Biotech Strategy Blog

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

Posts tagged ‘abiraterone’

The Fall and Rise of Essa Pharma

Today’s post highlights the lessons learned as part of the trial and tribulations associated with oncology R&D, including a large dash from vibe of the famous British sitcom, “The Fall and Rise of Reginald Perrin.”

Madrid city centre at dusk

No matter what industry outsiders think, drug development very rarely goes in a straight line from A-Z since there are often many expected – and even unexpected – twists along the way.

The company we’re focusing on is Essa Pharma, and boy, do they have some challenges and unexpected plot twists as part of their corporate DNA!

I often hear from artistic friends paraphrasing Ursula Le Guin that it’s all about the journey, not the destination.

Except in business and especially in Pharmaland, however, it is entirely about the destination and how you get there doesn’t matter so much. After all, if a small biotech doesn’t get a product in development over the finish line (aka approval) and become a commercial success then it’s game over for everyone involved.

This is one of those kind of stories.

A tale of belief, tension, tenacity, re-tooling, and finally, renewed hope…

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Fishing for Gems from the Poster Halls Part 1

Fishing for oncology new product gems

One of my favourite exercises at conferences is exploring new or emerging targets in the the poster halls, either in the context of preclinical or early phase 1 data.

Undoubtedly it often ends up as a bit of a fishing expedition – you have all the anticipation and excitement upfront and just as in real life, sometimes you go home empty when nothing bites as happened to a couple of guys I was watching fishing in the bayou last weekend!

Much to their frustration, the mullet gleefully jumped around them without going near.

Assessing early stage oncology pipeline development is a bit like this too.  After following this particular niche for a while, it was time to take stock with a new clinical readout available.

Did the data live up to expectations or not?

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Olaparib drives earlier and deeper responses in mCRPC

With two oncology data drops running this week in the ASCO Plenary session plus the GU sympoisum, it’s time to switch our attention from cell therapy novelties to new developments in targeted therapies.

In this discussion, we take a look at an important phase 3 trial readout being presented this week in metastatic castration resistant prostate cancer (mCRPC).

For far too long the GU oncologist’s choices were pretty much limited to androgen receptor (AR) antagonists such as enzalutamide and abiraterone and chemotherapy (docetaxel and cabazitaxel).

Then along came PARP inhibitors such as olaparib, rucaparib, and more recently niraparib, largely limited to men with homologous recombination repair deficiencies who had received prior therapy, with the first two receiving full or accelerated approval in first half of 2020 on the basis of the PROfound and TRITON2 studies, respectively.

The third PARPi is further behind the others, finally just publishing their phase 2 monotherapy data from GALAHAD earlier this month.

Now there’s a new phase 3 data readout to explore and consider in the context of earlier in the disease setting…

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When things fall apart

One of the things that struck me at this year’s ESMO conference was the sheer variety and richness of the data across multiple treatment modalities, tumour types and even new products coming through the pipeline to vie with established products for time and attention.

It’s also interesting to see what kind of questions readers have – it’s time for another mailbag session where we take reader questions and attempt to put some colour and context on the answers, as well as offer some predictions in some cases.

The current crop spanned a wide range of topics and issues from TKIs and DDR agents to immunotherapy, and not just checkpoint blockade either!  People specifically wanted to know about various targets and different modalities, including cell therapies.

So what’s on offer in the candy store today and were they substantial in nature or should we dismiss them as weak sugar pills?

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Crossing the Rubicon

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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Future directions in advanced prostate cancer

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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What’s Hot in Ovarian Cancer at ESMO16?

westminster-embankmentToday’s news that an FDA Oncologic Drugs Advisory Committee (ODAC) review will not be required for rucaparib is good news for Clovis Oncology. The company announced this via an SEC 8K filing:

“The Food and Drug Administration (“FDA”) has notified Clovis Oncology, Inc. that FDA is not currently planning to hold an advisory committee meeting to discuss the Company’s New Drug Application for rucaparib.”

However, given the unmet medical need in ovarian cancer, a lot of companies are targeting both platinum sensitive and platinum resistant disease.

In our fourth preview of the forthcoming European Society for Medical Oncology (#ESMO16) meeting we’re looking at 9 key ovarian cancer abstracts to watch out for at ESMO.

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EAU 2015 Update on enzalutamide PREVAIL trial in advanced prostate cancer

PREVAIL trial EAU 2015We’ve been following the updates on the PREVAIL study evaluating enzalutamide (Xtandi) versus placebo in metastatic castrate-resistant prostate cancer (CRPC) in the pre-chemotherapy setting for a while now. It’s interesting to see how the data evolves over time as it becomes more mature.

The first presentation, back in January 2014 at ASCO GU by Dr Tom Beer (OHSU) reported on the first 540 deaths and was subsequently followed by an update of the survival data at AUA in May of the same year by Dr Chris Evans (UCLA).

This morning at the European Urology Association (EAU) in Madrid in the late breaking session on prostate cancer, the honour fell to Professor Bertrand Tombal (Leuven), who did a very nice job of reviewing the mature PREVAIL data (based on 765 deaths) and providing some context for how the CRPC landscape is being impacted by AR pathway inhibitors.

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Is AR-V7 a useful predictive biomarker in advanced prostate cancer

After the intensity of gastrointestinal cancer, we now turn our attention to genitourinary (GU) cancers with the upcoming ASCO GU meeting later this week in Orlando.

Two of the big topics here will be prostate and renal cell (RCC) cancers.

Unfortunately, the long awaited data in adjuvant RCC demonstrated that early treatment with sorafenib or sunitinib did not improve outcomes in locally advanced kidney cancer after resection. According to the ASCO press release, the trial conducted by Dr Haas and colleagues at U Penn discovered that:

“The average period to disease recurrence was similar between those who received sorafenib or sunitinib after surgery (5.6 years) and those treated with placebo (5.7 years).”

We will therefore turn our attention to castration resistant prostate cancer (CRPC).

One of the recent and ongoing controversies is splice variants, especially AR-V7, which is thought by some research groups to confer resistance to the hormonal therapies, enzalutamide and abiraterone. The big question though, is does it, and how useful is an assay in helping to determine appropriate therapy? Are there other factors at play?

We looked at the latest data and put the findings in context with what we know from other published research.

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Insights on the enzalutamide PREVAIL data pre-chemotherapy in advanced prostate cancer

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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