Biotech Strategy Blog

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

Posts tagged ‘Advanced Prostate Cancer’

Do not feed the alligators is a common sign seen in the hammock areas of Florida where brackish fresh water abounds.

It has always amazed me people might even consider getting close enough to see them since common sense would tell you to beat a hasty and instant retreat from those big toothy maws!

Similarly in biotechland sometimes there are warning signs aplenty and yet people still ignore them, preferring to focus on the good.

Today’s story is a cautionary one where, much like with those “Do not feed the alligators” signs, researchers and investors might be wiser to heed certain warnings rather than focusing solely on what initially appears to be positive data.

Ignore the warning signs at your peril…

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New waves or on the rocks

It’s not that long ago when a certain tumour type saw several waves of promising new agents emerge, quite a few of which made it past the finish line and commercial approval.

These included novel drugs, fast follow-ons, and even me-toos.

The next batch in new development pipelines were not so lucky with a series of disappointing phase 3 misses.

Then radio silence ensued.

As we take another look at this niche, there are a number of early stage agents being put through their paces – small molecule inhibitors, protein degraders, bispecifics, immunotherapies – they’re all there.

Are we going to see some new waves or will they crash and flounder on the rocks?

To find out, we delved into the latest data to determine the current status…

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Science drives oncology new product development and the AACR special conferences are always a good place to look for insights into where the field is both emerging and also going in the future.

At the recent AACR Tumor Immunology and Immunotherapy conference, several presentations stood out for us as being noteworthy for either building on an existing story or the new perspectives they offered, some of which involved new targets we’d not heard before.

In this post, we take a take at some of the data presented, how it builds upon what we already know, and possible directions it may take us in.  After all, the best way to predict the future is to invent it.

It’s time to shine some light on novel targets, biomarkers, and emerging combination approaches…

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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?

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San Francisco

San Francisco – Yesterday at the ASCO Genitourinary Symposium, Dr Kim Chi noted that emerging data suggests that ctDNA appears to give better picture of tumour mutations than biopsy and can also monitor tumour load. This is an encouraging development that may facilitate increased use of the diagnostic as a helpful biomarker of response in clinical trials with immune checkpoint blockade.

We also know that prostate cancer sits firmly in the middle of the now famous Alexandrov and colleagues tumour mutation burden (TMB) analysis, but what factors are important in our understanding of the underlying biology of the disease?

There are many inhibitory factors exerted on the tumour microenvironment and thase may vary not only by tumour type e.g. renal cell carcinoma may have a greater influence from VEGF than prostate cancer, but also in individual patients.

With this in mind, I wanted to explore some new combination data being presented at the meeting, as well as look aspirationally to some potential combinations currently in development that may have escaped many people’s attention.

In this post, we take a look at current and future implications that keen observers should be watching out for…

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Wiesbaden, Germany – Last night Bavarian Nordic dropped the unfortunate news that the phase 3 PROSPECT trial exploring the PROSTVAC vaccine in combination with GM-CSF in asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (CRPC) was futile.

Source: Bavarian Nordic

Once you miss the overall survival (OS) endpoint, that’s it folks – there’s no other choice but to say the therapy failed, harsh though that may sound.

There are, however, a number of important points to consider from here that are worthy of further discussion.

Here, we post an analytical review and look at a number of factors that could have impacted the outcome.  It’s rarely one simple thing because the immune system is highly complex and multi-faceted.

Hopefully there will be important learnings from this study that will advance the IO and prostate cancer fields.

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Coit Tower San FranciscoAt the recent ASCO 2016 Genitourinary Cancers Symposium (ASCO GU) that took place in San Francisco the week before the JP Morgan Healthcare Conference (JPM), one of the noteworthy presentations was on a novel target for men with advanced prostate cancer.

While JPM may have been a “dud” for many, several companies did take the opportunity to update and discuss their corporate strategy going into 2016, which gave a surprising amount to comment on in our 3 blog posts from the meeting: JPM Day 1, JPM Day 2, JPM Day 3.

In this post we look at the “take homes” from the ASCO GU presentation, and what looks like it could be a new race to market.

It’s good to see novel targets for men with advanced prostate cancer, and potential new treatment options on the horizon!

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At the ASCO GU meeting in January, Dr Thomas Beer presented the initial data for the PREVAIL trial, which explored enzalutamide (Xtandi) in castrate resistant prostate cancer (CRPC) prior to chemotherapy. Reactions to the data were mixed with many analysts, perhaps naively, focusing on the significant temporal survival benefit (2 months) rather than the 29% hazard ratio, which demonstrates the magnitude in the reduction in the risk of death over the control arm.

This weekend at the American Urological Association (AUA) meeting in Orlando, Dr Christopher Evans (UC Davis), presented the updated data, including the survival curves and a subset analysis for visceral and non-visceral disease. He focused on the clinical benefits that were clinically meaningful to the urology audience.

I have to say that the data shown was both compelling and impressive to me.

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Amsterdam – Earlier today, I had the great pleasure at the European Cancer Congress to interview Oliver Sartor, MD, the Piltz Professor of Cancer Research in the medicine and urology departments of Tulane School of Medicine in New Orleans, LA.

A recognized expert in prostate cancer, Dr Sartor was gracious enough to give me an impromptu interview in the poster hall at ECCO 2013 and share his thoughts about the prostate cancer clinical data presented in Amsterdam.

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Subscribers should see a SoundCloud below that they can click on to listen to the interview with Dr Sartor. If you don’t see it, send me an email and I will provide a private URL link that will take you direct to SoundCloud.

[soundcloud url=”http://api.soundcloud.com/tracks/113217676%3Fsecret_token%3Ds-Ka2sf” params=”” width=” 100%” height=”166″ iframe=”true” /]

Takeda’s orteronel (formerly known as TAK-700) may be on its way to “dog drug heaven” after an interim analysis of the ECM-PC 5 phase 3 clinical trial showed that men with advanced prostate cancer taking the drug did not live significantly longer (HR 0.894, p=0.226) than those taking an inactive placebo.  Here’s a link to the Takeda press release.

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