Biotech Strategy Blog

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

Posts tagged ‘mCRPC’

The dirty little secret biotechs don’t tell you

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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Exploring novel targets and modalities in advanced cancer

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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How bispecific antibodies are reshaping cancer treatment

Rolling into Madrid!

One of the challenges we are starting to see more attention on is what happens in later lines of treatment for advanced solid tumours, regardless of whether prior therapy involved chemotherapy, immunotherapy, or hormonal therapies.

How can we provide new options for treatment of refractory disease and help more people live longer?

Finding active drugs with both a reasonable safety profile and demonstrable solid activity in a situation with more complexity in terms of the underlying biology coupled with a much higher tumour burden has long been a challenge for many oncologists and companies.

In previous years we saw how poorly checkpoint inhibitors did in this setting compared to using them upfront and while chemotherapy is very effective at shrinking tumours, the effects are rarely long lasting.

What’s next then?

One approach involves bispecific antibodies where the tumour cells and T cells are literally dragged into closer proximity, enabling the serial killers to do their job more effectively.  They worked rather nicely in blood cancers, so why not in solid tumours?

After nearly a decade of trying out many permutations of this approach, we are finally starting to see some light at the end of the tunnel with several different agents in diverse tumour types…

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Scaling the ESMO23 ramparts

Scaling the ramparts in Real Madrido

In our last ESMO23 Preview ahead of the live meeting starting on Friday, we highlight another eight targets to watch out for where there will be intriguing data dropping out from Madrid over the weekend.

More than just the data though, is consideration for the implications of the findings and how they can impact a particular tumour landscape.

One thing to note is just because a company highlights what they consider to be positive data doesn’t always mean it is actually so when you look carefully at the small print.

Not surprisingly there are a few examples of this genre at the forthcoming conference…

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Changing of the guard

A frequent challenge in oncology R&D is the fast paced nature of pipeline development such that there’s always something cool or new coming along nipping at the heels of those further ahead in clinical development coupled with the changing of the broader landscape before you even get to market.

What this means is companies with agents in phase 2 development can frequently feel rather squeezed between the two extremes.

This can lead to a lot of pondering on whether they will have enough innovation to make an impact on whatever are the favoured approaches by the time they might get to market, while at the same time offering sufficient protection against the novel compounds coming along behind.  Obviously no one drug is perfect and each will have their own achilles heels, to add to the mix and uncertainty.

For some time now there hasn’t been much in the form of new approaches in prostate cancer beyond the myriad of androgen receptor antagonists in various treatment niches plus the PARP inhibitors in a select population of men with BRCA mutations… what then?

A big question targeted therapies often have to address is their impressive initial response rates and PFS based on RECIST measurements don’t always translate into people living longer, as measured by overall survival.  No drug is without toxicities either, which means these need to be factored into the final clinical decision making and can make or break early uptake more than initially realised.

In our latest review we highlight some examples of where the field might be headed next (or not), based on some new preclinical and clinical data presented…

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To degrade or inhibit, that’s the question

Continuing our coverage of the targeted protein degradation niche, we take an in-depth look at the updated clinical data on bavdegalutamide and put the initial findings in some context.

While it’s always fun to write about the early science and preclinical data, the proof of the pudding ultimately comes from the clinical trials and whether a novel agent can impact people with cancer in positive ways such that they feel better and live longer.

In this latest example, we look at what’s happening in advanced prostate cancer, an area where we are seeing a new renaissance with a variety of therapies being tested…

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Pulling a rabbit out of a hat

It’s time to tackle some controversies in advanced prostate cancer and look at exactly who’s pulling a rabbit out of a hat?

At ASCO GU we saw new phase 3 data from the 1L metastatic castrate resistant prostate cancer (mCRPC) setting with very different results produced for olaparib and niraparib, generating quite a bit of debate.

Here we explore half a dozen key issues in the context of both trials and look under the skin at the important subtleties and nuances to think about…

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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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Advent of a new era in advanced prostate cancer treatment

ASCO21 – we may not be in Chicago, but this year’s virtual ASCO annual meeting does not disappoint in terms of a series of important clinical data emerging, which have the potential to change the cancer treatment landscape.

The results of the Novartis sponsored VISION trial with 177Lu-PSMA–617 in metastatic castration resistant prostate cancer (mCRPC) being presented in Sunday’s plenary session opens the door to a new line of treatment options which can only be of benefit to men with refractory disease.

Whether 177Lu-PSMA–617 will end up being the best radioligand therapy targeting PSMA (Prostate Specific Membrane Antigen) remains to be seen, but the company are to be congratulated in breaking new ground, with a clear path to market strategy enabling them to be the first to market in this indication.

Radioligand therapy combines a radioisotope that causes DNA damage, leading to replication stress or cell death with a tumour targeting compound. It offers a lot of potential in many cancer disease settings and is a topic we expect to hear more about as other companies follow Novartis’ lead and more knowledge is gained about optimal patient selection, dosing, sequencing and combination strategies.

Is it Mardi Gras time at ASCO?

For an expert perspective on what the VISION trial means in the context of the evolving prostate cancer landscape, BSB spoke with Dr Oliver Sartor (Tulane), who participated in the 177Lu-PSMA–617 trial.

Dr Oliver Sartor is a global prostate cancer expert who we’ve had the pleasure to talk with a few times over the years. He’s a professor at Tulane University in New Orleans and Medical Director of the Tulane Cancer Center.

He cheerfully told BSB:

“This is an exciting development with the VISION trial and I think it changes the landscape, even though it is sort of at the end of therapy – these patients were pretty heavily pre-treated.

I think it has implications as we look over the overall landscape for a whole variety of patients, and of course, this therapy is likely to move earlier and trials are already designed to help it move earlier. So I’m excited about the progress for a PSMA targeted therapy with Lutetium–177 and I think it is going to have implications for years to come.”

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On finding new targets and boosting existing therapies

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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