Biotech Strategy Blog

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

Posts from the ‘Cancer’ category

Periodically, we post an analysis and look at a particular landscape and the leading competitors within. One area of rather intense interest that we have been following is the progress (or march might be more precise) of checkpoint blockade in previously untreated metastatic non-small cell lung cancer (1L NSCLC).

Our extensive reviews and discussions in this area have included a look at:

In addition, I last posted my recent predictions on this space in July this year and already quite a bit has happened since then!

With a bunch of other phase 3 trial readouts coming up over the next couple of months, it’s now time for another update on what to watch out for, what to expect and why some studies can be handicapped differently.

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A couple of years ago one of the controversial topics in the Immuno-Oncology space centered around pseudoprogression and whether it was real or not, leading to the development of immune related adverse event (iras) criteria.

Fast forward to Spring 2017 and a new controversy has sprung up, which is focused upon hyperprogression following several publications on the topic.  

It’s a rather nasty situation where people with cancer can rapidly deteriorate and progress faster than normally would be expected.

Is this down to something real associated with the immunotherapy, however, or simply a function of a sick patient taking an inert therapy that takes a while to have an impact?

Strong opinions on the topic have inevitably arose, with different views on whether the phenomenon is real or not and how we could go about assessing and measuring it.  It’s an interesting debate that’s well worth following…

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We have long argued that by the time 2nd Generation CAR T cell therapies hit the market they will almost be obsolete and next generation versions will already be in advanced clinical testing. The product life cycle in this niche is likely to be a very rapid one, much more so than in other areas of cancer research.

The critical question isn’t when these new constructs will be available, but rather what form will they take? What will they look like, and which issues will they address?

Several researchers are leading the way in the CAR T cell therapy space, but a recent presentation by one expert in this field reinforced how he is making a transition from pioneer to disruptor.

In this post we explore some of the issues and ideas he discussed in a vision for the future.

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Wiesbaden, Germany – Last night Bavarian Nordic dropped the unfortunate news that the phase 3 PROSPECT trial exploring the PROSTVAC vaccine in combination with GM-CSF in asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (CRPC) was futile.

Source: Bavarian Nordic

Once you miss the overall survival (OS) endpoint, that’s it folks – there’s no other choice but to say the therapy failed, harsh though that may sound.

There are, however, a number of important points to consider from here that are worthy of further discussion.

Here, we post an analytical review and look at a number of factors that could have impacted the outcome.  It’s rarely one simple thing because the immune system is highly complex and multi-faceted.

Hopefully there will be important learnings from this study that will advance the IO and prostate cancer fields.

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As we demonstrated in the recent Novel Targets podcast that opened Season 3, one topic that is a key focus for many in the IO space is addressing mechanisms of immune escape and acquired resistance to single agent treatment with immunotherapy.

We’ve seen several oncogenic escape mechanisms reported, included activation of the JAK/STAT pathways in some patients and loss of existing immunity when the tumour suddenly becomes cold or an immune dessert.

The good news is that there are a number of ideas that can be pursued, including activating the innate immune system in various combinations.

As we see more companies invest in the innate immunity space in order to have a rational partner with which to combine with their checkpoint inhibitor, it will be important to maintain focus on trial designs and synergistic mechanism of actions to improve efficacy while reducing the potential for overlapping or severe toxicities.

Here’s one intriguing and promising new approach that caught our eye this month that is worthy of researching and following over time…

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Greetings from continental Europe!

ESMO Madrid Conference Center

We have a LOT of data to discuss today from ESMO and have also included an interview with one expert that was conducted under embargo on an important topic.

Of course, the usual in-depth analyses on new targets and early compounds in development will duly follow in the post-meeting output, but there’s plenty of practice changing data to consider and also some results that may trigger alternative thinking from where we are now.

We also received questions from BSB readers on certain trials and some of these are answered in today’s update on the road…

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Sunday is usually a good day at ESMO congresses and 2017 was no different in that respect.

It does feel weird, however, to be seeing tweets about data from some studies hours before they are presented in that day’s Presidential Symposium, something oncologists attending have started to notice too:

Yesterday we had encouraging readouts from PACIFIC and FLAURA trials to discuss, so what’s in store for today? Are they mostly highights or lowlights?

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It really doesn’t feel like a year since we were at ESMO in Copenhagen, in what was probably the most exciting meeting of the year in many ways.

Packed audience!

With the ASCO abstract deadline being in Jan/Feb, ESMO offers a great opportunity for companies to have another major slot in the calendar to present ground breaking data. In some ways, having positive data at a European meeting can actually amplify positive studies that might otherwise get lost in the noise at ASCO, which is almost becoming too big.

So what’s in store now that the meeting is upon us?

There are some large and small trials with important data on the first two days that bear thinking about and further discussion.

Here’s our take on the first batch of readouts, including some surprises…

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This kind of positive news is always nice to wake up and read:

“Rucaparib maintenance therapy increases progression-free survival in BRCA mutant recurrent ovarian cancer by 77%, according to late-breaking results from the ARIEL3 trial reported today at the ESMO 2017 Congress in Madrid.”

Of course, it’s not the first PARP inhibitor to show a significant effect as maintenance therapy in ovarian cancer after initial platinum therapy and we shouldn’t assume that all drugs in the same class will have an equivalent effect until we see the data.

It is good to see confirmation of a positive impact after seeing the data from two plus lines of therapy at ESMO in Copenhagen last fall.

So what does the new readout look like, what can we learn from it, and what were thought leader reactions to the data?

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When we think of pioneers in the CAR T cell therapy space, one person who comes to mind is Waseem Qasim, Professor of Cell and Gene Therapy at the Institute of Child Health at University College London, and a Consultant Immunologist and Pediatrician at Great Ormond Street Hospital (GOSH).

Institute of Child Health

As readers may recall back in 2015, he gave the first allogeneic CAR T cell therapy under compassionate use to an infant with ALL, and in the process undoubtedly saved her life.

The subsequent case report published in Blood was the talk of 2015 annual meeting of the American Society of Hematology (ASH) in Orlando.

The poster focused on the first child that Prof Qasim treated and attracted a phenomenal amount of attention:

Prof Qasim UCART19 #ASH15 Poster

Where are we now with allogeneic CAR T cell therapy?

It’s been 18 months since we spoke to Prof Qasim, so while in London over the summer BSB caught up with him in his office at the Institute of Child Health.

This interview is the first in our latest 3-part mini-series on allogeneic CAR T cell therapy, which runs throughout this week. Here’s a teaser clip:

Kite’s first autologous product, Axi-Cel (in aggressive lymphomas), heads for regulatory approval in the US (PDUFA date November 29th), offering Gilead a hematology launch product with a high unmet need and, presumably, a relatively high price tag to match. Inevitably, some critical attention will subsequently be focused on the pipeline and whether they will move towards allogeneic CAR-T cell therapy (reduces cost of goods and increases profit margin) as well as how the TCR platform in solid tumours will fare.

It’s certainly a timely point to consider allogeneic CAR T cell therapies again given that things are rapidly heating up in the cell therapy niche following the Gilead announcement yesterday that they are acquiring Kite Pharma for $11.9 Billion.

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