blog

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

Posts tagged ‘AbbVie’

Virtual meetings mean we miss the fun of German pop-up sausage stands and focus solely on the new emerging clinical data!

EHA25 Virtual, Not-In-Frankfurt – There’s a lot of commercial interest in CD20 x CD3 bispecifics, and in this post we’re taking a look at some of the latest clinical data presented at recent ASCO and EHA virtual meetings. Companies mentioned include Regeneron, Roche/Genentech, Genmab/Abbvie, Xencor, and IGM Biosciences.

Any analysis of a rapidly evolving and fast-moving landscape only represents a snapshot in time at the point it was taken, and this post is not intended to be a comprehensive landscape report, you’d pay a lot more than a yearly sub to BSB for that, but we’ve been following the field, and there are some trends emerging.

What makes it interesting is there is some nuance required in the interpretation of data, and with that in mind we spoke to an investigator at the forefront of clinical research who has done trials with several of the CD20 x CD3 bispecifics in development; the insights were quite illuminating.

This post offers an update on the CD20 bispecific landscape, analysis of some of the recent data at EHA and ASCO, as well as expert opinion, what more could you ask for?

To read our latest expert interview, and gain insights from our oncology analysis and commentary around data emerging from the ASCO and EHA virtual meetings, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Last October I posted two updates on small cell lung cancer (SCLC). One explored the broad SCLC landscape, while the second was a detailed analysis highlighting the red and green flags to watch out for in the Rova-T TRINITY study.

My sombre conclusion or prediction, if you will, was not particularly well received at that time:

“My sense is that the median PFS and OS in the allcomer ITT population will remain modest and in line with what we might expect from historical chemos in 3L SCLC.”

Dismal happenings are to be expected…

This morning AbbVie announced that they will not be filing for accelerated approval of Rova-T in 3L SCLC based on the interim analysis.  In other words my expectations for this trial were met, although there are many who will be very disappointed at the results.

What matters though is not just how disappointing topline results might be per se, but why they occurred, what we can do about it, and most importantly, where we go next.  There’s a lot more to this than might initially be obvious from the press release.

That’s what this new post is all about… first a post mortem, then the obstacles to be addressed, and finally, what we can look forward to in SCLC…

On a happier note: there may be some surprises ahead!

To learn more and get a heads up on our latest oncology insights, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Yesterday in part 1 (Link) of our latest mini-series, we looked at the SCLC landscape and some of the key background issues to think about.

This time around in part 2 we drill down focus more specifically on Rova-T, including physician and patient sentiments and in particular, what to watch out for with the upcoming phase 2 TRINITY readout.   There’s a lot to consider here so we’ve broken the analysis down to five key areas.

Mystic Meg is also back with her canny predictions – what does the crystal ball portend for Rova-T and the TRINITY trial?  Caveat: she’s been on a tear of late; this situation will not continue forever.

To learn more insights on this intriguing topic, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

Many of the questions we received from BSB readers this month was a plea from several folks to answer numerous queries about small cell lung cancer (SCLC) and the anti-DLL3 ADC, Rova-T, in particular.

Of course I’m happy to oblige, but this was way too big a topic for inclusion in Friday’s mailbag.

Cornish Tin Mine

What makes a lot more sense here is a short two-part mini series where we look at the dismal landscape of the disease and then consider the red and green flags that arise from the Rova-T development.

With the interim results expected from the phase 2 TRINITY trial in 2H17, this is a timely moment to sit down and reflect on what to expect.

In the first part of the series, we walk through SCLC as a disease, including what is known and what to consider when contemplating a new therapy here.

In the second part tomorrow we will focus more specifically on Rova-T and what to watch out for.

So let’s rock and roll with a look at the SCLC landscape…

To learn more insights on this intriguing topic, subscribers can log-in or you can click to gain access to BSB Premium Content.

This content is restricted to subscribers

It’s Wednesday at the 2017 JP Morgan Healthcare Conference and the last full day of the meeting. 

SF Streetcar at Pine StIt’s also our last day for a rolling blog; we hope you’ve enjoyed our coverage and commentary this year.

If you want to catch up on what we’ve written about, do check out our posts form Day 1 (Link) and Day 2 of JPM17 (Link).

Yesterday also included some thoughts on the latest Merck pembrolizumab filing announcement in 1L NSCLC, which has certainly had a dramatic impact on the market, even for big pharma (MRK +$4.9B, BMY -$3.3B).

Companies we’ve covered so far include: Celgene, Incyte, Seattle Genetics, Clovis, Puma, BMS, Five Prime, Nektar, Juno and others.

Subscribers can login to read more

This content is restricted to subscribers

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.

To learn more insights, subscribers can log-in

This content is restricted to subscribers

Chicago ArchitectureChicago – the ASCO 2016 annual meeting is in full swing. This is the third and last day of our rolling blog where we’re providing updates with top-line commentary throughout the data.

If interested, you can also check out the many updates from Day 1 and Day 2.

There’s a lot happening at ASCO today, including a presentation by Vice President Joe Biden later this morning. Allow extra time for security checks if you plan to listen to him in person, and I expect there’ll be delays to the hotel shuttle buses around Chicago as roads are closed to accommodate the VP’s motorcade.

Many people chose not to come to ASCO this year – but it’s turned out to be a great meeting. We’ve heard a lot of new data which are likely to have an impact on future clinical trial strategy, as companies look to bring new products to market in what is a competitive field, particularly in cancer immunotherapy. There are how many PD-1 checkpoints in development now?

A word of warning to the wise – not all these IO molecules are going to win – some are going to fail, some will be useful tools in various subsets and some are going to be new home runs.

If you’d like to read our coverage of Monday at ASCO 2016, you can login if already a subscriber, or you can purchase access.

This content is restricted to subscribers

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.

To learn more about this burgeoning niche in epigenetics, subscribers can log-in.

This content is restricted to subscribers

It’s the end of April and just in time for two important things here on BSB…

Dan Chen and Ira Mellman on Novel Targets PodcastA) Season 2 of our Novel Targets podcast has now kicked off!

The first show (sponsored by Genentech) explores the cancer immunity cycle (CIC), how it can help see the bigger picture and how this framework can be used to help figure out what areas are missing when patients don’t respond to immunotherapy.

There are also predictions about what we will see coming up in the next year – will the crystal ball be accurate – or not?

Crank up the Sonos, grab a coffee, pen and paper – you’ll find the latest podcast show here (Link), which is open access for anyone who wants to listen.

B) Reader Q&A Mailbag: we tackle your latest tough questions that are top of mind and offer insights on the hot topics people want to know about.

We have a broad range of topics to cover today including:

  • The battle for PD-1 sales
  • What are the IO bottlenecks where we can expect to see new research focus
  • Sanofi-Medivation bid
  • AbbVie snapping up StemcentRx

To learn more, Subscribers can log-in or you can purchase a subscription.

This content is restricted to subscribers

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.

To learn more, subscribers can log-in to read our latest article…

This content is restricted to subscribers

Free Email Updates
Subscribe to new post alerts, offers, and additional content!
We respect your privacy and do not sell emails. Unsubscribe at any time.
error: Content is protected !!