Biotech Strategy Blog

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

Posts tagged ‘Prostate Cancer’

New developments in Prostate Cancer

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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ESMO18 Live Blog Day 1

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 PARP inhibitors apart

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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Apalutamide is not a winner at ASCO GU

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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GU18 Preview – Promise and Pitfalls Abound

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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Go Forth and PROSPER

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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Report on key data in GU Cancers from ASCO-SITC 2018

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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ESMO17 Day 4 Highlights and Lowlights

Greetings from continental Europe!

ESMO Madrid Conference Center

We have a LOT of data to discuss today from ESMO and have also included an interview with one expert that was conducted under embargo on an important topic.

Of course, the usual in-depth analyses on new targets and early compounds in development will duly follow in the post-meeting output, but there’s plenty of practice changing data to consider and also some results that may trigger alternative thinking from where we are now.

We also received questions from BSB readers on certain trials and some of these are answered in today’s update on the road…

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Going Beyond PARP in DNA Damage Repair

We now turn our sights to targeted therapies and DNA Damage Repair (DDR). This is an important topic that has seen much focus in ovarian cancer of late and will likely see renewed interest in breast cancer at the forthcoming ASCO meeting next month. As we segue from one set of conference coverage to the next, there is inevitably going to be overlap, which is a good thing here as it helps with background and preparation in getting up to speed.

There is no doubt that DDR has had a bit of chequered history over the last decade, whether it be the spectacular (and sadly predictable) flop of Sanofi’s iniparib in triple negative breast cancer (TNBC), the negative ODAC incurred by AstraZeneca’s olaparib in ovarian cancer, or AbbVie’s more recent veliparib failures, to the much more positive events such as three PARP drugs now approved in different lines of therapy in ovarian cancer (olaparib, rucaparib and niraparib).

If ever there was a niche for the roller coaster ride that is oncology R&D, it has to be PARP inhibitors.  There’s much more to DDR than just PARP though.

Indeed, there are multiple intriguing targets to explore and also the potential for combinations with cancer immunotherapy approaches that may yield encouraging results in the future.

Can we go beyond ovarian cancer into other tumour types and if so, which ones look encouraging and how woluld we go about exploring those idesa? What makes one approach more successful than another?

Here we explore the world of DDR through the lens one company’s approach and look at what they’ve done, where are they now and where they hope to be. It certainly makes for an intriguing and candid fireside chat.

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How do we get cancer immunotherapy to work in Prostate Cancer?

Dr James Gulley is Chief of the Genito-Urinary malignancies branch and Director of the Medical Oncology service at the National Cancer Institute (NCI) in the National Institutes of Health. He’s a world-leading GU cancer expert and at the forefront of pioneering research to make cancer immunotherapy work in prostate cancer.

We last spoke to him at ASCO 2015 (See post: The future of prostate cancer immunotherapy).

Almost two years on, and new research by Dr Gulley and colleagues from the NCI shows that the STING pathway may have an important role to play in prostate cancer immunotherapy. Activation of this pathway through a novel mechanism could turn a cold non-inflamed tumor into a more inflamed or hotter one in men with advanced prostate cancer. How cool is that?!

At the 2017 annual meeting of the American Association for Cancer Research (AACR) that was recently held in Washington DC, Dr Gulley graciously spoke to BSB about some of the novel trials that are underway at the NCI, with the aim of making cancer immunotherapy work in men with advanced prostate cancer.

Dr Jim Gulley, NCI at AACR17

This is the seventh expert interviews in our series from AACR17 where we explore the conundrum:

How does Dr Gulley plan to light the immune camp fire in prostate cancer?

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