It feels weird to be covering the WCLC from Singapore remotely after remembering the rain in Spain at WCLC19!
If we look at the more mature phase 2 data now available for Amgen’s sotorasib (AMG 510) in KRAS G12C driven lung cancers, we learn there are quite a few nuances and subtleties at play. These aren’t always obvious in top line press releases or even in presentations until we consider the broader niche in which they are competing.
Amgen submitted the sotorasib applications to both the US and EMA health authorities in December. With breakthrough designation status and clinical evidence of activity in an area of high unmet medical need, it’s hard to believe the approval won’t be forthcoming sooner rather than later, at least in the US.
Mirati is expected to showcase their phase 2 data later this year, so I would highly encourage people to hold off with cross-trial comparisons until we see how their more robust data look at the RP2D.
In the meantime, we can take a careful look at the latest Amgen data. We do those not only from a BSB review but also through the lens of a company perspective and consider some of the key strategic issues we need to start thinking about…
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The calm before the storm as the KRAS competition heats up and also gets more complex in the process
I was very tempted to tease everyone and say something along the lines of… ‘while you were all partying, there was some new KRAS clinical data being presented somewhere in the world’ but that would be rather naughty, I suspect.
Instead, I’ll simply point out that it’s time to take a look at the latest phase 1 data in the KRAS niche.
What more clinical data already?!
Yes there is and what’s more it doesn’t belong to the either of the leading two in the early race to market, aka Amgen and Mirati. There’s a whole bigger world out there for those interested in following the broader slate runners and riders. It pays to pay attention because this is not a race about single agent therapies, rather it’s about who figures out the optimal combinations and is able to finesse that better than their competitors. Like real horse races, an unexpected runner can surprise a few folks by making a strong push on the rails or a bounding leap round the outside like Lester Piggott was famous for doing.
This highly specialised field is moving much faster than the BRAFV600E arena was a decade ago and there’s also more players involved too, plus multiple different approaches and targets to consider, which I expect we will be covering quite a few times during 2020.
Are you ready?
Get set, GO!
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Fall in Boston during the AACR-NCI-EORTC Triple meeting
After recent updates on targeting KRASG12C and HRAS, let’s not forget that there are plenty of other elements of the RAS pathway that can be considered, not least is upstream receptor kinases such as EGFR and sideways to SHP2.
What happens when those worlds collide?
Quite a bit it would seem.
If we want to seriously impact patient outcomes for the better then we need to explore rational combination approaches.
Here’s one way to do it…
Please note that this is an early target with not very many competitors, so there’s plenty that can happen here on multiple fronts!
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Barcelona – Today is going to be a very long and complex day at ESMO, with a multitude of key data expected from several trials ranging from the phase 1 Amgen data update on their KRASG12C inhibitor, AMG 510, AstraZeneca’s osimertinib in the FLAURA study plus a raft of others, including the phase 3 PAOLA–1 and CheckMate–227 trials.
In order to keep all the information straight and manage the various embargo deadlines at wildly different times, we’re going to break with tradition and post three different articles at different times on KRAS, FLAURA, and the daily running log of various studies and posters that catch our interest. Yes it’s a lot more work, but it’s the only way to manage all the deadlines!
This post will focus solely for the KRAS updates at ESMO19, including the initial data release, the presentation, analyses, and commentary. No doubt that means a series of updates will ensue so do check back regularly or follow the alerts on Twitter via @biotechstrategy.
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Chariots of Fire in Barcelona?
Barcelona – Gosh, what a weekend chock full of lung cancer data at the World Congress on Lung Cancer hosted by the IASLC!
There’s nothing like a bit of controversy to get riled up or crash with disappointed hopes under the weight of expectation, but if we go under the hood and look carefully, what do we find?
There was a lot of topics that we’re going to cover the important highlights and learnings in a two parter series – today we focus on KRAS with targeted therapy, while tomorrow we look at other topics of interest, both targeted and immunologic.
Without much ado, let’s roll with the Amgen update as there are many subtleties and nuances to consider…
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Unlike last year, rain in San Francisco wasn’t a feature in 2019
If there’s anyone who hasn’t got fed up looking for somewhere to sit and chat or have a meeting in San Francisco at the 2019 JP Morgan Healthcare conference this week, then don’t be surprised…
With meeting space continually at a premium and many attendees unwilling to pay exhorbitant table rental prices, you now see people resorting to the lobby steps at the Sir Francis Drake, while the ladies have the advantage over the gents of access to the powder room in the Westin (with plugs!)
There’s also a movement from the chic to the shabby:
JPM is as much about informal meetings, pitches and confabs about new ideas, as it is about the actual CEO presentations, and so this situation is likely to continue in future years.
Meanwhile, we continue to dive in with our latest daily blog and put a bunch of companies through their paces. If day 1 is all about the big pharmas, by day 3 the focus is much more on up and coming or mid sized biotechs…
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