Biotech Strategy Blog

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

Posts tagged ‘neoadjuvant breast cancer’

Cui bono?

Imagine arriving at ESMO19 at the crack of dawn for a press briefing and you’re not presenting until after 4.30pm!

To whom is it a benefit is a fundamental principle in modern day medicine given the often vast array of options that oncologists may have at their disposal.

Conversely, we also need to know nec refert – for whom it doesn’t matter or doesn’t benefit – since we don’t want to over-treat people either.

Between those two extremes might be a couple of sweetspots i.e. one subset who may need a boost from chemotherapy and another in whom chemo plus IO therapy might be a better option.

For sure, we are not advocating that all people with early stage triple negative breast cancer (TNBC) should receive the same thing and certainly not everyone will need checkpoint therapy, no matter what the intent-to-treat (ITT) curves or response rates might try to imply.

There’s a lot of factors to think about and consider so here we look at the KEYNOTE–522 data in neoadjuvant and adjuvant TNBC and unearthed with some solid evidence that might help us understand and think about what needs to be done.

Following on from our in-depth ESMO19 Preview on TNBC and what to watch out for, we also now have a thought leader interview to share plus several other commentators chipping in…

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Morning, morning, where’s the strong hot java today?

Barcelona – Here we are on the third day of ESMO 2019 and this is where many presenters and attendees (especially international ones) start to hit the wall with a combination of tiredness, sore feet, late nights, lack of coffee, and jet lag all combine to create a perfect storm of exhaustion.

No matter – the conference schedule marches on!

After the craziness of posting not one, but three, extensive long form posts with commentary and analysis yesterday, I’m delighted to only have to worry about managing the daily highlights today. We’ve also been busy conducting interviews, running round the poster halls and listening to some elegant science talks as well.

If you’ve missed the rest of our ESMO19 coverage, it’s building up nicely so far on this magazine page – do check it out and take your pick of topics to browse.

There are some key phase 3 readouts expected in breast cancer alone, plus a raft of Developmental Therapeutic updates to ponder as well.

As usual, we start off with some known highlights and then move on to updating on oncologic developments that catch our attention through the day.

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#ASCO17 Poster Hall aka rugby scrum

There were a lot of gems in the poster halls at ASCO this year, a fact that is partly a reflection of the wealth of new data with various IO combos and also the early cutoff date.

Now I jested before the meeting that these sessions were akin to a rugby scrum and lo and behold (see photo right) they were even more jam packed than usual!

If you wanted to best the eager and energetic Wall St analysts then remembering your ruck and maul skills were not a bad thing to have in muscle memory… It was not something I attempted in the Go-Cart this year for fear of bowling people over in the stampede to nab the QR codes 🙂

Much of the previous readouts have been with monotherapy in immunogenic tumours such as melanoma, lung, bladder, gastric, renal cell carcinoma etc. Objective response rates in metastatic triple negative breast cancer (TNBC) have generally been under 20%, however.

Lately, the focus has turned to the deepening of responses in these tumours with various combination approaches and also moving earlier in the disease setting, where immunotherapies might be expected to be more effective with a lower tumour burden.

While in Chicago, we spoke to a breast cancer specialist about where IO combos are going and his thoughts on future opportunities in our third post in a series on various aspects of new developments in breast cancer.

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This last week saw the ASCO Breast Cancer Symposium in San Francisco, although very little caught my attention from a drug development point of view. Much of the attention seemed to be focused on surgery, genetic counselling and screening.

With the 2014 European Society of Medical Oncology (ESMO) conference in Madrid coming up fast in only 2 weeks time, it seems a good point to take a look at what’s on the slate there, since there are some important clinical trials being presented there with new data that we can expect to hear a lot more about.

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Companies mentioned: Roche/Genentech, GSK, Novartis, AstraZeneca, Medivation, Astellas
Drugs mentioned: Pertuzumab, trastuzumab, lapatinib, PI3K inhibitors, olaparib, enzalutamide

There are a couple of important breast cancer trials with data being presented for the first time at Madrid.

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One area that is finally seeing a lot more research results of late is neo-adjuvant therapy in breast cancer, i.e. therapeutic intervention prior to surgery.

The main advantages of neo-adjuvant over adjuvant therapy are:

  1. If it works, then the therapy allows the margins to shrink prior to surgery, potentially making the tumour easier to excise
  2. If therapy works prior to surgery, you know what will likely be effective post surgery, whereas in adjuvant treatment after surgery, this is unknown.

One of the leading trials for neoadjuvant breast cancer was the ISPY2 (Investigation of Serial studies to Predict Your therapeutic response with imaging and molecular analysis 2) study.  I wrote about it in more detail at the time it was launched on Pharma Strategy Blog, if you need more information. Basically, the study is based on a complex adaptive conjoint design in neoadjuvant breast cancer, so over time, additional arms were added to the study (there were originally four) while others were removed. In this way, the investigators can find the best therapies for each tumour subtype (HER2+/1, ER+/- or triple negative) based on the responses and biomarkers.

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This morning Dr Hope Rugo, Professor of medicine and director of breast oncology and clinical trials education at UCSF, presented the first ever efficacy results from the I-SPY 2 trial in neoadjuvant breast cancer during the San Antonio Breast Cancer Symposium (SABCS) press briefing.

The complex adaptive phase 2 trial design was developed by Dr Laura Esserman, Professor of surgery and radiology at UCSF and Dr Don Berry, Professor of biostatistics at MD Anderson Cancer Center. Dr Berry was no doubt very familiar and experienced with this concept from the adaptive BATTLE trials in lung cancer that MD Anderson have previously completed.

The data discussed here is from one arm from the study, which currently evaluates different investigational regimens in 7 different arms.

The overall goal of the I-SPY 2 experiment was to screen a series of novel agents in combination with standard chemotherapy in the neoadjuvant setting. Patients were randomized to receive a novel regimen given in combination with standard chemotherapy, or standard chemotherapy alone.

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