Biotech Strategy Blog

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

Posts tagged ‘Prostate Cancer’

San Francisco!

San Francisco – It’s time to switch horses for some the latest conference coverage and explore some important new findings emerging from the genitourinary world of bladder, prostate, and renal cell cancers at the ASCOGU specialist meeting held late last week.

Not that many years ago, much of this niche was dominated by numerous updates in prostate cancer, with little good cheer to write about on the other two cancers – how things have changed in such a short time!

This year there’s plenty going on in all three categories, I’m pleased to say.

Here we focus on several important trials or targets and explain why they matter and what’s significant about the findings…

Some of the agents or trials selected here are likely to receive more attention going forward as more data become available, so it behooves us to set the scene now.

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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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We’ve been writing about PARP inhibitors since 2006!  Who knew this target would have multiple legs over a dozen years on?

Barcelona

In this post we’re taking a look at some of the noteworthy presentations at ESMO19 around targeting DNA damage repair (DDR) and how they act through synthetic lethality and/or the generation of immune response to kill cancer cells in GU cancers.

It’s a fascinating area where we are seeing convergence between immunotherapy and genomic instability, one of the hallmarks of cancer.

The abstracts for ESMO19 are not yet available, so in this post we’re only providing context and setting the scene for some of the presentations we are looking forward to, as well as raising some key questions that we hope will be answered in Barcelona.

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At one point not too distant in the past, all the big news seemed to flow out of advanced prostate cancer with abiraterone and enzalutamide vying for attention, followed by occasional news on ARN–509, ODM–201, galeterone (remember that one from Tokai with all the AR-V7 kerfuffle?), radium Ra–223 dichloride, cabazitaxel, denosumab, ipilumumab, PROSTVAC, brachyury, and a few others. Predictably, not all were successful, and the count is still out on some.

San Francisco

In our latest conference coverage, we take a look at what we can learn from riding the prostate cancer train at ASCO GU ahead of the presentations in San Francisco tomorrow.

We will be updating this review as more data become available with the presentations, so do grab a cup of joe and settle down for some interesting reading ahead of time… this should get you all up to speed on the journey there!

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Munchen – ESMO18 is finally here, sadly not at the same time as Oktoberfest!

The last time I was in Munich (for the Triple meeting in 2016 where TLRs and RIG-1 were a thing in early drug development), getting to the conference centre at Messestadt West from the Hilton was an absolute doddle – fast and efficient, as you would expect from the Germans, with only one simple change and little waiting around on chilly platforms.  Getting back in the rush hour was another matter entirely, as one was either over tired or the trains were mostly going out of town not into it, and to add insult to injury it was bitterly (freezing) cold in November.  Yes, I was on a train on the right line, but heading in the wrong direction at least once, sigh.  I blame the distorted announcements squawked in German only, apparently alerting unsuspecting punters of crucial platform changes 😉

For those of you heading to the conference centre by train/subway, look out for the red U2 line, direction Messestadt Ost at the end of the line:

En route to Messestadt Ost at the end of the red U2 line

Meanwhile, on to the crucial business matters… we usually do live running daily blogs at JPM in January and ASCO in June, where they are most popular, there’s a massive amount of news and data and thus well received.

At ESMO this year there is a tremendous amount of data to uncover, review, and discuss, so it seemed like a good opportunity to repeat the experiment, not least because there will be too much information to summarise at the end of each day, plus sleep is always a premium at cancer conferences.

This year will be jam packed with KOL interviews, trial readouts and analysis, commentary and perhaps even the occasional lighthearted whimsy… rock on!

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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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Red Bull Air Race NYC

San Francisco: Today at the 2018 American Society for Clinical Oncology Genitourinary Cancer Symposium, commonly known as ASCO GU (Twitter #GU18), Dr Eric Small (UCSF) will present the results of the SPARTAN phase 3 trial (Link to abstract):

SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).

Despite the fact this is a positive trial and apalutumide will most likely gain regulatory approval for this indication in the United States, the data presented at ASCO GU is not a winner when viewed in the broader context of the prostate cancer landscape.

BSB subscribers can login to understand why, and also gain the perspective of a global thought leader familiar with both the SPARTAN and PROSPER trial data.

On a day when J&J have just announced that abiraterone (in combination with prednisone) provides a new treatment option for patients with metastatic high-risk castration-sensitive prostate cancer based on the results from the randomised phase 3 LATITUDE study, everyone’s attention is focused on the battle between SPARTAN (apalutamide) and PROSPER (enzalutamide) in M0 disease.

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It’s that time of the year again already… the ASCO GU Preview series!  The good news is that there is a bumper crop of intriguing data to discuss this year.

Golden Gate Bridge, San Francisco

With the ASCO embargo on the GU Symposium in San Francisco lifting at 5pm, there’s a lot to consider not merely in terms of the data itself, but more importantly, in terms of a broader context and the landscapes involved in prostate, renal and urothelial cancers.

Here we take a look at some of the key highlights to watch out for and what they mean in context.

A separate post on the phase 3 PROSPER data for enzalutamide in prostate cancer with a discussion on the ongoing enzalutamide/abiraterone/ADT/chemotherapy debate as part of the GU18 coverage is also available.

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The abstract has just been published for the phase 3 PROSPER trial to be presented later this week at ASCO GU in San Francisco (#GU18).

@Daniel_J_George

PROSPER: A phase 3, randomized, double-blind, placebo (PBO)- controlled study of enzalutamide (ENZA) in men with nonmetastatic castration resistant prostate cancer (M0 CRPC).

Earlier today Dr Daniel George (pictured), one of the investigators, kindly spoke to BSB about how he interprets the trial data and what it may mean for the treatment of prostate cancer.

Dr George (@Daniel_J_George) is Professor of Medicine and Surgery, and Director of Genitourinary Oncology at the Duke Cancer Institute.

Should men with non-metastatic CRPC receive enzalutamide in order to PROSPER?

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At the inaugural event in Orlando last year, one of the highlights for me was learning how important CD38 might turn out to be as another immune checkpoint target in combination with other approaches.

This year the meeting moved to the west coast and was held in San Francisco, making it the third one this month after JPM18 and GI18. Indeed, the fourth such event is also rapidly coming up with ASCO GU next month!

So what did we learn this time around? Quite a lot it would seem.

While much of the clinical data of late associated with immune checkpoint blockade (ICB) has been in metastatic melanoma and non-small cell lung cancer (NSCLC), two other tumour types that have received increasing attention in the IO space have been clear cell renal carcinoma (ccRCC) and prostate cancer.

There were a few interesting new things we can learn here…

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