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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This is the third in our mini-series previewing the forthcoming European Society for Medical Oncology 2016 Congress in Copenhagen (Twitter #ESMO16).
In this post we’re taking a look at what’s hot in head and neck cancer.
It’s not a cancer type we typically hear a lot about, but there’s an unmet medical need for effective new treatments.
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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!
If 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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One of the exciting developments in metastatic urothelial carcers of late has been the emergence of checkpoint blockade with some very encouraging signs of durable clinical activity. Urothelial cancers comprise a group of urinary tract tumours including bladder, penile, ureter etc, although most trials tend to enroll bladder cancer patients, where there is a high unmet medical need.
View from the 95th floor of the John Hancock Center, Chicago
This year alone has seen the FDA grant AstraZeneca with breakthrough therapy designation for durvalumab in February, while Genentech/Roche subsequently received approval for atezolizumab (Tecentriq) based on phase 2 data on May 18th.
To put these developments in context, the last FDA approval in metastatic urothelial carcinoma was almost 4 decades ago in 1978 for the chemotherapy cisplatin!
As is often the case in Pharmaland, once one company starts exploring a therapy in a given tumour type, others will quickly follow. Already we have several immunotherapy agents being evaluated in urothelial carcinoma both in early and metastatic disease, so what can we learn from the data presented at ASCO last week and where is the landscape going in the future?
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The 10 abstracts selected here are actually not in order of magnitude, preference or weight… with the lone exception #1, an incredible piece of work that was a decade in the making.
Few of these choices are in the press briefing, none are in the Plenary session – they’re often hidden gems that many will miss in the hurly burly of the data drop and noise.
They’re also 10 abstracts that I feel are worthy of highlighting with some additional commentary.
Some of the ideas here illustrate some intriguing trends that are emerging, others may have a big impact on the cancer immunotherapy space, either because of the novel concept idea, or because the data are very compelling, if you understand the science.
You can decide for yourselves – which ones would you pick and why?
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After looking at one important poster yesterday on multiple myeloma, it’s time to explore other equally interesting targets in other tumour types.
Some years reflect the inertia that hit oncology R&D with a lot of old data rehashed or they can be flooded with many me-too compounds. Not this year, there’s a lot to talk about and review… so much so that we may well have enough for three rounds of Gems from the Poster Halls, time permitting as ASCO is fast approaching!
Without much further ado, for round 1 we have explored eight posters spanning four companies with a variety of different targets including chemotherapy, targeted therapies and immunotherapies. I will say though, that the lines are being blurred as all of these modalities can impact the immune system, sometimes in unexpected ways.
What’s in store for today? A focus on biotech companies doing intriguing cancer research.
Companies mentioned: Infinity, Innate, Incyte, Agenus
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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With the recent approvals of nivolumab (Opdivo) and pembrolizumab (Keytruda) in advanced lung cancer as well as new checkpoint inhibitor data presented on atezolizumab at the European Cancer Conference in Vienna, there are several new lung cancer immunotherapy controversies to consider such as…
- How do we choose between docetaxel chemotherapy versus anti-PD1/PD-L1 immunotherapy?
- Which checkpoint should we choose?
- Is the PD-L1 biomarker useful and important?
- Do the company assays differ?
Dr Jack West
Dr Jack West (Seattle) got the ball rolling on some of these issues earlier this month, generating quite a spirited and useful debate on Twitter, demonstrating that clinical decisions in this area are not as cut and dried as many might think.
In addition, we spoke to a number of lung cancer experts in Vienna for their perspectives on the data, the biomarkers, treatment paradigms and other critical issues.
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On Friday last week, AstraZeneca confirmed that their combination trial for osimertinib, as it’s expected to be called or AZD9291, as it’s more commonly known (anti-EGFR mutant, T790M inhibitor) plus durvalumab (MEDI–4736, anti-PD-L1) in non-small cell lung cancer (NSCLC) is on clinical hold following an increase in ‘interstitial lung disease-like reports.’
As companies with checkpoint inhibitors and other immunotherapy agents expand beyond monotherapy into logical combinations, is the risk of increased ILD from combining an EGFR inhibitor with a checkpoint something other companies need to watch out for?
By the way, we strongly disagree with the reported conclusion of Goldman Sachs on this issue – and here’s why…
Today’s article explores this controversial issue in more depth.
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Beyond the late breaking abstracts and plenary sessions at the European Cancer Conference being held in Vienna, Austria later this month, what other important topics can we expect to hear about?
We covered the former in the last article on Biotech Strategy Blog, today we turn our attention to the proffered (oral) sessions and what we can learn from those sessions and the expected data that is due to be presented.
There are a number of interesting topics and new data slated for presentation that are worthy of review and highlighting in a What To Watch out For (W2W4) format.
Here’s our take on the potential highlights at the meeting.
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