Biotech Strategy Blog

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

Posts tagged ‘NSCLC’

Not in San Diego – In normal times of past years, the AACR annual meeting generally takes place once a year in April before we haed onto oter events such as ASGCT, ASCO, and EHA. In these abnormal times in the middle of the COVID–19 pandemic, however, the virtual event was split into two, with the first online event in April covering mainly early clinical data, and now we get to learn from the meaty scientific presentations, which are being highlighted this week.

A network of mutations, tumour suppresses, metabolic and immune processes, as well as other hidden factors can unexpectedly impact therapy outcomes in NSCLC

We have a lot of translational researchers reading BSB, so I wanted to kick off the first of the AACR Virtual Meeting series with a scientific focus, which is likely of interest to many for a number of obvious reasons.

The good news is this a topic we have covered before and so there’s already a body of work to build on for reference since this latest round of information not only adds to what we know, but also highlights some additional unknown unknowns yet to be elucidated.

The dichotomy is an essential part of the very essence and fun of science – the more we think we know, the less we really know in practice, especially as the various layers of the onion get gradually peeled off over time.

This latest review mixes up translational research with clinical research…

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Time for some additional colour commentary!

There has been some incredibly intense interest surrounding TIGIT as a new therapeutic target in oncology of late, to the point where some observers have been wildly claiming this is the new universal checkpoint everyone has been waiting for.

But is it?

It’s early days yet with little data presented from people with cancer, so at this point it could well be a bit of a stretch to find another anti-PD–1/PD-L1 equivalent, but this doesn’t mean there isn’t utility in seeing clinical activity in some tumour types, far from it.

In our latest post, we take a look at what’s coming up in the TIGIT niche, along with an interview from a company active in this niche.

What do the company have to say and how do they see this panning out?

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There’s a lot of hype and noise of late surrounding the Iovance TIL therapy licensed under a CRADA from the NCI based on Dr Steven Rosenberg’s work.

Another Brick in the Wall for TIL therapies?

A few years ago many acadenics vehemently argued that TILs wouldn’t go much further than metastatic melanomas (cutaneous or uveal) and certainly there were dramatic responses seen from the before, during and after photos, as anyone who attended AACR in 2013 will attest.

Seven years on, the TIL topic is back in fashion again – is the hype justified or are the plaudits based more on a wing and a prayer?

We have some firm views to share on this topic…

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National Harbor, MD

With the abstract drop from the 2019 Society for the Immunotherapy of Cancer (SITC) meeting now available, what can we learn from some of the research slated for formal oral presentation this year?

Here in part one (posters will be reviewed tomorrow) we take a look at a mix of preclinical and early clinical studies that grabbed our initial interest from the oral presentations – they include the good, bad, and intriguing – to see exactly what can be learned from this year’s mix of abstracts?

The short answer is quite a lot.

Every year the what to watch out for preview is a popular one.  This year there are some surprises in store as well as some particularly important findings that BSB readers may well be keen to find out more about ahead of the conference later this week in order to maximise their thinking and avoid the inevitable brain-fry and fatigue that sets in on Saturday afternoon…

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Barcelona – Today is going to be a very long and complex day at ESMO, with a multitude of key data expected from several trials ranging from the phase 1 Amgen data update on their KRASG12C inhibitor, AMG 510, AstraZeneca’s osimertinib in the FLAURA study plus a raft of others, including the phase 3 PAOLA–1 and CheckMate–227 trials.

In order to keep all the information straight and manage the various embargo deadlines at wildly different times, we’re going to break with tradition and post three different articles at different times on KRAS, FLAURA, and the daily running log of various studies and posters that catch our interest. Yes it’s a lot more work, but it’s the only way to manage all the deadlines!

This post will focus solely for the KRAS updates at ESMO19, including the initial data release, the presentation, analyses, and commentary. No doubt that means a series of updates will ensue so do check back regularly or follow the alerts on Twitter via @biotechstrategy.

Let’s roll!

