Biotech Strategy Blog

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

Posts tagged ‘pembrolizumab’

What can we learn from early IO trials?

SITC Phase 1 Review Part 1 – It’s time for a two-part mini-series on recent phase 1 clinical trials and how to interpret the findings.

Are we at a crosswords with IO combos?

As a former new products development professional, this is something that I’m particularly enthusiastic about.

While it is fascinating to see other people’s reactions to early oncology trials, these should often be taken with a very large pinch of salt, in my view.

In Part 1, it’s time to take a step back and understand not only what companies are doing, but also how they set the trials up and what they are looking for. We highlight some examples of data readouts to illustrate the points.

In Part 2 on Monday we take a rock around the clock at some of the other recent phase 1 readouts and explain what we can learn from what was presented. The devil is often in the small details that many observers miss at first glance.

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Fitting it all together – what does the post ASCO Lung Cancer Landscape look like?

It is always a pleasure to talk with experts who have a clear vision of not just what the current treatment landscape looks like, but where the field is going.

Dr Stephen Liu at ASCO18

Dr Stephen Liu is a medical oncologist and assistant professor at Georgetown University Medical Center in Washington DC, where he specializes in thoracic oncology.  He’s also actively involved in clinical trials and developmental therapeutics.

We last interviewed him at ASCO 2016 – you can also hear him on Episode 13 of the Novel Targets Podcast – where he shared his thoughts on some of the early lung cancer immunotherapy combination trials underway.

As regular readers know, we like to follow stories over time and also catch up with thoughtful, intelligent people we’ve talked to in the past whose opinions we value.

Dr Liu kindly shared his highlights of ASCO 2018 in lung cancer, and in a wide ranging discussion, also offered some thoughts on what the future may hold and where we may be going next.

There was a lot to learn from Chicago this year, with plenty of nuances and subtleties to consider. If you read only one post on lung cancer from ASCO18, this interview tells you all you need to know!

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Stacking up evidence from IO clinical trials

What we wanted to accomplish in our latest thought leader interview was to peek under the hood with someone active in this field who is an experienced participant in phase 2 and 3 trials, as well as being a solid translational researcher capable of thinking outside the box critically.

Stacking up the evidence from IO trials

Today we cover a global KOL’s perspectives on cancers of the lung, renal, bladder, and even melanoma, in a wide ranging discussion about immunotherapy trials and some of the pitfalls and opportunities to watch out for.

It makes for an intriguing read as there are likely a few issues that many have not thought about in great depth.

This is an important discussion in the context of not just data that was recently presented at several conferences including AACR, but also with the upcoming monotherapy and chemo combination trials (including squamous and non-squamous lung cancer) expected at ASCO in a few weeks time.

We discuss quite a few of the key challenges and opportunities relating to the broader picture and highlight some of the important issues to watch out for…

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The PD-1 Gorilla is Back!

At AACR last week we had the long awaited initial readouts for three key phase 3 studies in lung cancer, namely CheckMate–227, IMpower150, and KEYNOTE–189 in the same session on the same day.

This had me thinking about how it might end up being, “a killer and a chiller and a thriller when I get the (PD–1) gorilla in Manila,” with sincere apologies to Muhammed Ali and Dr Jean-Charles Soria for (mis)appropriating their past themes 😉

Chicago River Bridge at #AACR18

For those attending the event, you might well be forgiven for thinking from the first two adjectives that I’m referring to the weather, as it was certainly cold enough (!), or even the results this week from AstraZeneca’s unfortunately named ARCTIC study exploring the IO-IO combo of durvalumab plus tremelimumab in the third line setting with a miss in both PFS and OS endpoints.

In reality, we should be warmed and heartened to see three positive immunotheraopy trials appear at once and presented in the same session at the same meeting.  It isn’t always the case as regular attendees at ASCO well know.

When all is said and done, what do thought leaders specialising in lung cancer really think about the data that was presented in Chicago, and what were the convergence and discord on the various key issues under consideration?  There is, after all, a lot of subtlety and nuance to consider in 1L NSCLC.

To find out more, we interviewed not one, but four, lung cancer specialists in Chicago for their personal perspectives.  What they had to say as a group was both candid and absolutely fascinating, so it made sense to curate their insights around various key topics together into one detailed post for easy reading… 

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AACR18 Red and Green Flags in 1L NSCLC

Chicago: It’s been a crazy busy day here at BSB, with embargoes, key data, thought leader interviews around town, the poster hall and plenty other things to think about.

What I wanted to do here was take a step back after the dramatic 1L NSCLC session and pull together some pros and cons that oncologists will be thinking about going forward.

There’s a lot going on in this market that is worthy of further discussion and debate…

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The path to success in 1L NSCLC

Things are heating up rapidly in the 1L non-small cell lung cancer (NSCLC) space with the latest news that Merck’s pembrolizumab beat out chemotherapy as monotherapy in previously untreated stage 4 patients in KEYNOTE-042.

Is the path to success is a rocky road for some companies in 1L NSCLC?

BMS’s trial in this setting, CheckMate-026, previously failed to show any benefit for nivolumab over chemotherapy, so what gives?

There is no doubt that Merck have been on a roll in lung cancer of late with nary a false step with pembrolizumab thus far.  Is that down to luck or careful preparation?  Are there differences in the molecules or trial designs?

Here, we take a look at the two situations and continue our ongoing analysis as these results certainly offer a ‘tale of two cities’ perspective in the same indication.

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Can we predict early treatment discontinuation on immune checkpoint therapy?

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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How will the RCC landscape change – who dares, wins?!

For what seems the longest time, we have seen the battle in metastatic clear cell renal cell carcinoma (ccRCC) being focused on various anti-VEGF TKIs, whether against interferon, mTOR inhibitors, and even each other.

Lately, anti-PD(L)1 antibodies have also come on the scene – both as monotherapy and in different combinations – so are things set to change?

Will it be plaining sailing or are there hidden dangers ahead for the unwary?

Here, we take a look at the ever evolving landscape in RCC and explore the issues and challenges surrounding some of the novel combination readouts, including a look at the role immuno-oncology might play going forward.

Not surprisingly, there’s a lot to consider, discuss and think about…

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The death of PD-L1 in urothelial cancer

Prof Tom Powles GU18 Title SlideAt the 2018 ASCO Genitourinary Cancer Symposium, one of the standout keynote lectures was from Professor Tom Powles, Director of the Bart’s Cancer Cancer Center in London who talked about “Immune checkpoint inhibitors in Urothelial Cancer: which one and why?”

We’ve been following the highs and lows around checkpoint inhibitors in bladder cancer for some time, so it was interesting to hear what Prof Powles had to say in San Francisco.

How does he see the landscape evolving for immune checkpoint inhibitors?

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ASCO GI18 Preview

San Francisco

The first cancer conference of 2018 is now upon us and after enjoying last year’s event in San Francisco, I wanted to take some time to explore some key abstracts of interest at the ASCO GI meeting, which begins tomorrow.

This conference covers various updates on new developments in oesophageal, gastric, colon, pancreatic and colorectal cancers.

Are there any trials or new developments to get excited about at this year’s GI18 meeting?

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