Biotech Strategy Blog

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

Posts tagged ‘Breast Cancer’

Sadly not the #blisterwalk this year

Not in Chicago – Breast cancer has been a hot topic again on several fronts after a bit of a lull on the R&D front.

Writing about such trials across ESMO Breast, ASCO and the second AACR meeting is all very well, but what about some KOL commentary and reactions to some of the data we get to see?

If this has been a burning question for you, this is a handy article to catch up on. Of course, to be clear – not all the trials will be positive or biomarker analysis helpful, so here we tackle the issue and look at what’s what though the lens of a specialist…

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Time for some reflections from ASCO

Many eyes at ASCO this weekend will be eagerly turned towards the plenary session on Sunday and the stunning osimertinib data in the ADAURA (adjuvant osimertinib therapy for EGFR positive disease) where 69% were stage II/IIIA and for those patients, DFS HR was 0.17 with a 2 year DFS rate of 90% (only 44% with placebo).

There is no doubt this is the data of the meeting for me – when was the last time we saw a hazard ratio of 0.17?! More on this development after the data has been presented.

Beyond the plenary there are plenty of interesting studies to discuss and ponder at various stages of development. Over the next couple of days a number of other stories and interviews will be also posted.

Here, we provide an update on one of the early drug development stories we’ve been following longitudinally over the last five years from preclinical through to the clinic and offer some reflections on progress to date.

A KOL interview and commentary are included as well…

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This weekend in the oncology conference calendar saw the ESMO Breast meeting take place.

The event was originally planned as a live event in Berlin – sadly with the pandemic it ended up as a virtual meeting on Central European time, yet you can still imagine the Berlin bear welcoming everyone regardless of format!

This is a good time to take off we we left off last week with our SERD landscape review since there was some new clinical data presented in this niche, as well as segue to the ASCO meeting on Friday where other companies will also be showcasing their early data.

Aside from SERDs, there were plenty of other highlights and commentary to consider in advanced breast cancer.

Here we explore some of the findings and offer some context for at least one commercial showdown…

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First in class or best in class?

Which paths will ultimately lead to success with novel targeted therapies?

Ah this question often seems a perennial one to consider at AACR annual meetings – and this year is no different in this respect.

Personally, to me, it doesn’t really matter what you claim aspirationally based on preclinical or even early phase 1 dose escalation data because… a lot can happen between then and later registrational studies.

Think about it carefully – weak efficacy, wrong tumour selection or setting, adverse event profiles, even narrow therapeutic windows can all too soon interfere and play havoc like a wrecking ball with many a well intended clinical program, especially once you start looking at combination strategies!

No, it’s not as easy as it looks sometimes.

In our latest AACR Preview series, we take a look at a number of targeted agents in development, many aimed at novel targets at are not run-of-the mill…

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It’s time to talk about new developments in breast cancer.

@3NT with Dr Dennis Slamon at ESMO19

This week we will be featuring thought leader interviews with two breast cancer specialists as we look at new data in different subsets of this disease, in both early and metastatic settings.

We like to ring the changes with invited guests on BSB who comment on trial results and offer broader perspectives on their specialist field as well.

One expert is someone neither of us has ever interviewed before, while the other returns for an update on an early trial that is showing promise. Both interviews were conducted under embargo ahead of their presentations in Barcelona.

One of the myriad of challenges in oncology R&D is the tendency to begin exploration in the most advanced form of the disease with monotherapy to determine single agent activity and then work up to earlier lines of therapy with combinations evolving over time.

While it is always good to see proof that people are living longer with particular approaches, there is a real need to keep one’s eyes out on the horizon for new developments that may extend overall survival further.

What should those regimens look like and what are rational choices based on the underlying biology of the disease rather than being explored because that’s what a particular sponsor happens to have in their pipeline? We were delighted to have the opportunity for a much broader discussion some of these opportunities with today’s key opinion leader, Dr Dennis Slamon of UCLA, who presented data in an ESMO Presidential symposium and also talked about other topics in breast cancer research with BSB.

