Biotech Strategy Blog

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

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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Who’s King of the PARP castle?

After yesterday’s review and expert commentary on the phase 3 PROfound trial presented in the Presidential Session at ESMO 2019, we’re continuing our look at PARP inhibitors in advanced prostate cancer.

Perhaps surprisingly, there were a lot of insights to be found in the posters that were presented and discussed at the meeting for other PARPs in clinical development.

How do these stack up against olaparib? We’re not fans of cross-trial comparisons as they always come with a mandatory health warning, but if you want to consider the emerging landscape, it is important to be aware of the different patient populations, lines of therapy, and details of the trial designs.

For additional perspective at ESMO19, we spoke to a European prostate cancer expert who kindly talked about his clinical practice and also offered insights into a PARP clinical trial he and colleagues presented in Barcelona.

Who will be King of the PARP castle in advanced prostate cancer?

To learn more from our latest oncology conference insights and get a heads up on our latest post ESMO Coverage and reflections, including a specialist thought leader interview, subscribers can log-in or you can click to gain access to BSB Premium Content.

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We’ve heard much about the role of PARP inhibitors in ovarian and breast cancers where there is sensitivity to these agents in women with DNA damage repair defects, but what about advanced prostate cancer?

Following the publication of the phase 2 trial TOPARP in the NEJM in 2015, we’ve been eagerly awaiting the outcome of a series of phase 3 studies with these agents in metastatic prostate cancer in multiple different lines of therapy.

Dr Oliver Sartor at ESMO19

Following on from our daily coverage from ESMO in Barcelona last week where we looked at some of the pros and cons as they appeared during the presentation by Dr Maha Hussain (Chicago) from the PROfound trial, it’s time to share some expert opinions.

The study she presented evaluated the PARP inhibitor, olaparib, versus next generation AR anatgonists abiraterone or enzalutamide in refractory metastatic castrate-resistant prostate cancer (mCRPC).  Interestingly, it soon became rapidly clear that many casual observers missed some important nuances from the myriad of top-line news articles and summaries.

The devil, as always, is in the details.

To further our readers education on this important topic, BSB interviewed a prostate cancer thought leader, Dr Oliver Sartor (right) for his personal perspectives and look at the take homes from the lens of an experienced triallist in this niche.

Let’s see what he had to say about PARP inhibitors in advanced prostate cancer, as well as the PROfound and TRITON studies…

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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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