Biotech Strategy Blog

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

Posts tagged ‘lung cancer’

Fearful Symmetry

Palace guard in Stockholm

Stockholm, Sweden – The annual meeting of the European Hematology Association (EHA) is in full swing with updated data from two blue companies, Blueprint Medicines and bluebird bio of interest to BSB readers.

There is often beauty and simplicity to be found in nature that also applies to oncology R&D.

One of those aspects can be found in the concept of targeting particular aberrations or molecular rearrangements that driven oncogenic activity.  Once you connect the dots to arrive at these key targets, you can develop therapeutics that inhibit the activity, resulting in cessation or reduction in proliferation.

In our latest post, we focus on an update on Blueprint Medicine and take a look at their various programs in early clinical development, as they have quite a lot going on with multiple targeted compounds in different areas, including hematology.

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Fitting it all together – what does the post ASCO Lung Cancer Landscape look like?

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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Will KEYNOTE-042 change the standard of care in lung cancer?

Chicago June 3, 2018: The data for the phase 3 KEYNOTE–042 trial has just been presented in the plenary session of the 2018 annual meeting of the American Society for Clinical Oncology (#ASCO18).

Data for this positive phase 3 study was presented by Dr Gilberto Lopes (@GlopesMd), Associate Professor at the Sylvester Comprehensive Cancer Center at the University of the Miami.

The trial in previously untreated patients with metastatic non-small cell lung cancer (NSCLC), who didn’t have an ALK translocation or EGFR mutation, sought to answer the question of whether the anti-PD–1 checkpoint inhibitor pembrolizumab (Keytruda) would be better than chemotherapy in patients whose tumours had an expression of PD-L1 between 1–49%.

Readers may recall that pembrolizumab has already received FDA approval for the treatment of first-line NSCLC in patients with greater than 50% PD-L1 expression, based on data for the KEYNOTE–024 trial that was presented back at ESMO 2016 by Dr Martin Reck.

So what’s the verdict? 

Dr Lopes kindly spoke to Biotech Strategy and shared his perspective on the trial data he shared with ASCO. Will the KEYNOTE–042 trial change the standard of care, and how does it fit in with the KEYNOTE–189 trial data that we heard about at the 2018 AACR annual meeting back in April?

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Learning from IO-IO combo misses

In the frantic rush to the clinic with various IO-IO combinations, many people seem to have forgotten that these have an increased risk of failure than say, combining one IO molecule with chemotherapy.

This risk can take the form of increased toxicities, as well as lack of efficacy, especially if you are giving an unknown therapy instead of one that is known to be effective in controlling the tumour.

We look at a tale of two cities in lung cancer; there are some interesting lessons to be learned here…

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ASCO18 Preview 1 – Magnificence or Atrocious?

The Bean, Chicago

Whenever the Bean photo pops up then you know it marks the start of the annual meeting of the American Society of Clinical Oncology (ASCO).

Ahead of this year’s abstract data palooza, I thought it would be a nice idea to highlight some of the key sessions of interest and important abstracts within.

There are quite a few new molecules to watch out for in early drug development, plus some important phase 3 trial readouts to consider, especially on the combination front.

It will be hard act to beat or even follow the phase 3 lung cancer clinical trials plenary at AACR18 last month, but here goes…

We have selected 11 key areas that may be useful to watch out for as a starting point ahead of the abstract data dump expected tomorrow at 5pm.

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Stacking up evidence from IO clinical trials

What we wanted to accomplish in our latest thought leader interview was to peek under the hood with someone active in this field who is an experienced participant in phase 2 and 3 trials, as well as being a solid translational researcher capable of thinking outside the box critically.

Stacking up the evidence from IO trials

Today we cover a global KOL’s perspectives on cancers of the lung, renal, bladder, and even melanoma, in a wide ranging discussion about immunotherapy trials and some of the pitfalls and opportunities to watch out for.

It makes for an intriguing read as there are likely a few issues that many have not thought about in great depth.

This is an important discussion in the context of not just data that was recently presented at several conferences including AACR, but also with the upcoming monotherapy and chemo combination trials (including squamous and non-squamous lung cancer) expected at ASCO in a few weeks time.

We discuss quite a few of the key challenges and opportunities relating to the broader picture and highlight some of the important issues to watch out for…

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How Charles Swanton plans to revolutionize treatment of Lung and Renal cancers

At the 2018 AACR annual meeting, one of the noteworthy talks given to the 22,000+ attendees in Chicago was a plenary lecture by Charles Swanton from the Francis Crick Institute in London. He’s a Professor of Personalized Cancer Medicine at University College London and chief clinician for Cancer Research UK (CRUK).

Professor Swanton is the leader of a landmark clinical study, TRACERx (TRAcking Cancer Evolution through therapy (Rx)) study, which involves analyzing how cancers and in particular, lung and renal cancers, evolve over time.

There’s a lot of heavy science and jargon inherent in this niche that often frightens off people, but that need not always be the case.

What is fascinating, though, is the very idea that tracking the development of early stage cancers might teach us new insights and lessons about alternative approaches to oncology R&D.

