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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At the European Cancer Conference (ECC 2015) held in Vienna recently, a number of promising targets emerged along with new drugs in development in several different tumour types. Not all of them were from big Pharma – some were from up and coming young biotechs that will be worth watching out for.
In this first part of our ‘New Drugs on the Horizon’ mini series, we chose four interesting and largely positive studies to highlight and discuss in-depth.
In the past, there were many negative trials to pick over and ponder why they didn’t quite pan out. After all, it’s relatively easy to be an armchair critic and hindsight is a wonderful thing.
Picking only four from the many promising choices of trials presented this year available turned out to be quite hard given there were many that caught our attention – a bit like choosing only one of four out of the many schnaps to sample locally!
Today’s review looks at four very different drugs and approaches in early development from Pfizer, Stemcentrx and Ignyta – they include encouraging early data on both small molecule tyrosine kinase inhibitors (TKIs), as well as antibody drug conjugates (ADCs).
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Sarcoma is something we call one disease but actually represents 50-70 different histologies, which poses challenges for drug development. Not only do you have to identify what’s the unique target, but it’s hard to accrue patients into trials, when a major center may only see a few of each sub-type.
Soft tissue sarcoma is an area of unmet medical need, and one I have been interested in since launching Gleevec in GIST (way back when) when I was fortunate to get to know many of the leading sarcoma experts.
George D. Demetri, MD. Photo Credit: DFCI
One of these is Dr George Demetri, who is Director, Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.
At the recent European Cancer Congress in Vienna, I had the privilege to talk with Dr Demetri about some of the latest research in soft tissue sarcoma.
We spoke about cancer immunotherapy, new small molecules and monoclonal antibodies, and the potential of targeting the epigenetic machinery.
A lot of what Dr Demetri is doing is currently “under the radar” and while he didn’t give any secrets away, he did give some sense of where some breakthroughs may occur in the not too distant future. He also talked about how sarcomas with a specific target can be used for proof of concept clinical trials of novel agents.
Given the pressure that many companies are under to speed up their path to market strategies, accelerated approval in a rare tumour subset is one approach that can be considered.
It’s an exciting time in the field with the potential for several agents in development to move the needle and make a difference. I hope you enjoy this post, it was a real pleasure to talk with Dr Demetri again.
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Vienna, Austria: it’s day 2 of the European Cancer Congress in Vienna (Twitter #ECC2015).
Along with 18,000+ attendees we’re looking forward to hearing about some more practice changing data.
Today in Vienna brings another busy and jam packed day at the European Cancer Conference (ECC). We’ve already reached the point where the days blur and you have no idea which day of the week it actually is, you just follow the next fresh day in your personalised program or schedule.
So what’s in store today?
This morning brings updates on lung cancer, including the much anticipated atezolizumab results in POPLAR and BIRCH, as well as urothelial bladder cancer from the IMVigor trial. There is also a melanoma session that includes the oncolytic virus T-VEC, together with pembrolizunab and cobimetinib in separate study readouts. All this before lunch!
The afternoon promises to be equally interesting with an Immunotherapy in Cancer session that includes nivolumab, pembrolizumab plus we get our first look at a novel immunocytokine targeting CEA-IL2. A parallel session explores the science behind brain tumours with presentations on the tumour microenvironment, biomarkers and current trials.
In the meantime, the embargoes lift at 7am CEST on several studies including the atezolizumab data, which we highlight here.
To learn more about our insights throughout the day, including the latest immuno-oncology perspectives – some of which is potentially practice changing – subscribers can log-in or you can sign up in the box below.
After an entertaining morning yesterday – two interviews completed and wrong conference centre visited (yes really, there’s always a first for everything!) by lunchtime, things thankfully settled down.
Friday, for the uninitiated, is company symposia day – the equivalent of ASCO’s Super Friday. I rarely attend these in Europe, as they are more about corporate messages than what I call “proper CME”, meaning scientific or clinical fair balance and independence. This is one area where Europe still has a-ways to catch up the US on.
Before anyone gives me a hard time on this, I’ll never forget a vendor telling me a couple of years ago that I would love a particular symposia as he had personally ‘supervised and written’ the slides for the event, thus ‘ensuring’ it would be excellent while persuading me to attend against my better judgment. Naturally, I hated it – too many company messages or perspectives, and not ones I agreed with either – and left early, sadly disappointed.
We did attend the first ECC Press Briefing Friday afternoon with Drs Sant, Chouieri and Sharma. The last two authors presented on the metastatic renal cell carcinoma (mRCC) data after initial therapy, which is being presented in the Presidential Symposium on Saturday morning. It was quite an eye opener in many ways, with some subtleties well worth exploring in additional analysis and discussion.
Beyond the obvious highlights of the day for Saturday (nivolumab and cabozantinib data in mRCC), the first official day here is pretty jam packed with lots of other data to ruminate over. Throughout the day, we’ll be adding additional notes, commentary and insights as the data emerges – and wifi permits.
To learn about our insights and thought leader perspectives of the relapsed/refractory mRCC data, subscribers can log in or you can sign up in the box to learn more.
LONDON – atezolizumab (Roche/Genentech) is expected to change the standard of care (SOC) for the treatment of metastatic urothelial bladder cancer. That’s the key message I took from a recent interview with Professor Tom Powles (Barts Cancer Institute) on the role checkpoint inhibitors and cancer immunotherapy will play in the treatment of bladder cancer.
Readers will recall the compelling early phase 1 clinical trial data for atezolizumab (formerly MPDL3280A) that Prof Powles (pictured right) presented just over a year ago at the 2014 ASCO annual meeting: “Making a difference in advanced bladder cancer”
Although other checkpoint inhibitors are in bladder cancer trials, and we have written about the pembrolizumab (Merck) data first presented at ESMO 2014 (“Breathing New Life into Bladder Cancer Treatment”), it is expected that atezolizumab will win the race to market in the US and be the first checkpoint inhibitor to gain FDA approval for the second-line treatment of advanced bladder cancer.
Atezolizumab received breakthrough therapy designation (BTD) in May 2014 from the US Food and Drug Administration for PD-L1 positive metastatic urothelial bladder cancer after progression or intolerance of platinum based chemotherapy.
Earlier this summer Genentech announced in a press release that the IMvigor 210 phase 2 study was positive and met it’s primary endpoint, with a greater response rate associated with higher levels of PD-L1 expression.
This data will be presented on Sunday Sept 27 as a late-breaker at the forthcoming 2015 European Cancer Congress in Vienna (Twitter #ECC2015), the European equivalent of the ASCO annual meeting organized in alternate years by ECCO and ESMO:
Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210)
Although we won’t know the trial results until they are presented in Vienna by Dr Jonathan Rosenberg (MSKCC), based on the recent press release it’s widely expected that the positive data from this trial will lead to rapid regulatory approval in the United States.
Subscribers can login below or you can purchase access to read Prof Powles’ opinion on the role checkpoint inhibitors will play in the treatment of bladder cancer, how this may play out in Europe as compared to the United States, and what the future may hold beyond checkpoint monotherapy.
This interview does not discuss the data to be presented at the 2015 European Cancer Congress, the results of which we will have to wait until Vienna to hear.