Biotech Strategy Blog

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

Posts from the ‘Head & Neck’ category

Iron Men of CrosbyThis is the third in our mini-series previewing the forthcoming European Society for Medical Oncology 2016 Congress in Copenhagen (Twitter #ESMO16).

In this post we’re taking a look at what’s hot in head and neck cancer.

It’s not a cancer type we typically hear a lot about, but there’s an unmet medical need for effective new treatments.

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It’s been very clear for over four years now that combinations were going to be necessary if we want to a larger number of deeper and more durable responses than can attained with monotherapy.  Gradually, we are starting to see early and very preliminary readouts with some of the trials in progress.

We are also learning very quickly that it’s going to be a case of #notalltumours and #notallsubsets.

ASCO 2016 Posters 2

Another very busy poster session at #ASCO16!

By this, I mean we obviously can’t take a one-combination-fits-all approach for all tumour types.

We need to be able to classify patients into more homogenous subsets and then devise different combinations or even sequences that address the underlying biology of both the cancer itself and also the tumour microenvironment.  That’s going to take a while to sort out, perhaps even years.

Let’s not forget though that in the meantime, we can gather information quite a few clues both preclinically, as well as from initial clinical studies.  Sometimes, after all, we even learn more from negative trials than positive ones. This is an area that is ripe for combinations with traditional targeted therapies, the question is which ones are promising and why?

We took a look at the landscape in SCCH&N and how this might evolve over time in the medium term, with future opportunities, that can be explored in rational combination approaches.

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One of the obvious learnings from the American Association of Clinical Research (AACR) meeting earlier this week was that we are coming to the end of the low hanging fruit opportunities for checkpoint inhibitors as monotherapies.

Speaking with numerous company people in this space, there was wide consensus on that point. As one clinical lead put it succinctly, “From here on out, it’s going to get way more complicated – had a low grade headache develop after the very first science session I attended – and it’s still there after two days!”

How many of us know that feeling all too well?  AACR always has the heaviest science load of any cancer conference we attend each year. Sure there’s some nice clinical data, but that is like nibbling on the light appetizers before the 20 course banquet. You need much stamina and fortitude to survive the brain fog at AACR. Then there’s the glee at snagging some key poster handouts at the meeting, only to be rapidly diminished when you try to read the 4pt print post hoc and realise your eyes cannot focus easily.

Looking at the long list of topics I want to cover in the in-depth post meeting analysis for a ‘lighter’ post, especially given that it’s Friday after a very long week, that sinking feeling hit home hard – there are no lightweight topics at AACR.

The other day, we posted about the promising data in triple negative breast cancer (TNBC), following on from the Genentech and Merck presentations at the San Antonio Breast Cancer Symposium (SABCS). These data surprised many folks, mostly because they didn’t consider breast cancer to be an immunogenic tumour – nor is lung cancer in the broader scheme of things for that matter – yet we are seeing some nice durable responses in both tumour types with checkpoint inhibitors.

In other words, our definition and perceptions must change as we redefine how we identify and think of possible ‘responsive’ cancers to these agents.

So where are likely heading next?

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Quick Reminder: Today is the last day for the AACR Special – the discount ends at midnight ET tonight. We may not offer this rate again as it’s a limited time only deal!

Immuno-oncology is one of the hottest topics, if not, the hottest in cancer drug development at the moment, and every conference seems to advance the field forward. The pace of progress is breathtaking as thought leaders and pharma & biotech seek to maximize how to leverage the body’s immune system in the fight against cancer. It’s exciting times!

Coming up next on the calendar are two cancer conferences, the Society for Immunotherapy of Cancer (SITC) held in Maryland later this week, followed swiftly by the EORTC-AACR-NCI Molecular Targets conference (often referred to as the Triple meeting by industry insiders) in Barcelona just before Thanksgiving.

SITC 2014 Immunotherapy Banner

Whoa, that’s a lot of data yet to come, and then in December we have the American Society of Hematology (ASH) and San Antonio Breast Cancer Symposium (SABCS).

Back home in the Blighty, November is often referred to as the ‘month of the drowned dog’ because it rains a lot… at this rate it’s more like raining data – let’s hope not too many agents are headed for dog drug heaven! The good news for subscribers is there’s a lot of conference coverage to come!

2014 ESMO Congress Poster HallSo here we are, after nearly two dozen posts, it’s time to close out the 2014 ESMO coverage with a final review of the immuno-oncology posters that piqued our interest.

There were 16 in all that fitted that category. Normally, we highlight three or four gems from the poster halls, so more than a baker’s dozen is quite a feast.

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Yesterday, the European Society of Medical Oncology (ESMO) released the abstracts to the poster and poster discussion sessions.  This preview will be quite long by nature of it being the first time we get a look at the topline details behind some of the key sessions and their abstracts for both immunotherapies (especially checkpoint inhibitors) and targeted therapies.  This includes posters and their discussion sessions, plus poster late breaking poster titles.

For reference, you can find the ESMO 2014 poster and poster discussion abstracts can be found here.

In addition, there appears to be some pretty cool presentations in the Special Symposia, which are rather like ASCO scientific symposia and contain a lot of useful information and often strategic ideas about where thought leaders see hot topics going in the future.  This can be very helpful in learning about possibilities for new clinical trials ahead of time. As we focus on the poster highlights today, do check back tomorrow for a detailed look at the scientific symposia.

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Our ASCO 2014 conference coverage continues with more gems from the poster sessions; it’s where we believe you find the promising gems that offer hints of future promise (or not) as the case maybe.

ASCO 2014 General Poster HallSometimes a failure with one agent can help another company design a more optimal trial for their own new product in development, thus moving the field on. Other times, a surprising result can emerge that teaches us something new about the science and increasing our body of knowledge about pathways or biomarkers.

The other thing to understand about phase I trials is that they are generally conducted in the salvage situation where patients are refractory to most current treatments.  The disease burden is high and the patients much sicker than when they were newly diagnosed. What companies are looking for is to characterise the side effect and PK profiles while looking for possible hints of where the agent might be efficacious.  Given that most cancer therapies are given in combination, it’s very rare to see a home run in phase I, especially in solid tumours.

Here are a triplet of interesting posters from small companies looking at moving the needle in solid tumours with early phase I studies:

Companies mentioned: Nucana, OncoMed, Celldex

Agents mentioned: Acelarin, OMP–59R5, varlilumab

Over the last few days, we’ve covered data from the leading checkpoint inhibitors from BMS, Merck and Roche, but what about other agents in development in immuno-oncology? One of the companies that burst on the scene in Chicago at ASCO 2014 with solid data was AstraZeneca with their anti-PD-L1, MEDI4736.

To put progress in context, last year Merck had one single abstract for MK–3475 (pembrolizumab), whereas this year MEDI4736 debuted with 7 abstracts, including several Trials in Progress posters in combination with their anti-CTLA4, tremelimumab, plus some important oral presentations too.

The last morning of the final day of the ASCO conference has not exactly been well attended in past years, especially in Developmental Therapeutics. This year was different – the large hall was jam packed and it was standing room only. I was lucky to get one of the last seats in the front row a good 15–20 mins early!

As we were waiting for the proceedings to start, the Japanese doctor sitting next to me turned and said:

“What do you think of this compound? I’m not expecting much, and they are behind the others already!”

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