Biotech Strategy Blog

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

Posts tagged ‘pembrolizumab’

Lessons learned from AACR24 – Part 1

Sunny San Diego is full of surprises

The AACR annual meeting is an opportunity to challenge established paradigms and scientific dogma.

In this post, we’re highlighting some key learnings we’ve taken from the conference in San Diego, which others in oncology new product development might well want to think about.

Agree or disagree, part of what we do at BSB is challenge your thinking, and consider what we can learn, both good and bad, from researchers, industry executives, thought leaders, and regulatory agencies.

There’s certainly been a lot of inspiring science on show at AACR24 and we’ll have more of those learnings to share in part 2.

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Molecular Jiu-Jitsu – Turning Cancer’s Mistakes Against Itself

What’s emerging next from the AACR box?

Synthetic lethality has always seemed a great idea on paper, yet the very nature of tumour complexity has frequently hampered our efforts to make the most of the scientific premise.

There’s a new kid on the block now with an altogether much clearer proposition on offer.

There are also several of these compounds already in the clinic with a raft of others pursuing them in preclinical development.

What’s not to like?

In our second major update on this class of agents, today’s story takes a look at where we are, what’s coming up, and where we’re headed in the context of what needs to be accomplished…

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You can’t put the genie back in the bottle

Are dark clouds rolling in on TIGIT?

Often times we see a press release for a negative trial – defined here as one which missed its primary endpoint – where the overwhelming temptation is to simply announce the top level findings and be done with it.

I will argue there are valuable lessons to be learned in the process, and sometimes, perhaps realise a different trial design or selection criteria might have led to an entirely different result.

Here is one example I’d like to highlight because phase 3 trials are already underway and there may be insights we can learn from and handicap future larger trial readouts…

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Setting the scene

Can TIGIT stand out from the crowd in gastric cancer?

We have seen all sorts of molecules come along in gastric-esophageal carcinomas, from antibodies, ADCs, bispecifics, small molecules, even CAR-T cell therapies.  Some have been more successful than others.

As the competition heats up even in the expanding number of subniches, it’s going to take some stellar data to stand out from the crowd.

We’ve already seen several miss such as Beigene’s much touted Fc-competent anti-TIGIT antibody ociperlimab in the second line setting at ESMO23 last month, while pembrolizumab continued its onward march at the ESMO Plenary back in February.

Now we have three more earlier stage agents to look at across different modalities such as Akeso’s PD1xCTLA4 bispecific cadonilimab, Keymed/AstraZeneca’s Claudin 18.2 ADC CMG901 and Arcus/Gilead’s anti-TIGIT antibody, domvanalimab.

In our latest review, we take a look at how these agents are doing…

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Who’s waving the flag at ESMO 2023?

Plaza de Cibeles, Madrid

Our coverage of the annual meeting of the European Society of Medical Oncology (ESMO) continues with a discussion on how we might go about overcoming the development of resistance or immune escape.

In order to accomplish this herculean task we perhaps need to get better at selecting the optimal combination partners in different tumour types, rather than simply taking whatever pipeline agents are available in-house and throwing them together.

The good news is there were some elegant and unexpected successes reported over the last two days, although they were offset by a few trial oddities producing negative results.

In our latest coverage, we look at examples in each category to explore what lessons can be learned from the body of evidence presented so far…

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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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An alternative perspective on Hodgkins lymphoma

Old town in Lugano

Oftentimes I find lymphoma clinical data presented as an encore at iCML are much more conducive to thoughtful reflection than than during the intense hurly burly of ASCO.

After all, not all phase 3 trials with a significant progression-free survival (PFS) will necessarily be subsequently adopted as the standard of care in the near-term without demonstration an overall benefit.

Lymphoma experts tend to be mindful of the risks of secondary malignancies, as well as long term side effects given the younger population they may be treating in some conditions.

In this review we take a look at some key data and explore the impact from several different perspectives…

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Divvying it up at ASCO23

There’s more than one way to look at data despite the same top line results

Beyond the obvious, what else was coming out at ASCO this year?

It’s time to divvy up the spoils and explore some intriguing trial results not in the mainstream consciousness.

Well there is one major trial we critique in this latest review, although perhaps with a rather different take on the data as it could be considered in a more controversial light when you look at the details.

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Caveat emptor

ESMO IO always seems a good place for finding tricky immunotherapy datasets and this year was no different with Mirati revealing their update adagrasib plus pembrolizumab data from the KRYSTAL 1 and 7 trials.

The KRAS G12C niche is not only becoming increasingly competitive, but also more controversial as time goes by.

The recently updated sotorasib data in 2L NSCLC caused some consternation and it seems the same is true for adagrasib, although in a quite different fashion.

Here we analyse the data and the clinical direction to critically assess the near to medium term opportunities, with some red and green flags to consider along the way…

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The duality and the dark side of biomarkers

Fall in Boston

Far too many cancer drugs end up being pursued for the wrong reasons in the wrong setting, which is a dreadful waste of time, money, and resources. The focus lately on speed has not helped matters either and yet companies often forget the first-in-class to market agent doesn’t guarantee best-in-class performance.

With the upcoming ENA and SITC meetings there will likely be a veritable smorgasbord of different immunotherapies being presented, not to mention a variety of new combinations or regimens to consider – how should we proceed in terms of thinking about the data coming out and which framework should we use to assess them?

In this post we offer some tips and perspective on how we should perhaps be thinking about outcome measures, and in particular the use of biomarkers, when it comes to interpreting the results from early phase clinical trials that will be presented at these meetings.

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