Biotech Strategy Blog

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

Posts tagged ‘nivolumab’

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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Can TMB help select patients for lung cancer therapy or not?

Chicago!

One of the key topics arising out of probably the hottest session (lung cancer clinical trials plenary) at AACR last week was tumour mutation burden (TMB).

An important question to be addressed was whether or not the nivolumab plus ipilimumab combination from the CheckMate–227 study will be useful in previously untreated non-small cell lung cancer (NSCLC) patients with a high TMB?

There are a number of questions that occurred to us that need careful consideration:

  • Is TMB ready for prime time?
  • What are the challenges and issues involved?
  • How useful are the data from CheckMate–227 and CheckMate–568?
  • Where are we going next?

To find out more, we had some fascination discussions at AACR with two up and coming young researchers from industry (Dr David Fabrizio of Foundation Medicine) and academia (Dr Nicky McGranahan from UCL in London), who are both experts intimately involved in measuring TMB.

What did they had to say and what does it all mean?

Their candid answers may well surprise a few people…

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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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Report on key data in GU Cancers from ASCO-SITC 2018

At the inaugural event in Orlando last year, one of the highlights for me was learning how important CD38 might turn out to be as another immune checkpoint target in combination with other approaches.

This year the meeting moved to the west coast and was held in San Francisco, making it the third one this month after JPM18 and GI18. Indeed, the fourth such event is also rapidly coming up with ASCO GU next month!

So what did we learn this time around? Quite a lot it would seem.

While much of the clinical data of late associated with immune checkpoint blockade (ICB) has been in metastatic melanoma and non-small cell lung cancer (NSCLC), two other tumour types that have received increasing attention in the IO space have been clear cell renal carcinoma (ccRCC) and prostate cancer.

There were a few interesting new things we can learn here…

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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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Tears Before Bedtime…

After writing about the 1L NSCLC landscape every quarter last year, I was thinking the other day that we were due another update and discussion on this riveting topic again soon and added it to the editorial calendar of topics to write about on BSB.

It was therefore no surprise to hear Merck’s announcement this morning that their phase 3 trial KEYNOTE-189 exploring pembrolizumab plus chemotherapy hit its co-primary endpoints and is now the second study to do so after Genentech/Roche’s announcement for atezolizumab plus chemo plus the VEGF inhibitor, bevacizumab was a success.

Are we at a crossroad for lung cancer?  With many more readouts yet to come competition in this space is certainly heating up dramatically!

Meanwhile, there are a few important implications to consider here, so we sat down and penned an update based on the emerging data and highlight some key insights to consider…

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