Biotech Strategy Blog

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

About MaverickNY

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Posts by MaverickNY

Cui bono?

Imagine arriving at ESMO19 at the crack of dawn for a press briefing and you’re not presenting until after 4.30pm!

To whom is it a benefit is a fundamental principle in modern day medicine given the often vast array of options that oncologists may have at their disposal.

Conversely, we also need to know nec refert – for whom it doesn’t matter or doesn’t benefit – since we don’t want to over-treat people either.

Between those two extremes might be a couple of sweetspots i.e. one subset who may need a boost from chemotherapy and another in whom chemo plus IO therapy might be a better option.

For sure, we are not advocating that all people with early stage triple negative breast cancer (TNBC) should receive the same thing and certainly not everyone will need checkpoint therapy, no matter what the intent-to-treat (ITT) curves or response rates might try to imply.

There’s a lot of factors to think about and consider so here we look at the KEYNOTE–522 data in neoadjuvant and adjuvant TNBC and unearthed with some solid evidence that might help us understand and think about what needs to be done.

Following on from our in-depth ESMO19 Preview on TNBC and what to watch out for, we also now have a thought leader interview to share plus several other commentators chipping in…

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Gah, if only we hadn’t enrolled allcomers in our study, the differences would have been so much bigger!

Barcelona – This is the day when many people get absolutely walloped by exhaustion at ESMO even after three double espressos – if you’re still going strong then I commend your stamina and fortitude!

This is a big day for several companies with important phase 3 trial readouts due to be presented at the conference today.

One in particular is the phase 3 PROfound trial exploring the role of the PARP inhibitor, olaparib, in HRD+ advanced prostate cancer.

Beyond the top line findings (the PFS endpoint was met) there are a LOT of subtleties and nuances to consider so we have an analysis to share of some of the pitfalls and potential issues that may be missed in the hurly burly and noise.

Are you ready?

There’s a lot to think about today, not just in PROfound, but also quite a few other studies have been put under the microscope too.

Here we go unto the breach, my friends…

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Morning, morning, where’s the strong hot java today?

Barcelona – Here we are on the third day of ESMO 2019 and this is where many presenters and attendees (especially international ones) start to hit the wall with a combination of tiredness, sore feet, late nights, lack of coffee, and jet lag all combine to create a perfect storm of exhaustion.

No matter – the conference schedule marches on!

After the craziness of posting not one, but three, extensive long form posts with commentary and analysis yesterday, I’m delighted to only have to worry about managing the daily highlights today. We’ve also been busy conducting interviews, running round the poster halls and listening to some elegant science talks as well.

If you’ve missed the rest of our ESMO19 coverage, it’s building up nicely so far on this magazine page – do check it out and take your pick of topics to browse.

There are some key phase 3 readouts expected in breast cancer alone, plus a raft of Developmental Therapeutic updates to ponder as well.

As usual, we start off with some known highlights and then move on to updating on oncologic developments that catch our attention through the day.

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The calm before the morning storm surge at ESMO19!

Barcelona – I can’t recall the last time we published three long form posts from a conference before high noon (US time) on the same morning, but that certainly illustrates how busy this year’s ESMO is and there’s a lot more to come yet.

The initial starting coverage for today includes hot topics in ovarian, lung, and colorectal cancers and more will be added in due course.

If you are looking for osimetinib in FLAURA and AMG 510 in KRASm colorectal cancers, click on the BSB log in the top left corner to check out the front page slider for more information on those write-ups and commentary!

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Barcelona – It seems only in only four years we have gone from discussing the phase 1 osimertinib data in EGFRm lung cancer with one Boston expert to reviewing the survival data from the phase 3 study with another expert from the same city… how time flies!

Today was a crazy day with multiple different embargoes lifting at different times so to make things simpler we carved out three different tracks to make it easier for readers to focus and follow the stories they are most interested in.

The KRASG12C clinical trial readouts continue apace with a look at the new non-lung cancer data. That post already went live at 1.30am ET if you’re looking for that evolving story.  The main highlights post with a daily running live blog and multiple updates throughout the day can be found here.

Meanwhile this particular post will contain everything related to osimertinib and the FLAURA trial, as well as where we are on uncovering resistance mechanisms. To get started we have a new press release to look at as well as some independent expert commentary to put the data in context.

