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!
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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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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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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There can be no doubt that immuno-oncology is a hot topic in cancer research of late with checkpoint inhibitors, immune agonists, immunocytokines, CAR T cells, TILs, TCRs, not forgetting innate immunotherapies. We’ve written extensively about many of these topics, but what about the companies behind them and their strategies?
One thing subscribers tell us they love reading about here on BSB is not only fireside chats with thought leaders, but also interviews behind the scenes with company personnel, be scientists, clinicians or CSOs.
Recently, we’ve posted some interviews with Roche and Genentech scientists/physicians about their IO platform that were well received. Today, it’s the turn of AstraZeneca and MedImmune, who are also developing checkpoint inhibitors and immune agonists against various cancers.
With the anti-PD1 antibodies i.e. Merck’s pembrlizumab (Keytruda) and BMS’s nivolumab (Opdivo) already approved by the FDA, and Roche/Genentech’s atezolizmuab well on the way to filing in advanced urothelial bladder cancer with the announcement this week that the IMvigor 210 trial in relapsed/refractory disease met its primary endpoint, the big question now remains is what’s happening with the fourth element of the quartet? How well is progress coming along there and what is the main focus we can expect in the near future?
Like most Brits, when AstraZeneca noted back in 2013 that they expect to establish their global R&D hub in Cambridge, I assumed they meant in the Golden Triangle and not Massachusetts. This is a burgeoning area for European biotech research, which is somewhat ironic after the KuDos scientists working on olaparib (Lynparza) moved to Alderley Park in Cheshire with the acquisition and will likely face moving back again!
At ASCO, we had the pleasure of a chat with Dr Rob Iannone, the head of the AstraZeneca Immuno-oncology development program. The company also published a number of interesting abstracts and posters that were on show in Chicago, as well as a burgeoning pipeline in this area beyond their lead compounds, the anti-PDL1 inhibitor, durvalumab (MEDI4736) and tremelimumab (anti-CTLA4).
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We know from preclinical research that immunosuppressive tumour microenvironments can restrain anti-tumour immunity, thereby making subsequent therapeutic interventions less effective than expected. CD40 activation has been shown to reverse immune suppression and drive antitumor T cell responses, which in turn could lead to potentially better outcomes.
What happens when patients with advanced melanoma are given a checkpoint inhibitor plus an immune agonist such as anti-CD40?
Can we help the non-responding patients to checkpoint blockade improve their outcomes and shift the long tail in survival curves up using this approach?
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