Biotech Strategy Blog

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

Posts tagged ‘nivolumab’

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?

BSB subscribers can read up on our latest discussion and analysis from the ESMO conference – you can log-in or click to access our latest analysis.

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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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A contrarian view of key cancer trial results

One thing I really miss from attending live conferences – aside from catching up with people in person – is “the living like a local” experience. Last time I was in Madrid, for example, there was this fishmonger (pescaderia) just a block down from the rented apartment. They were only open in the mornings, so you could dash down the hill, quickly nab some fresh produce, refrigerate it and have something nice to look forward to for dinner with a glass of wine at the end of a tiring day while writing up the highlights…

The image also offers another analogy – do some data presented at a meeting end up, well, a bit fishy on closer examination or reflection despite much of the hype enthused or extolled by others?

At the ESMO20 virtual Congress, we covered a tremendous amount of details from the data during both the daily highlights as well as the previews exploring what to watch out in the run-up to the event.  You can find all those reviews here.

There are always some surprises in store, however, both good and bad.  There’s also layers of obfuscation going on to consider in the form of cheerleading from companies, investigators, or stock holders, which may add positive spin on what is essentially so-so data, cases where great data goes largely ignored for whatever reason, or important lessons to be learned from failure.

In this wrap-up post, we take a sharp look at the ESMO20 winners, losers, and risers from a contrarian’s perspective…

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Highlights of Super Saturday at ESMO20

Not in Madrid: Unlike the Tour de France, which finishes with the peloton procession in Paris today, we’re not yet at the ESMO20 finish line and there’s plenty of the data at Congress yet to come.

Macarons anyone?

As you can see, we’re hoping ESMO21 will actually take place in Paris next year, but it’s definitely too early to make travel plans the way COVID-19 infection rates are increasing in Europe.

If we think of cancer drugs as like macarons that come in many versions – which ones do you like at #ESMO20 so far? There are are also subtle gradations in colour and flavour, reflective of a few trial differences to consider.

In this latest post we’re continuing our coverage of highlights from Saturday at ESMO20 with the second part of our commentary and analysis around some of the oral presentations involving numerous solid tumours, excluding breast cancer (see separate highlights of the day post), which caught our attention.

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Important findings on the renal cell cancer front

Looping across different types of analyses can yield intriguing and unexpected results

Not in Chicago – It still feels surreal not to have been to windy city and back for the annual meeting at ASCO this year, such was the ongoing effect of the pandemic in the oncology world.

That said, the virtual meeting has produced some gems this year, including some very important findings many may have missed.

In our latest post meeting report we focus on both biomarkers and clinical findings.

We look at how there are various elements may interplay in unexpected ways, whether signatures from one trial are helpful in another, are there likely to be changes in treatment patterns as a result of data presented and where some emerging early signals might be useful.

One other aspect which crossed my mind was how a deep scientific approach used in one particular cancer might have potential applications in other tumour types with few somatic mutations present such as TNBC, prostate cancer or soft tissue sarcomas.

The results might produce quite different results, yet the process itself might be rather useful to consider…

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The Best Clinical Data at SITC wasn’t NextCure’s NC318 Siglec–15

In honour of Armistice / Veteran’s Day 11/11

National Harbor – We’re continuing our SITC 2019 coverage with a look at some intriguing and likely controversial data.

The Best Clinical Data at SITC wasn’t NextCure’s NC318 Siglec–15 (more on that tomorrrow)

But…

Nektar’s pegylated IL–2, bempeg, in combination with nivolumab in frontline metastatic melanoma.

The controversy will no doubt continue to rage with fervent fans and equally intense deniers, but what can we learn from the latest data that was presented by Dr Adi Diab and where are things likely headed?

Included in this latest update are an in-depth thought provoking expert interview with Nektar’s Dr Jonathan ‘JZ’ Zalevsky, plus commentary and analysis on what this all means when we look at the bigger strategic picture.

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