Biotech Strategy Blog

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

Posts tagged ‘small cell lung cancer’

Stormy waters – Oncology R&D is a fine line between success and over the edge sometimes!

BSB Reader Mailbag – With the FDA approval of lurbinectedin on Monday and two very different recent announcements regarding adjuvant therapy readouts for CDK4/6 inhibitors, we received a bunch of BSB reader questions on both topics.

It’s been a while since we dived into the mailbag in a busy conference season, so this is a great time to reflect on some broader thoughts in oncology R&D for context.

Here, we look at two key aspects…

  • Am I enthused about the lurbinectedin data or not?
  • What half dozen factors could we be thinking about when considering CDK4/6 inhibitors in adjuvant HR+/HER2- breast cancer in order to decide if one is better than the other or does luck play a part?

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Toronto Skyline for WCLC

There’s a lot going on in lung cancer of late, especially with the World Conference on Lung Cancer (WCLC) taking place in Toronto this week.

Following on from our recent preview, it’s time to take a look at the actual data presented and make an assessment on progress with both targeted and immunotherapies.

Here we offer some thoughts and insights on 16 key trials that were presented…

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One of the challenges of the short whirlwind period between AACR and ASCO is that many new research papers get published and largely missed or forgotten about in the data tsunami that drops as people eagerly (and almost exclusively) focus on the new abstracts that are available.

This is a real shame since there were many really good pieces of research that were rich in knowledge that were published around then.  My reading pile heading into AACR was much larger than usual, and after wading through it all, it built up rapidly again heading into ASCO, never mind over 20,000 abstracts to consider between those two meetings!

Contemplating new data…

With this in mind, it’s time for a new Journal Club post – these are surprisingly popular on BSB, although on reflection the selections have tended to highlight either new targets and areas of therapeutic potential or offer explanations for some of the phenomena that we are seeing.

New developments often (but not aways) allow us to step back and see results from clinical trials with greater clarity.

With this in mind, here are our latest selections for the BSB Journal Club, all of which should prove to be a useful read…

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Last October I posted two updates on small cell lung cancer (SCLC). One explored the broad SCLC landscape, while the second was a detailed analysis highlighting the red and green flags to watch out for in the Rova-T TRINITY study.

My sombre conclusion or prediction, if you will, was not particularly well received at that time:

“My sense is that the median PFS and OS in the allcomer ITT population will remain modest and in line with what we might expect from historical chemos in 3L SCLC.”

Dismal happenings are to be expected…

This morning AbbVie announced that they will not be filing for accelerated approval of Rova-T in 3L SCLC based on the interim analysis.  In other words my expectations for this trial were met, although there are many who will be very disappointed at the results.

What matters though is not just how disappointing topline results might be per se, but why they occurred, what we can do about it, and most importantly, where we go next.  There’s a lot more to this than might initially be obvious from the press release.

That’s what this new post is all about… first a post mortem, then the obstacles to be addressed, and finally, what we can look forward to in SCLC…

On a happier note: there may be some surprises ahead!

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Yesterday in part 1 (Link) of our latest mini-series, we looked at the SCLC landscape and some of the key background issues to think about.

This time around in part 2 we drill down focus more specifically on Rova-T, including physician and patient sentiments and in particular, what to watch out for with the upcoming phase 2 TRINITY readout.   There’s a lot to consider here so we’ve broken the analysis down to five key areas.

Mystic Meg is also back with her canny predictions – what does the crystal ball portend for Rova-T and the TRINITY trial?  Caveat: she’s been on a tear of late; this situation will not continue forever.

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This week certainly turned out to be a defining tale of two drugs with a chequered history…

Lion DancersFirst off, the FDA approved AbbVie/Genentech’s venetoclax, now known as Venclexta, in a subset of CLL patients with 17p deletions. These patients have a historically poor prognosis and the approval goes some way to addressing the high unmet medical need.

Secondly, another biotech company, Clovis Oncology, got slammed by ODAC with a 12-1 vote to wait for phase 3 data from the TIGER-3 trial for rociletinib to better determine the efficacy:safety benefit profile.

For a long while it seemed that AbbVie had nothing but toil and trouble over the tumour lysis syndrome (TLS) issues giving them some significant challenges to overcome, while Clovis were one of the new darlings of Wall Street.

In the final dash to the market, the tables were turned almost at the 11th hour and fortunes stunningly reversed.  Yet a mere eighteen months ago, few industry watchers would have predicted the difference in outcomes.

In our latest AACR Preview series, we take a look at Bcl2 inhibition and where some of the emerging opportunities might lie based on new preclinical research that is being presented here in New Orleans this weekend.  It makes for interesting reading.

While one tiger is licking its wounds, another is smacking it chops at what the future might hold for new combination approaches; how the tails have literally turned.

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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.

Austria SchnappsIn 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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A decade or so ago, the annual conferences for the European Congress of Clinical Oncologists (ECCO) and European Society of Medical Oncologists (ESMO) were considered convenient dumping grounds for negative or failed trials. This was largely because they received much less attention than their big brother, the American Society of Clinical Oncology (ASCO).

In the last few years, this trend has shifted with excellent clincial and scientific data being presented at both meetings – they alternate as hosts each year – under the European Cancer Congress (ECC) umbrella.

Just to confuse a global audience long used to referring to the meetings as ESMO and ECCO, while the logical Twitter hashtag might appear to be #ESMO14 and #ECCO15, respectively, based on the standard nomenclature of conference acronym followed by the year, the vagaries of European politics mean we end up with… #ECC2015.

It will be interesting to see how they compete for attention because this hashtag signal will be dirty (more than one usage) and noisy (many disparate voices) with the European Curling Championship, a European Cheerleader Convention and another on e-cigarettes and vaping, all seemingly using the same moniker!

ECCO 2015 Vienna

Still, what many readers are really eager to learn though, is this a great, middling, or poor year for exciting new data in the field of cancer research and what can we expect to hear about in Vienna later this month?

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Anyone who has been regularly to the American Society of Clinical Oncology (ASCO) over the last decade or two will have have sat through quite a lot of trials with doublets and triplets in numerous advanced solid tumours and seen an impressive graveyard of failed cytotoxics and targeted therapies build up… Too toxic, lack of efficacy, futile even. This is especially true for some of the more difficult to treat cancers such as pancreatic, small cell lung cancer, melanoma, glioblastoma and soft tissue sarcomas.

Chicago Riverwalk

ASCO 2015

There is hope though, after all, things have changed quite dramatically in the metastatic melanoma landscape over the last five years that it is now quite unrecognisable compared to a decade or even five years ago. This is very good news indeed.

What about the other tumour types in that list, though? How are we making progress with those?

In the latest series here on BSB, we’re going to focus on the new developments happening on the fringes of cancer research out of the main spotlight and look in more depth at what’s looking promising in some of these areas. Today, we’re going to start with small cell lung cancer (SCLC), a truly devastating disease with a horribly dismal prognosis.

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