Biotech Strategy Blog

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

Posts tagged ‘nivolumab’

Shining a beacon

Shining a beacon on key GI trials

After covering a lot of science of late it’s now time to review some recent clinical data, discuss some of the implications of the findings, and their potential impact.

After all, science doesn’t exist in a vacuum and how it translates into outcomes in people living with cancer is an important part of the process.

Can we help them live longer and feel better are two important questions to ask when looking at study readouts.

Let’s not forget there’s quite a difference when considering the exposure of light from a lighthouse beacon versus a typical torch.

The former is designed to produce an extremely powerful, far-reaching beam that can propagate over long distances. A torch has much more modest lighting capabilities suitable for short-range use. The exact brightness difference depends on the specific lighthouse and torch, but it can reasonably be assumed the lighthouse beam is orders of magnitude more intense.

In a similar fashion, we need to look at phase 1 and 3 trials through different lenses, just as we ought to do with the potential 14th agent to market versus the first…

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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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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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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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Reflections on ESMO22

Vive La France! 

Despite the raft of negative trials presented in Paris this year, it wasn’t all bad news, although for a while it certainly seemed this way with quite a few phase 3 trials missing their primary endpoints.

It’s time for our ESMO review where we highlight no less than 10 trials offering positive vibes and encouraging signals, particularly in early stage development.

So what were the standouts and why do they matter?

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Sorting out confusion, confliction, and confounding results in clear cell RCC

Which direction should we go in early stage RCC?

The battle for early stage RCC at the European Society of Medical Oncology (ESMO) is turning out to be quite a humdinger this year with quite a few unexpected surprises in store given the variety of trials with different agents and combinations generating a disparate variety of readouts.

Why is this and what can we do/learn from the findings?

In this post, we offer an in-depth discussion and commentary from various GU and IO experts…

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New controversies in GI malignancies

Gastronomic delicacies in Paris

In our second ESMO 2022 Preview we take a look at some of the key trials being presented in gastrointestinal cancers and highlight what to watch out for on this front.

While a few readers will no doubt be keen to skip to the KRAS section to learn more about sotorasib and adagrasib in colorectal cancer, make no mistake there’s plenty going on in new product development in several other GI cancers too, both with targeted therapies as well as immunotherapies.

Curious to learn more?

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ESMO22 Preview 1 – what to watch out for in breast cancer

Time to make your selections!

This year seems to be going all to quickly as we have arrived in time for the annual ESMO Preview series.

This year we have a lot of topics to cover from a review of various solid tumour types, novel targets and developmental therapeutics, hematologic malignancies, as well as various IO and cell therapy related readouts.

As always, the goal of our previews is to not only provide some context for what to expect, but also to highlight potential success and failures since not all of the trials have been headlined by the companies concerned.

It’s all to easy to forget agents in the same class of therapeutics can produce quite different outcomes despite similarly looking trial designs, as we will find out…

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New directions in small cell lung cancer

Linie 30 Florisdorf, Vienna

With all the frequent attention on lung cancer of late – mostly on the most common form, non-small cell lung cancer – it’s easy to forget small cell lung cancer (SCLC) in the rush to highlight new developments.

It’s time to talk turkey about old and new agents in the quest to improve outcomes for people with this dismal disease.

The good news is there are also a raft of scientific developments emerging, which may potentially help us better identify discrete subsets and enable the matching of appropriate regimens to the underlying biology.

At the World Conference in Lung Cancer this week in Vienna we’ve been following the numerous trials (and tribulations!) of progress in this niche, with a look at several key readouts through the lens of a thoracic lung cancer specialist.

What does he have to say and where are things heading next for the field?

To find out more, check out the interview below…

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