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Barcelona – Today is going to be a very long and complex day at ESMO, with a multitude of key data expected from several trials ranging from the phase 1 Amgen data update on their KRASG12C inhibitor, AMG 510, AstraZeneca’s osimertinib in the FLAURA study plus a raft of others, including the phase 3 PAOLA–1 and CheckMate–227 trials.

In order to keep all the information straight and manage the various embargo deadlines at wildly different times, we’re going to break with tradition and post three different articles at different times on KRAS, FLAURA, and the daily running log of various studies and posters that catch our interest. Yes it’s a lot more work, but it’s the only way to manage all the deadlines!

This post will focus solely for the KRAS updates at ESMO19, including the initial data release, the presentation, analyses, and commentary. No doubt that means a series of updates will ensue so do check back regularly or follow the alerts on Twitter via @biotechstrategy.

Let’s roll!

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Old Post Office in Barcelona

Barcelona – After the torrential rains that hit here earlier in the month at WCLC, it’s glorious weather in Barcelona for the 2019 Congress of the European Society for Medical Oncology (#ESMO19).

Each day we’ll be providing highlights from the Congress with news, commentary and analysis from various presentations we’ve attended and thought leaders we’ve spoken to.

This ESMO Congress is a really exciting meeting, perhaps one of the busiest we’ve seen in recent years with multiple sessions in parallel to choose from. There are no shortage of data to discuss and review.  In distant years past, ESMO used to be known as the metaphorical dumping ground for negative trials that undoubtedly got lost in hurly burly – no longer! That changed after they started appearing in the Presidential Symposia and having the spotlight shone on the data. It’s now a much more vibrant meeting for clinical development, with an increasing translational focus thrown in too to explain the why and not just the what.  That’s good news for all of us.

To kick off our daily live ESMO coverage, we begin with sharing some useful insights gleaned from what we’ve heard so far plus more will be added throughout the day as we hear from the educational sessions later…

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It has to be said that this is one of the most jam-packed ESMO schedules that I’ve seen in a while!

Usually one has a few sessions they are interested in and lots of ‘free’ time to conduct interviews. That is definitely not the case this year with even parallel sessions at the same time as the Presidential (plenary) symposia, making for some very hard choices that need to be made.

Barcelona

Immune suppression can take the form of many targets – just taking out one of them may not be enough

As we start to see a renewed focus evolve on how to make immunotherapy work in or help more patients, there has been much attention on what we can learn from the addition of chemotherapy, additional checkpoint targets, immune agonists, various innate targets from KIR and NK cell checkpoints to TLRs and STING, neoantigen and dendritic cell vaccines, a telephone directory of cytokines, oncolytic viruses, etc etc to name a few, all with varying degrees of success.

What about exploring the inhibitory factors that induce immune suppression?  If we can reduce the cloaking and hostile tumour microenvironment, would that lead to more effectiveness with checkpoint blockade?  Maybe, maybe not.

In principle, it’s a sound idea yet these factors are both broad and incredibly varied in scope as a topic as to seem overwhelming at first.  The good news is that there are some emerging targets and hints of activity to come that are slowly beginning to emerge, making ESMO a good place from which to take stock of some new early stage developments.

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The many faces of lung cancer requires an appreciation of nuance in treatment

Barcelona – Many observers seem to so be single mindedly focused on immunotherapies of late that they may well be forgiven that, hey, there’s still much going on the world of targeted therapies!

If there is one thing we can learn from the lung cancer (and CML) communities it is their dedication to identifying resistance mechanisms and along with them, novel targets for subsequent therapy in order to set about improving outcomes for people with the disease.

As a result, lung cancer can now be segmented into many subsets, each requiring careful consideration of appropriate therapy options, not only in newly diagnosed disease, but also what to do with subsequent lines of therapy.

In this review, our third from the WCLC 2019 meeting, we pull together a lot of disparate loose ends on targeted therapies and draw some important themes together…

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A rare dry spell in Barcelona as the clouds roll in bringing yet more rain

Barcelona – While the weather for the World Congress on Lung Cancer (WCLC) has been largely gloomy with plenty of rainy spells, there’s much good news to report on the clinical front.

After yesterday’s review of the Amgen KRAS inhibitor data in G12C mutation positive patients receiving AMG 510, it’s now time to turn our attention to immunotherapy developments with several important trial readouts and in-depth analyses to discuss.

We will be posting a separate summary of the key highlights on targeted therapy, but first let’s consider what we learned on the immunotherapy front, including some of the science behind it all…

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