Biotech Strategy Blog

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

Posts from the ‘Lung Cancer’ category

The PD-1 Gorilla is Back!

At AACR last week we had the long awaited initial readouts for three key phase 3 studies in lung cancer, namely CheckMate–227, IMpower150, and KEYNOTE–189 in the same session on the same day.

This had me thinking about how it might end up being, “a killer and a chiller and a thriller when I get the (PD–1) gorilla in Manila,” with sincere apologies to Muhammed Ali and Dr Jean-Charles Soria for (mis)appropriating their past themes 😉

Chicago River Bridge at #AACR18

For those attending the event, you might well be forgiven for thinking from the first two adjectives that I’m referring to the weather, as it was certainly cold enough (!), or even the results this week from AstraZeneca’s unfortunately named ARCTIC study exploring the IO-IO combo of durvalumab plus tremelimumab in the third line setting with a miss in both PFS and OS endpoints.

In reality, we should be warmed and heartened to see three positive immunotheraopy trials appear at once and presented in the same session at the same meeting.  It isn’t always the case as regular attendees at ASCO well know.

When all is said and done, what do thought leaders specialising in lung cancer really think about the data that was presented in Chicago, and what were the convergence and discord on the various key issues under consideration?  There is, after all, a lot of subtlety and nuance to consider in 1L NSCLC.

To find out more, we interviewed not one, but four, lung cancer specialists in Chicago for their personal perspectives.  What they had to say as a group was both candid and absolutely fascinating, so it made sense to curate their insights around various key topics together into one detailed post for easy reading… 

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Can TMB help select patients for lung cancer therapy or not?

Chicago!

One of the key topics arising out of probably the hottest session (lung cancer clinical trials plenary) at AACR last week was tumour mutation burden (TMB).

An important question to be addressed was whether or not the nivolumab plus ipilimumab combination from the CheckMate–227 study will be useful in previously untreated non-small cell lung cancer (NSCLC) patients with a high TMB?

There are a number of questions that occurred to us that need careful consideration:

  • Is TMB ready for prime time?
  • What are the challenges and issues involved?
  • How useful are the data from CheckMate–227 and CheckMate–568?
  • Where are we going next?

To find out more, we had some fascination discussions at AACR with two up and coming young researchers from industry (Dr David Fabrizio of Foundation Medicine) and academia (Dr Nicky McGranahan from UCL in London), who are both experts intimately involved in measuring TMB.

What did they had to say and what does it all mean?

Their candid answers may well surprise a few people…

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To be or not to be…

After yesterday’s notes on the exciting lung cancer clinical trials plenary, I received a bunch of questions from readers following yesterday’s analysis of the 1L NSCLC market.

This is a good opportunity to take some time out to answer some of them, as they highlight some important points worth discussing, clarifying and reviewing.

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The path to success in 1L NSCLC

Things are heating up rapidly in the 1L non-small cell lung cancer (NSCLC) space with the latest news that Merck’s pembrolizumab beat out chemotherapy as monotherapy in previously untreated stage 4 patients in KEYNOTE-042.

Is the path to success is a rocky road for some companies in 1L NSCLC?

BMS’s trial in this setting, CheckMate-026, previously failed to show any benefit for nivolumab over chemotherapy, so what gives?

There is no doubt that Merck have been on a roll in lung cancer of late with nary a false step with pembrolizumab thus far.  Is that down to luck or careful preparation?  Are there differences in the molecules or trial designs?

Here, we take a look at the two situations and continue our ongoing analysis as these results certainly offer a ‘tale of two cities’ perspective in the same indication.

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Is there a silver lining in SCLC?

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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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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Tears Before Bedtime…

After writing about the 1L NSCLC landscape every quarter last year, I was thinking the other day that we were due another update and discussion on this riveting topic again soon and added it to the editorial calendar of topics to write about on BSB.

It was therefore no surprise to hear Merck’s announcement this morning that their phase 3 trial KEYNOTE-189 exploring pembrolizumab plus chemotherapy hit its co-primary endpoints and is now the second study to do so after Genentech/Roche’s announcement for atezolizumab plus chemo plus the VEGF inhibitor, bevacizumab was a success.

Are we at a crossroad for lung cancer?  With many more readouts yet to come competition in this space is certainly heating up dramatically!

Meanwhile, there are a few important implications to consider here, so we sat down and penned an update based on the emerging data and highlight some key insights to consider…

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IMpower150 lung cancer trial provides a window to the Future of Immunotherapy

Geneva: At the ESMO IO 2017 conference underway in Geneva, the data of the meeting is the IMpower150 phase 3 trial data that will be presented later today by Dr Martin Reck (Grosshandsdorf).

Genentech/Roche have announced a press release ahead of the presentation (Link).

This is the first phase 3 lung cancer immunotherapy trial that combines a VEGF inhibitor (bevacizumab/Avastin), along with a PD-L1 checkpoint inhibitor (atezolizumab/Tecentriq) together with chemotherapy (carboplatin plus paclitaxel).

While we’ve not seen the actual data curves yet, we spoke to Dr Dan Chen (Genentech) about what we can expect to see later today in Geneva, and importantly, we also discussed the significance of the findings from the IMpower150 study.

As Dr Chen told BSB, “this trial is a lot of firsts.”

If you have an interest in lung cancer or immunotherapy, do follow #ESMOImmuno17 on Twitter, as this is data could potentially be practice changing and have a major impact on the lung cancer treatment landscape.

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SCLC – An in-depth look at ROVA-T and TRINITY

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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