Biotech Strategy Blog

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

Posts tagged ‘tremelimumab’

A rare dry spell in Barcelona as the clouds roll in bringing yet more rain

Barcelona – While the weather for the World Congress on Lung Cancer (WCLC) has been largely gloomy with plenty of rainy spells, there’s much good news to report on the clinical front.

After yesterday’s review of the Amgen KRAS inhibitor data in G12C mutation positive patients receiving AMG 510, it’s now time to turn our attention to immunotherapy developments with several important trial readouts and in-depth analyses to discuss.

We will be posting a separate summary of the key highlights on targeted therapy, but first let’s consider what we learned on the immunotherapy front, including some of the science behind it all…

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The 2019 annual meeting of the American Society of Clinical Oncology (Twitter #ASCO19) is now in full swing, and we’re kicking off our on-site meeting coverage with a review of the some of the highlights of Friday here in Chicago.

In today’s Daily Highlights we offer seven areas of interest and offer commentary on the insights gleaned from the data that is rolling out so far…

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AstraZeneca miss on OS in the phase 3 MYSTIC trial – what next?

Getting there… in 1L NSCLC

At one point we were posting almost quarterly updates on the runners and riders in the 1L NSCLC niche and what a roller coaster it has turned out to be!

There have been some successes, failures, and even mixed results so far, suggesting that there’s no room for complacency here.

Previously, AstraZeneca were the first to readout out on PFS in the MYSTIC trial and missed, meaning they had to go to the back of the queue and patiently await the OS data. Since then, we’ve seen several phase 3 trials from Merck, Genentech/Roche and BMS all readout without any real rhyme, reason or consistency between them.

Now AstraZeneca are back in the spotlight with a not altogether unexpected miss on median OS.

It’s easy for people to kick a dog when it’s down rather than take a moment to reflect on the deeper meaning – what does the result mean both for the company and other key players in this highly competitive landscape? What can we learn from this experience and other recent results?

To answer that, we put some insights and analysis together in our latest update on the space…

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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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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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There has been considerable focus on the impact of cancer immunotherapy and checkpoint blockade in particular in non-small cell lung cancer (NSCLC) of late, with approval of several agents in the 1L and 2L metastatic setting, as well as positive results reported in stage 3 unresectable disease earlier this year.

To date, the approvals have focused on monotherapies in second-line (nivolumab, pembrolizumab and atezolizumab) allcomers, as well as in 1L in two cases i.e. for people who are PD-L1 High expressers (≥ 50%) for pembrolizumab or allcomers in combination with chemotherapy (pembrolizumab).

Today as part of their 2Q earnings call details, AstraZeneca ($AZN) announced that the MYSTIC trial exploring the combination of the anti-PD-L1 antibody, durvalumab (Imfinzi), plus anti-CTLA–4 antibody, tremelimumab, unfortunately missed the interim endpoint of progression-free survival (PFS).

This is the first dual IO-IO combo readout in this setting and while disappointing, the results aren’t entirely surprising, as regular readers will no doubt realise.

We are now awaiting several other trial readouts in 1L NSCLC, including Merck’s phase 3 confirmatory trial for pembrolizumab plus chemo and Genentech/Roche’s IMpower150 trial, which explores atezolizumab in combination with chemotherapy, with and without the anti-VEGF inhibitor, bevacizumab (Avastin).

For historical reference, we originally wrote up our perspectives on the 1L NSCLC landscape in January this year then followed that up with a provocative post outlining out predictions on what to expect earlier this month, including the projected miss in PFS for AstraZeneca’s IO combo.

So what does this latest data mean for AZN?

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Over the years we’ve interviewed folks from numerous pharma and biotech companies here on BSB, including those with targeted therapies (small and large), as well as immunotherapies.

Some companies have small pipelines and may be forced by circumstances to explore what they have or seek collaborations with bigger partners.

