Biotech Strategy Blog

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

Posts tagged ‘ovarian cancer’

Not in Madrid: The 2020 virtual congress of the European Society for Medical Oncology (#ESMO20) is underway and in this post we’re taking a look at some of the highlights from Friday at ESMO20, a day when we’ve seen a raft of posters and mini-orals released for on-demand viewing.

ESMO20 BannerWith COVID-19 rates rising across Europe, ESMO are to be congratulated for pivoting to a virtual meeting that allows the sharing of knowledge and advancement of the field. It was definitely the right decision in light of the ongoing travel challenges, quarantines, not to mention restrictions on large groups in many countries.

For our daily ESMO20 coverage – just as we would if we had been in Madrid – we’ve been listening to some of the on-demand mini-oral presentations and associated discussions, with a view to picking out and commenting on a few that stood out for us.

As always we’re approaching this from a cancer new product development perspective, and our choice is always a balance of emerging new targets and drugs, as well as following those we’ve previously written about.

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Part of the next wave of early immuno-oncology agents are focused on addressing the tumour microenvironment and inhibitory factors that dampen down immune responses.

As we look at all the options available, there are a few obvious ones such as physical barriers and inhibitory cytokines or chemokines, but beyond that are a vast array of other potential targets we can aim at therapeutically.

We have covered quite a few of these already, but here’s a new one to add to the list.

One particular advantage is that because it is early in development, few competitors have cottoned on to the concept yet. First mover advantage can have quite a few benefits, after all.

Here’s an important question to consider in terms of oncology R&D – would you rather explore a blue ocean strategy or follow the lemmings off the cliff and be 14th to market in a highly competitive red ocean?

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The calm before the morning storm surge at ESMO19!

Barcelona – I can’t recall the last time we published three long form posts from a conference before high noon (US time) on the same morning, but that certainly illustrates how busy this year’s ESMO is and there’s a lot more to come yet.

The initial starting coverage for today includes hot topics in ovarian, lung, and colorectal cancers and more will be added in due course.

If you are looking for osimetinib in FLAURA and AMG 510 in KRASm colorectal cancers, click on the BSB log in the top left corner to check out the front page slider for more information on those write-ups and commentary!

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Padstow, Cornwall – It’s May Day or ‘Obby ‘Oss, as it’s known locally in this little corner of south west England.  The quaint festival means that it’s the biggest day of the year as over 30,000 people crowd into the tiny fishing village.

Obby Oss Blue

Centuries old traditions are still alive and well in this part of the country and the big question of the day (are you red and white or blue and white?) is a far cry from the complex high tech world of cancer research.

Still, with all the time and attention focused on immunotherapy and targeted therapies of late, it is all too easy to forget what’s happening on the epigenetics front, which is quite a bit in practice.

We often see random allcomer approaches to clinical trials, which are find for phase 1 studies where you want to gather data on responders and non-responders in order to conduct PK/PD and immune profiling, as well as biomarker and signature development, but a potential recipe for disaster in phase 3 if you have no idea exactly what’s driving the efficacy since you can all too easily end up with unbalanced arms that you didn’t control for and thus skew your survival curves in a way you didn’t anticipate.

Why on earth would you use a targeted therapy in an untargeted fashion? Hmmm obvious question and yet, many companies still do this all the time.

There are some biotechs out there, I’m pleased to say, who do conduct extensive translational and biomarker research.  Obviously finding those markers is a lot more tricky than choosing red or blue.

One biotech company we have been keenly following for a while is Syros.

We first wrote about them in Spring 2014 and now, five years on, I thought it would be a nice idea to catch up with one of their founders and learn more about the science underpinning what they’ve done and where they’re going with future projects. Not only do they invest in smart medicinal chemists, profiling and translational research, but they also seek to identify rational reasons why people respond to their compounds.

The answers were rather interesting and there’s quite a bit that readers might be curious to learn more about…

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File under: intriguing binary events coming up of interest this quarter…

Source: BBC

There are a couple of phase 3 readouts likely due soon on two quite different oncology drugs in late stage development, namely Mirv and Marge, (aka mirvetuximab soravtansine and margetuximab).

For British readers, they remind me of Howard and Hilda Hughes (right) in the highly popular 1980’s comedy sitcom, lead by Richard Briers, Ever Decreasing Circles.

Aside from the fact that it’s an amusing historical analogy with more than a bit of whimsy, there are some strange parallels and hidden messages to be found here. For the record, the two characters had a penchance for wearing matching yet rather garish and ghastly jumpers.

You could either make a similar negative case for the rush from limited phase 2 data to pivotal registration study as for terribly ugly sweaters, with the reduced return on efficacy being alluded to from the show’s title.

The ripple effect – which way will it go?

Or on the other hand… the matchy matchy look could also play out the other way, in terms of positive forthcoming readouts validating phase 2 findings, so which case looks stronger overall for each agent?

