Biotech Strategy Blog

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

Posts tagged ‘pembrolizumab’

Is more better or is less more?

It’s time to take five lung cancer trials, put them through their paces and explain why all may not be quite what it seems in terms of future success.

Paris street cafe

The long term impact is likely to be far greater than slapping tariffs on penguins.

In the rush to declare “impressive results” or “a game changer” some observers may well be missing the bigger picture…

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New Developments in GU Cancers

GU cancers steering ahead to new ground vs. weighed down with the past

For the longest time advanced urothelial and bladder carcinomas in particular had few options available to GU oncologists once standard chemotherapy had failed to keep the disease in check.

These days, the field is going through a renaissance with a myriad of targets and therapeutic agents being evaluated as single agents and also in combination strategies.

It’s a whole new world out there, and an exciting one too.

Here we explore some of these new developments and discuss the findings in the context of the broader landscape to uncover fresh insights…

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Too Fragile to Succeed? Uncovering Hidden Weaknesses

When the crowd cheers the loudest, it’s often time to question the play.

Amid a wave of bullish investor enthusiasm for the Summit and BioNTech PD(L)1x VEGF bispecifics plus a raft of topo-I ADCs from China, the risks underpinning this rallying cry have been pushed to the shadows.

What if the foundations of the optimism are built on assumptions that don’t necessarily hold up to scrutiny?

In this analysis from the San Antonio Breast Cancer Symposium (SABCS), we unpack some of the overlooked vulnerabilities and present a case that might not win popularity contests, but could save companies and investors from costly missteps…

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What can aviation teach us about ADCs and bispecific antibodies?

Blue Angels at Pensacola NAS

The aviation industry is a great example of innovation in practice, both in terms of incremental progress and truly revolutionary breakthroughs over the last few decades.

Think how far we have come since the first flight of an engine-powered heavier-than-air aircraft by the Wright Brothers at Kitty Hawk in December 1903.

Like the pharma industry, aviation is highly regulated and during the design of a new aircraft tradeoffs must be made in terms of the features and benefits, as well as weight, range, and performance.

So what can we learn from the aviation industry when it comes to oncology product development?

Quite a lot actually! I recently spent a morning at the National Naval Aviation museum in Pensacola, Florida and was inspired by what I learned to pen this post.

As an aside – if you are ever in the area, the museum is world class and definitely well worth a visit!

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ESMO24 Preview 7 – Lighting Up Early Stage Research

While many observers following ESMO and WCLC next month will be keen on watching the phase 3 trial readouts, there’s plenty of insights to be gleaned from other research too.

For example, if we want to maintain market share of existing therapies on the market then we may need to devise solid strategies for handling combinations in the face of new competitors.

Ideally, these should be rational based on information around acquired resistance or immune escape.

Increasingly research on biomarkers as well as genomic and even transcriptomic data is becoming more commonplace.

Here we shine a light on a number of key studies, which may help us move forward with future clinical trials…

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Riding the next IO wave or a damp squib at ESMO24?

Old Post Office in Barcelona

We’ve reached the point in the oncology R&D conference season where it’s hard to predict the outcomes of quite a few trial readouts.

Some folks might well reckon a correction is needed while others are focused one future.

Either way, we put a baker’s doxer of studies under the microscope to see which ones are destined for good data while others crash and burn.

Which agents fall into into which category?

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A Renaissance in Biomarkers at ASCO24

Duomo, Firenze – a Renaissance masterpiece

This week I have been very much struck by the stark contrast between the neat, organised, and predictable nature of Renaissance architecture and the chaotic, complex, and interconnected challenge of developing robust cancer biomarkers.

While Renaissance architects could rely on established mathematical principles to create harmonious designs, scientists working on cancer biomarkers must navigate a much more unpredictable and intricate landscape, seeking patterns and reliable indicators in the midst of biological complexity.

While biomarkers are much harder to find amidst the chaos of tumour heterogeneity, this doesn’t mean the task is impossible or we should stop the attempt altogether.

In fact, it’s quite the opposite, as these intriguing examples we’ve selected for discussion from the ASCO abstracts this year illustrate…

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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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