Biotech Strategy Blog

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

Posts tagged ‘epacadostat’

Not all high TMB tumours are inflamed…

Discussing the lessons learned from preclinical research or clinical trials, while not a popular endeavour for obvious reasons, are nevertheless an important part and parcel of oncology R&D.

Sometimes we learn more from failure than we do from success.

Other times we can be inspired by some cool science which turns out to be pivotal in changing how we think about future strategies.

In a two-part series from SITC this week we are going to cover some key findings across various talks and posters, which are not simply run of the mill rehashes or perfunctory phase 1 dose escalation studies.

What lies beneath the bonnet for the curious amongst you?

BSB subscribers can read up on our ongoing commentary and analysis from the cancer conference season – you can either log-in or click to access our latest analysis.

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National Harbor, MD – Day 2 of #SITC17 brought some interesting highlights on a number of fronts, not all of which may be apparent at present, but there are a few readouts that will have a broader impact going forward.

SITC 2017 Stars?

As we move into an era where we see more combinations evolve in immuno-onology, things are likely to get more confusing rather than less so and it could well be another 3-5 years before things truly settle down and more concrete trends emerge.

Here, we reviewed 10 different areas of interest with a strong clinical relevance and explored the topics further.

Please note that some of these will also have follow-on posts with thought leader interviews and related poster reviews.

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IDO/TDO inhibition is a topic we’ve been following the progress on for several years now with various updates along the way. It’s also one of our most requested Previews for this year’s ASCO meeting taking place next month.

The Bean, Chicago

In Chicago next month, initial data from several trials is due to be presented.

  • What can we expect?
  • How are the main players in this landscape doing?
  • Will this combination be the next big thing in the oncology IO space?

In our latest #ASCO17 Preview, we take a hard look at IDO/TDO inhibitors.

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Having heard about a one day symposium on immunotherapy organised by Charles River, I headed over to Munich and the EORTC-NCI-AACR conference a day early… Providentially it seems, as the Lufthansa strike will likely affect a few travellers en route to the Triple and ASH/WCLC/SABCS conferences.

cr-ena2016The focus of this excellent one day event was on ‘Mapping the future of cancer drug discovery.’

So what stood out as interesting and intriguing?

Quite a few things, as it turned out, including a novel target in cancer research that I haven’t come across before.

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One of our popular series from conferences is Gems from the Poster Halls, where we take a look at some of the studies or research data that caught our attention and explain how they may have future significance. In the past, posters have lead to phase 2 or 3 trial designs and subsequent approval. Others have sadly missed signals in small studies that could have prevented an expensive phase 3 faiure. Hence, it is often important to pay attention to posters.

esmo16-poster-hall

The ESMO16 Poster Hall Maze

Posters can also give early warning for what’s developing in pipelines. The BTK inhibitor, ibrutinib, was originally codenamed CRA–032765 (at Celera) and later PCI–32765 (at Pharmacyclics), for example, while the PI3K-delta inhibitor, idelalisib started life as CAL–101 (at Calistoga). We previously followed the progress of these compounds while they were in preclinical and phase 1 and documented progress long before they became active drugs in a race to market in CLL.

My favourite codename is always going to be STI–571 (imatinib). We would start planning ASCO and ASH activities every January and September, so companies should be well in hand in their preparations for ASH and SABCS by now. There’s a tremendous amount of work involved behind the scenes in order to have a great event, and I’m not talking about the fripperies like exhibits and light boxes here.

Last year at ECCO, StemCentRx burst on the scene and were subsequently acquired at a significant premium by AbbVie, taking quite a few people by surprise.

So what can we learn about the data from ESMO this year? What new trends are emerging this time around?

Here, we take a fresh look at FOUR interesting new developments from small and large pharma/biotech companies alike in Part 2 of the Gems series. In the first one [Link], we interviewed an expert and discussed their approach to biomarkers in early small studies to help them better design larger follow-on trials more effectively.

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esmo-poster-hallThis post started out as a look a one of the Gems from the Poster Halls at ESMO, including an interview with a thought leader in biomarkers, then morphed into a broader Op Ed that includes a strategic analysis of where we are, where we are going, and how we could get there more effectively and efficiently.

It’s time to turn tables to start challenging the status quo and slow pace of development if we really want to make a difference in advanced ovarian cancer.  I was recently challenged by a well respected GYN oncologist to delineate how we could do things differently so here are some ideas, along with the scientific rationale in my response to his gauntlet.

Is the ideal situation one where multiple companies randomly throw mud at the wall hoping something sticks the best approach? Or are there more effective ways to make a difference?

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SITC Day 3 Highlights

There were a couple of late breakers presented in the oral session yesterday that are worth discussing for several reasons, not least the controversy surrounding the stock action afterwards.

Dr Tara Gangadhar (U Penn) presented epacadostat, Incyte’s IDO1 inhibitor, in combination with pembrolizumab, Merck’s anti-PD1 inhibitor in a phase 1/2 trial with selected solid tumours.

Will combining these agents lead to better responses and outcomes than with pembrolizumab alone?

Dr Naiyer Rizvi (Moffitt) presented the combination data of AstraZeneca’s anti-PDL1 (durvalumab) plus anti-CTLA4 (tremelimumab) in patients with non-small cell lung cancer (NSCLC).

Neither of these agents have yet been approved in any indication, so the only relative comparators we have here are nivolumab and pembrolizumab as single agents in NSCLC and ipilimumab plus nivolumab in metastatic melanoma. There are no data approved for the BMS combo in lung cancer.

This review looks at both trials, in terms of the controversial data presented, and also in a broader context of the ever-changing landscape.

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