For big pharmas with large pockets plus broad and deeper pipelines, the challenge is quite different – how do you prioritise potential combinations and tumour targets given it is impossible to evaluate them all in the clinic? How do you create differential advantage and value when you’re relatively later to market compared to your competitors?

In the BSB spotlight this week we have two researchers in clinical development and R&D from the same company, who happen to have both elements in their pipeline in areas of high competition.

Part one of our latest mini-series explores the IO side of the business as we look ‘Through the Keyhole’ at what’s going on in terms of biomarkers, monotherapy trials, combination studies (both IO-IO and IO-targeted) and what to expect in the near-term future later this year. It’s a wide ranging, candid, and fascinating discussion that highlights a lot of potential in terms of what could happen with a large pipeline.

In all, it makes for rather interesting reading and certainly changed how I perceived the company’s efforts in the IO sphere (for the better, I might add).  So what’s fascinating about their approach and what can we learn from their progress to date?

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There’s no secret or surprise with our latest AACR Preview as this week the focus takes a slight turns or detour to the annual meeting of the Society for Gynecology Oncology being held in National Harbor, Maryland.

PARP inhibitors in ovarian cancer have been a hot topic since last autumn when the PARP inhibitor data dropped at ESMO in Copenhagen, and was not without controversy either.

We’ve been following the trials, tribulations and even machinations, of the clinical development of olaparib, rucaparib and niraparib for a while now so what’s in store in the latest round of salvoes?

And importantly, what else can we expect to see in DC at AACR next month?

For a tumour type that hasn’t received much attention over the last decade or two, things are distinctly picking up.  Is it all good though?

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Challenges and Opportunities in the evolving 1L NSCLC Landscape

Rolling English Landscape in Devon

Following a series of events – from BMS’s failure with nivolumab monotherapy… to Merck’s sudden announcement to file their combination of pembrolizumab plus chemotherapy… to AstraZeneca’s delay of the MYSTIC trial exploring durvalumab plus tremelimumab this week, there’s never a dull moment in lung cancer!

So can we expect some more surprises in store in 1L NSCLC?

I say yes we can!  

The big questions are what are they and what impact will they have?

2017 is ironically, the year of the Rooster – so who’s going to crow loudly at dawn and who is going to get strangled in the process?

In the world of cancer research it is unlikely that everything wins or is successful, so figuring out the early signs and hints is an important part of the process.

One thing I learned early in this business is that it pays for companies to be humble, flexible and open minded rather than arrogant and dogmatic in their thinking… otherwise you can easily be blindsided.

There were a few examples of that in oncology R&D last year, a repeat could very well follow in 2017 for the unwary.

Here we look at 1L NSCLC in the context of multiple phase 3 trials that are slated to read out… from AstraZeneca, BMS, Merck and Genentech.

If you want to know what the potential impact of these events are on the landscape, including what we can expect from MYSTIC, CheckMate-227 and several others, then this is the post for you because some surprises are likely in store.

We cut through the chase to explain the what and the why in clear simple language.

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The 2016 Congress of the European Society for Medical Oncology (ESMO) is fast approaching. It takes place next month from October 7th to 11th and we will be on site covering the meeting for Biotech Strategy Blog. We’re looking forward to a great meeting!

ESMO 2016 CongressIf you are sitting on the fence as to whether you should go to Copenhagen, then hopefully our series of Previews will help you decide.

Be warned that accommodation is in already in short supply and ESMO are now putting people up across the Oresund bridge in Malmo, Sweden.

The Congress App has a lot of useful information and is well worth downloading, if you haven’t done so already.

Last week many of the late breaking abstract (LBA) titles were announced, although there are still some placeholders. While we won’t know the actual late-breaking data until the meeting, the LBA titles offer insights into what will be presented in Copenhagen.

In the second in our ESMO 2016 Preview series, we’re highlighting the lung cancer late breakers that we’re looking forward to hearing, providing some background on why they may be of interest, and a look at how some of subset landscapes may be a-changing in the future.

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