Biotech Strategy Blog

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

Posts tagged ‘T-DXd’

Upping the Game

The conversation at this year’s ASCO sessions in some of the less sought after cancers carried an undercurrent of cautious optimism rarely heard in these halls.

Time for some new pathways and fresh directions

After decades of incremental progress and sobering statistics, investigators are grappling with an unexpected problem: how to sequence, combine, and optimise a sudden influx of active agents targeting pathways, which actually seem to matter.

The familiar old refrain of “nothing works in X!” is giving way to more complex questions about biomarker selection and maintenance strategies.

It’s entirely possible we’re finally approaching the critical mass of effective therapies needed to fundamentally alter the disease trajectories.

Yet beneath this enthusiasm lies a nagging awareness of how the most challenging aspects of these cancers remain untouched by our expanding arsenal.

In this review, we explore a number of different agents showing early promise, which may offer opportunities for intrepid companies seeking to make a real difference…

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Gunfight at the ASCO Corral

In the fast-moving world of metastatic breast cancer, therapeutic relevance can shift in the time it takes for a single conference session to end.

At the annual meeting for the American Society of Clinical Oncology (ASCO) this year, the spotlight has turned to ESR1 mutations, once a niche biomarker, now a battleground for drug developers navigating a crowded and volatile landscape.

Between fresh data, biomarker insights, and shifting treatment paradigms, one thing is clear: the rules of engagement are changing, and not everyone will make it out of this showdown intact.

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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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Sorting out the clunkers in a crowded field

Early last year I started tracking and coding the various elements as new ADC agents began emerging post JPM23 from various conference presentations and BD&L activity. I quickly ran out of colours!

A couple of trends quickly became apparent.

Big Pharma – needing to replenish pipelines – were gleefully snapping up topoisomerase-based ADCs and Asian countries who had a seemingly bottomless pit to supply their pent-up demand were the main beneficiaries.

Bergen harbour – where elegant ships and rusted clunkers rub should to shoulder

There are a number of reasons why this may not be the best idea in terms of R&D, however.

Some of them may do well, while many will turn out to be clunkers and likely fail.

This latest gold rush is not going to end well for some players and there will be many tears before bed time once everything shake out.

Today’s story adds some more evidence to the mix for consideration…

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ADCs – Controversies, Challenges, and Opportunities

The romantics wearing rose tinted glasses might well think of successful cancer drug development much like the famous poem by Lord Byron;

“She walks in beauty, like the night
Of cloudless climes and starry skies”

Yet the reality is much more opaque with endless cloudy or wet days and foggy nights much more typical than the exception.

There are often unexpected glitches in the form of serious adverse events, drug interactions, biomarker crashes, narrower therapeutic indexes and poor activity.

None of this stops a raft of companies rushing into a niche when it is suddenly declared ‘hot’ and everyone wants a piece of the action.  This creates an entirely different series of issues to tackle such as acquired resistance and cross resistance.

Some of the numbers in this latest research surprised me and left me pondering a series of provocative questions such as who’s going to stand out from the crowd, who is going finesse things in the clinic – and most importantly – who’s going to break the mould with a different approach?

In this article we explain some of the nuances at play and offer some pointers of new directions the field is taking, not all of them, I’m sorry to say, are for the better…

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ESMO Preview 2 – Making sense of controversy

Plaza de Cibeles, Madrid

In our latest ESMO preview series, we selected a modality to focus on and explore the potential opportunities and challenges many will face in the clinic.

There are a number of issues to address in this space:

  • Will new developments in technical design features help us see more agents over the finish line or are they doomed to repeat the mistakes of past?
  • As we see a much broader range of targets being evaluated, will this help or hinder the process?
  • What factors need to see improvement if we want to increase the number of Health Authority approvals?

There is no doubt the face of oncology R&D is changing – will recent successes help others over the line as well?  To find out, we looked a large number of abstracts and selected some for discussion.

Here are our insights on the current state of play…

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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 good, the bad, the plain old ugly, and the promising

There’s no ASCO meeting without the Bean

There’s always a parable or two to be had at ASCO and this year was no different, especially in the breast cancer space where there were plenty of phase 2 and 3 trials to discuss as well as offer commentary on the various findings.

Not all of the results were standouts though, with some creating controversy in the process.

Here, we take a look at some examples and put them in context…

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Five key areas to watch out for at ASCO22

Star of the show?

In our latest ASCO Preview this year we highlight five key areas to watch out for, why they have been selected for attention, and also offer some broader competitive context.

In short, it’s time to talk about some of the key abstracts I’m excited about at ASCO this year.

Please note this particular selection excludes immunotherapy and cell therapy products since they will be covered separately…

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