Biotech Strategy Blog

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

Posts tagged ‘nivolumab’

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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What do the Konami code and targeting KRAS have in common?

It seems astonishing to realise only a couple of years ago KRAS was considered undruggable intractable and here we are, not only with one drug approved, another filed and veritable long list of fast followers, but a whole ecosystem of different agents vying for a place at the table.

The wonderful news is we are starting to think more broadly about life beyond G12C mutations, not only with different combinatorial approaches, but also also in the context of how to tackle other related mutations as well.

Here, we wanted to explore the evolving universe more broadly and assess criticality as well as applicability – which agents might shine tomorrow if clinical data turn out positive?  The simple answer is more than you know.

So just who are the rising stars in this emerging landscape and what can we learn about them?

Be warned in advance – this is one of our longest and most comprehensive reviews on BSB with over 30 compounds highlighted in different guises, so grab a cup of Joe and be prepared to come with an open mind…

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Are there challenging times ahead for KRAS inhibitor combinations?

One of the biggest challenges in any cancer combination trial is optimising the therapeutic window.  This is especially the case when there are known overlapping toxicities.  We’ve seen this happen many times in the past with targeted therapies where promising approaches from preclinical studies are subsequently abandoned in phase 1 trials because the toxicities can limit the dose that can be achieved, thereby impacting the response rates or outcomes in a negative fashion.

Immunotherapy trials also present additional challenges to be addressed in the form of immune-related adverse events, which might be potentiated or reactivated by subsequent targeted therapies, not all of which can be predicted from preclinical experiments.

Several KRAS inhibitors have already been abandoned in phase 1 development due to unexpected systemic events surfacing, as have various IO-IO or IO-targeted therapy combinations.

What happens when the KRAS and IO worlds collide?  Are there toxicities which might scupper future promising combinations and send us all back to the drawing board again?  Does the lion roar or whimper?

In our latest post, we explore the ins and outs of one such emerging controversy, including some thought leader persectives…

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The battle for early stage lung cancer continues apace

Sunrise or sunset in NSCLC?

Is it time for the dawn of a new era in early stage lung cancer or are the initial trials more of a sunset on future opportunities due to more modest than expected data?

One challenge with interim readouts in the adjuvant setting is they are a reflection of the top part of a very long survival curve, so large differences are rarely apparent at this stage when the timeline might be going out 10-12 years.  This is especially true for IO studies where these agents have consistently shown to impact landmark survival and the long tail of the Kaplan-Meier curves.

While previous studies more than a decade ago have shown some benefit for chemotherapy over observation in terms of overall survival, we have no other reference points in lung cancer, unlike breast and colon trials where some targeted therapies have seen success in the adjuvant setting.

This is very much a case then of ‘once more unto the breach, dear friends,’ as Shakespeare would say.

We have already seen approvals for immunotherapies in both neoadjuvant (nivolumab) and adjuvant (durvalumab and atezolizumab) stages of lung cancer, now it’s time to put pembrolizumab in the spotlight…

Are they building a cathedral or a brick wall?

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Important changes to watch out for in the GI cancer landscape

It’s that time of year when the ASCO GI and GU Symposiums come around, with GI up on deck first.

End of a rocky road for some GI cancers

Finally, after what seems like positive trials being few and far between we have a veritable raft of them to highlight, mostly for good reasons instead of bemoaning yet another negative phase 3 study – exciting times!

There’s also some up and coming agents in earlier development to watch out for, as well as the potential for additional indications for established drugs already approved by Health Authorities – what’s not to like?

In our latest conference Preview, we highlight some important trials and discuss them in the context of what’s gone before them to evaluate whether they will make an impact – or not…

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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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Standing out from the crowd in lung cancer

What’s standing out from the crowd in lung cancer?

It seems hard to imagine only a few years ago lung cancer was still in the doldrums with various chemotherapy doublet and triplet regimens showing little or no benefit for people with small cell (SCLC) or non-small cell (NSCLC) lung cancer.

Fast forward and my, how things have changed today with a raft of targeted and immunotherapies making a real difference to many people’s lives!

In our latest discussion highligting important trial readouts and published data, we also offer some potential new developments which might be useful down the road…

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