We have all seen the limitations of chemotherapy, targeted therapies and even immune checkpoint blockade, so what other approaches can be considered that link back to the biology of the disease and how it evolves over time?

What we wanted to achieve here was a clear and elegant story about what Prof Swanton and his colleagues are doing, as well as a simple grounding on the basics of disease progression and how that can translate clinically into new therapeutics that might make a real difference to the lives of people with cancer.

It’s a fascinating story and may well be one of the most underappreciated recent developments in cancer research…

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The squamous and non-squamous lung cancer race continues!

At ESMO IO last Fall, Genentech/Roche were first past the post in 1L non-small cell lung cancer (NSCLC) with data from their phase 3 study in non-squamous patients evaluating the combination of chemotherapy and bevacizumab plus atezolizumab versus chemotherapy alone.

The 1L NSCLC race continues apace…

Since then, there has been much anticipatory excitement for BMS and Merck’s phase 3 trials, CheckMate-227 and KEYNOTE189, respectively.  These data will be now presented at the annual meeting of AACR in Chicago next month.

In the meantime, there are also the overall survival data expected soon from AstraZeneca’s MYSTIC trial – will it be positive despite a PFS miss?

Later this year, the company have another study (NEPTUNE) result expected that explores the combination of durvalumab plus tremelimumab versus platinum-based standard chemotherapy in first line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.  This has been a controversial area for IO studies to date and the story here may well be more subtle and complex than many realise.

Next year we can also expect to see more readouts from Pfizer/EMD Serono’s JAVELIN LUNG 100 (avelumab) in both squamous and non-squamous histologies, while AstraZeneca’s POSEIDON study is in squamous patients only.

Just this week, Genentech again announced their phase 3 squamous NSCLC trial readout with positive PFS in favour of the combination of chemotherapy plus atezolizumab versus chemotherapy alone.  The BMS CheckMate-227 study included both sets of histologies and no details were provided in the announcement, so hopefully this data will be available at AACR.

In Pharmaland we hear much noise around First-in-Class and Best-in-Class claims but, ultimately, it will all come down to data.  In oncology, it always does.

In our latest review post, we take a look at both squamous and non-squamous settings and what we learn from the latest available information.  Surprisingly, it’s quite a lot and there are important nuances to consider as well…

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A look at the controversial BMS trial CheckMate-227 in lung cancer

BMS LogoThe big news of interest in the oncology landscape this morning is the BMS announcement that the CheckMate–227 study hit its primary endpoint of PFS under certain conditions in previously untreated non-small cell lung cancer (NSCLC).

We’ve been covering the 1L NSCLC landscape for a while now and this study was one that was less easy to predict than the others for a number of reasons. I’m pleased to say we got it right, although there are quite a few things to learn from this announcement, not to mention some important implications too.

Here, we continue our coverage on this topic with an analysis based on the latest information…

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What can genomics and tumours teach us about cancer drug development?

Non-small cell lung cancer (NSCLC) is big news this morning with the announcement from Genentech/Roche that the IMpower150 trial exploring whether adding atezolizumab to the standard of care Avastin plus chemotherapy hit it’s first co-primary endpoint of PFS. The data will be presented at European Society for Medical Oncology (ESMO) Immuno Oncology Congress in Geneva, Switzerland next month. The other co-primary endpoint, overall survival, is expected in a couple of months.

I’m delighted that this trial hit a positive note, especially after a few folks were surprised at our emphatic positive prediction for both the PFS and OS outcomes in reviews this year when we looked at it in the summer and again in the fall – see: predictions in 1L NSCLC trials followed by red and green flags.

In the meantime, recently there was some very important news in the lung cancer niche relating to the field of genomics and our understanding of how tumours develop and evolve.

It’s easy for many folks to forget that even in a tumour type that is considered to be a hot/inflamed one due to the high tumour mutation burden (TMB), not all patients respond to checkpoint therapy upfront and not all will achieve lasting durable responses that go out five years. Resistance (primary and acquired), as well as immune escape, will inevitably have a large impact on many patients.

Understanding the underlying biology of the disease will not only help us figure out the causes of non-response and relapse, but also explore rational combination approaches that might improve outcomes.

Just as the triplet of atezo/bevacizumab/chemo has now been show to be superior to the control doublet, we may well see other approaches evolve in the near to medium term future.

The Dynamic Duo at #TARGETS17

Up on deck today is a timely yet rare joint interview that explores the science behind how cancers (including lung cancers) evolve and adapt to try and evade not only detection, but also being destroyed, by anti-cancer therapeutics.

Professor Charles Swanton (Crick and UCL) and Dr James Gulley (NCI) make for a thoughtful and compelling double act.

It was an absolute delight and a privilege to conduct our latest BSB fireside chat with them together. What they had to say was fascinating.

Often we have jested about putting researchers in the BSB hotseat, but frankly when it comes to people of this calibre, the tables are usually turned and the interviewer is the one in the hotseat with some selective pressure to keep up and maintain a flow of intelligent questions!

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