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Padstow, Cornwall – It’s May Day or ‘Obby ‘Oss, as it’s known locally in this little corner of south west England.  The quaint festival means that it’s the biggest day of the year as over 30,000 people crowd into the tiny fishing village.

Obby Oss Blue

Centuries old traditions are still alive and well in this part of the country and the big question of the day (are you red and white or blue and white?) is a far cry from the complex high tech world of cancer research.

Still, with all the time and attention focused on immunotherapy and targeted therapies of late, it is all too easy to forget what’s happening on the epigenetics front, which is quite a bit in practice.

We often see random allcomer approaches to clinical trials, which are find for phase 1 studies where you want to gather data on responders and non-responders in order to conduct PK/PD and immune profiling, as well as biomarker and signature development, but a potential recipe for disaster in phase 3 if you have no idea exactly what’s driving the efficacy since you can all too easily end up with unbalanced arms that you didn’t control for and thus skew your survival curves in a way you didn’t anticipate.

Why on earth would you use a targeted therapy in an untargeted fashion? Hmmm obvious question and yet, many companies still do this all the time.

There are some biotechs out there, I’m pleased to say, who do conduct extensive translational and biomarker research.  Obviously finding those markers is a lot more tricky than choosing red or blue.

One biotech company we have been keenly following for a while is Syros.

We first wrote about them in Spring 2014 and now, five years on, I thought it would be a nice idea to catch up with one of their founders and learn more about the science underpinning what they’ve done and where they’re going with future projects. Not only do they invest in smart medicinal chemists, profiling and translational research, but they also seek to identify rational reasons why people respond to their compounds.

The answers were rather interesting and there’s quite a bit that readers might be curious to learn more about…

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San Antonio – As the Fall conference season is rapidly drawing to a close, it’s time to highlight some key findings on breast cancer from the San Antonio Breast Cancer Symposium (SABCS).

In this in-depth post where we explore the breast cancer landscape in terms of updates on key trials that stood out as well as highlights from several thought leader interviews on translational and clinical aspects of the disease.

We also explore some important biological and biomarker aspects to think about in future IO trials.

Are you ready? Let’s roll!

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View from Stars and Stripes life guard hut on Miami Beach

Our latest article is part Journal Club entry for August, part look back at some data from AACR and ASCO plus a part look at a relatively new target from an obscure biotech that caught my attention recently.

To do this, we pose three critical questions and attempt to answer them.

The targets and markers chosen for review here may well surprise a few people.

If we want to understand how to help more people respond to cancer immunotherapy then we need o understand the underlying biology and the tumour microenvironment in greater depth than we currently do.

Gradually, we are getting more clarity on a few areas as new data is being published…

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Picking a PARPi – what can the biology tell us?

One of the really interesting questions I recently received from a BSB subscriber related to PARP inhibitors – they asked whether the therapies are all the same and can be considered interchangeable as a class?

Around the same time, another reader wrote in asking if there was any new information on what’s happening with PARPi combinations in breast or ovarian cancers?

This got me thinking as there has actually been some useful preclinical and clinical studies reported on both fronts that at least begin to open our eyes to new information based on research that has been reported in several places.

Thus I thought it would be useful to summarise the data and take a look at what we learned in the process.

Fair warning – some of the findings turned out to be a little bit more surprising than you might normally expect to see…

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It’s one of those truly crazy busy times of the year with no less than three cancer conferences going on this week alone in different cities and time zones. I’ve also been busy scheduling and conducting phone interviews for these events.  More than once have I dialled the wrong number or access code or got briefly confused by time zone changes (CT and CEST?!) and misread the interview at the wrong time… and was that 4.30pm ET or CT?

River Walk, San Antonio, Texas

One of those… If it’s Tuesday it must be Belgium moments to be sure.

Thankfully, everyone has been very thoughtful and helpful and I haven’t managed to get the expert names incorrect (yet)!

Today, I want to take a break from the ASH17 coverage and switch horses from hematologic malignancies to breast cancer and from Atlanta to San Antonio, as there is some important new data emerging from the Lone Star state.

In particular, one of the top posts of 2016 on BSB was on CDK4/6 inhibitors so it’s time for an update on this and some other key studies!

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