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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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Until recently, we followed the race to market in EGFR T790M lung cancer with Clovis’s rociletinib and AstraZeneca’s osimertinib (Tagrisso).  In phase 2, AstraZeneca caused quite a stir when they came from behind and leapfrogged their biotech rival with a large global randomized controlled trial seemingly out of nowhere.  They never looked back.

Can they do the same thing with durvalumab (Imfinzi), one of their IO therapies that targets PD-L1?

If there’s one thing that many astute observers of the IO space have learned this week it’s that irrational exuberance and the hopeful sentiment that ‘everything’ will just tweak the immune system and work positively no matter what has thankfully come to an end.

We’ve seen several highs and lows already with Merck’s pembrolizumab gaining accelerated approval in 1L NSCLC in allcomers when combined with chemotherapy and AstraZeneca reporting positive phase 3 data for durvalumab in unresectable (stage 3) NSCLC based on meeting the study endpoint (PFS).

There is much to be learned because the nivolumab disaster in 1L NSCLC last year was not a singular aberration given that durvalumab has seen some missteps in the past and even atezolizumab had some unexpected news with urothelial cancer this week (Check out our insights), as compared to chemo in the second line setting. Just like mutations, there will be many more to come, perhaps even some additional ones before the year is out.

What about today’s news from AstraZeneca in unresectable NSCLC?

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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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Yesterday saw the FDA approval of atezolizumab (Tecentriq) for the second-line treatment of metastatic non-small cell lung cancer (NSCLC) (link to company press release).  According to Genentech:

“This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that TECENTRIQ helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.”

The FDA approval is largely a broad one in 2L and 3L across PD-L1 expression and histologies [Link]:

“TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.”

The approval was widely expected in light of the Phase III OAK trial data presented in the Presidential Symposium at ESMO16 meeting in Copenhagen.

Sign adjacent to #ESMO16 in Copenhagen

Sign adjacent to #ESMO16 in Copenhagen

Imagine hearing live about positive first-line data with pembrolizumab, with and without chemotherapy, negative data from nivolumab in the same setting, the 2L data for atezolizumab and two discussants drilling into both the data and broader impact of these studies to a jam packed audience that even included thought leaders from other tumour types who were also eager to hear the news. To say the atmosphere was electric would be a rather British understatement here.

We previously covered our initial impressions from that session [Link], but we also had the pleasure and privilege of interviewing a leading US thought leader in the lung cancer space after the session to garner his impressions of the data and also some perspectives on the key issues that the field is facing.

The pembro plus chemo data is already providing some controversy amongst various protagonists given there are a number of similar combination trials expected to read out over the next year to 18 months, plus much anticipation from analysts regarding the ditching of chemo for IO combos such as anti-PD–1 plus anti-CTLA–4 (BMS and AstraZeneca have keen stakes here), but what do thought leaders really think of that concept? Is that the slam dunk that many analysts seem to think it is?

This, my friends, is where things start to get a lot more complicated, akin to 3D chess in Star Trek.

What is happening now in advanced NSCLC is not how the market will look in a year or two. In many ways, the rate of approvals are outstripping the pace of science right now, but once the low hanging fruit is gone, competition will need to evolve in much more sophisticated and elegant levels.

With these questions in mind, we have a double header for you today – you can read on to find out more details from our latest though leader interview, supported by some insightful perspectives from a medical oncologist who treats lung cancer patients in private practice. Today’s post therefore covers some wide ranging discussions across the key issues in advanced NSCLC and it’s future direction.

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Please note that subscription prices will increase on Monday 24th, so if you’ve been on the fence about our upcoming coverage of #SITC2016, #ENA2016 (EORTC/NCI/AACR Mol Targets), #ASH16, #SABCS16 and #JPM17 then now is a good time to lock in at the current rates!

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BioTwitter is all a-flutter today with the announcement from BMS that the CheckMate–026 trial in first line non-small cell lung cancer (NSCLC) comparing nivolumab (Opdivo) to chemotherapy did NOT meet its primary endpoint of progression-free survival (PFS).

The news was not entirely a surprise to us at BSB, here’s why…

Figurative statute representing Science on Holborn Viaduct in City of London.

Figurative statute representing Science on Holborn Viaduct in City of London.

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