To find out, we take a look at the history, what we know, and share our thoughts on how things might pan out – either way, major positive or negative outcomes can have a major ripple effect.

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Dr Moore at ESMO18

At the recent European Society of Medical Oncology (ESMO18) Congress in Munich, arguably the data of the meeting – if the audience reaction is anything to go by – were the results from the phase 3 SOLO1 trial that were presented by Dr Kathleen Moore (right).

The results were simultaneously published in The New England Journal of Medicine in an article entitled: “Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer” (Link).

As Moore and colleagues note in the abstract:

“After a median follow-up of 41 months, the risk of disease progression or death was 70% lower with olaparib than with placebo (Kaplan–Meier estimate of the rate of freedom from disease progression and from death at 3 years, 60% vs. 27%; hazard ratio for disease progression or death, 0.30; 95% confidence interval, 0.23 to 0.41; P < 0.001).”

Dr Moore is an Associate Professor of gynecologic oncology and the Jim and Christy Everest Endowed Chair in Cancer Research at the University of Oklahoma Stephenson Cancer Center.  She kindly spoke to BSB after her presentation in the Presidential Symposium.

In addition to Dr Moore’s personal commentary on what these results mean for women with ovarian cancer, we also have some additional insights on what this data may mean for other players in the PARP space such as Tesaro and Clovis.

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Picking a PARPi – what can the biology tell us?

One of the really interesting questions I recently received from a BSB subscriber related to PARP inhibitors – they asked whether the therapies are all the same and can be considered interchangeable as a class?

Around the same time, another reader wrote in asking if there was any new information on what’s happening with PARPi combinations in breast or ovarian cancers?

This got me thinking as there has actually been some useful preclinical and clinical studies reported on both fronts that at least begin to open our eyes to new information based on research that has been reported in several places.

Thus I thought it would be useful to summarise the data and take a look at what we learned in the process.

Fair warning – some of the findings turned out to be a little bit more surprising than you might normally expect to see…

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We know that not every patient responds to checkpoint therapy and some may respond but then stop responding, so what can we learn about the tumour microenvironment in order to fix it?

To do this may well require retrospective analyses of the existing trials in order to learn what happened and figure out an improved design of the next wave of clinical trials with rationally based combinations (as opposed to randomly testing two molecules simply because that’s what a company has in its pipeline).

The other thing to consider is that while some people might have a high level of a particular marker or inhibitory factor up front, others may see rise on treatment as an adaptive response to immunotherapy. Those two situations may well require quite different approaches or regimens to address, making things much more complicated than originally thought.

Dr Kunle Odunsi (Roswell Park) at #AACR18

One topic that caught our attention in the run-up to AACR and subsequently during the meeting was a cytokine called transforming growth factor beta (TGF-β). We have covered IL–2, IL–6 and IL–15 developments quite extensively on BSB, but what of TGF-β?

As such, we decided to investigate this little known target further and explore the concept from different perspectives in both academia and industry.

Today, we begin this latest mini-series with a thought leader interview from an academic institution who is researching a novel approach to combination therapy based on TGF-β – here’s what he had to say about the topic…

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One of the many challenges we have seen with cancer immunotherapy and immune checkpoint blockade in particular is the thorny issue of how long should patients be treated for?

To be fair there are some studies testing a limited time period, but most are open ended in that patients are treated until progression or severe toxicities prevent continuation, whichever comes first.

Ovarian cancer TME Source: NCI

Is this the optimal approach though, especially if people receive the benefit and any more is superfluous, thereby increasing the twin burdens of clinical and financial toxicity.

Are there indicators that predict early discontinuation?

After all, if oncologists were aware of those factors then careful monitoring will be helpful in looking out for the warning signs.

Without a doubt, this is going to be a long road ahead and the path may be paved with different indicators depending on the tumour type involved. It could also become more complex as we move from monotherapy to doublets to regimens, which also increases the risk of clinical and financial toxicities.

We have to start somewhere and I’m delighted to say that I came across some elegant research that explored this issue and came up with some prediction factors of relevance. As a bonus, they actually make sound and intuitive sense too.

Here we describe the important study and look at the prediction factors that emerge…

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2018 is likely to be the year of various immunotherapy combinations as we go beyond monotherapy approaches to see which doublets or triplets will yield improved outcomes. Originally, we had expected to see key data last year, but moving overall survival to a co-primary endpoint with PFS in many studies delayed the readouts by 12 or more months.

SGO 2018 – Who dat?

What’s happening now is that we have started to see some of the early data trickle out and there’s much more to come in the next few months as we head into ASCO and ESMO.

The last two months have seen much attention on lung cancer, but what about a less hyper-mutated tumour types such as ovarian or endometrial cancers? What’s happening in these women’s cancers?

Going beyond monotherapy with PARP inhibitors or checkpoint blockade is important if we truly want to start pushing the survival curves upwards and to the right.

It’s time for a new update on this hypercompetitive niche…

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