Biotech Strategy Blog

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

Posts tagged ‘Breast Cancer’

The White House in spring, Washington DC

With spring in the air and the clock rapidly running down on the annual meeting of the American Association for Cancer Research (AACR) in Washington DC in just two weeks time, it’s time to take a look at the seventh topic in our Preview series.

What’s hot on deck to day?

With increasing competition in the metastatic breast cancer space, particularly in HR+ HER2- disease, it’s time to explore key issues around CDK4/6 inhibitors as there’s a lot going on here, including some important presentations ahead.

A road map of what to expect and what to watch out for is often valuable if you want to avoid surprises.

We also examine key issues the companies here are facing as well as highlighting emerging scientific and clinical data of note on several relevant fronts.

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Today we continue the second of a two part interview with a global thought leader who is also a scientist-clinician and well versed in cancer research as well as clinical trials.

Old Town Hall, Munchen

We explore how we can do clinical trials better in order to learn via a more rigorous process what works, what doesn’t, and why. After all, we we don’t know why certain approaches didn’t work or what the mechanisms of resistance are, how can we possibly improve?

Randomness is not necessarily a good thing in clinical research, especially if you don’t know what target you’re actually trying to hit!

If you missed the first part of this latest KOL interview and want to catch up then you can find it here (Link).

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At the 2016 San Antonio Breast Cancer Symposium (SABCS16), I had the great pleasure to talk with a leading inflammatory breast cancer expert and translational researcher, Naoto T. Ueno MD PhD.

Dr Naoto Ueno at SABCS16

Dr Ueno is Executive Director of the Morgan Welch Inflammatory Breast Cancer Research Program and Clinic at the University of Texas MD Anderson Cancer Center.

He’s active on Twitter where, as @teamoncology, he shares information on the latest developments in breast cancer, often writing in Japanese for his followers.

A cancer survivor himself, he also brings an empathy to patient care through his own treatment experience.

Anyone who follows him on Twitter, will also know he is a “foodie.”  Prior to our chat, I joked he should write the definitive guide to San Antonio restaurants for attendees… he definitely ate better than I did at the meeting!

MD Anderson also has an IBC conference coming up next month for those interested in the area:

What caught my attention at SABCS16 were posters from MD Anderson researchers that offered insight into the challenges and opportunities in targeting this rare form of breast cancer, something we don’t hear a lot about.

Subscribers can login to read the interview Dr Ueno kindly gave BSB or you can gain access via the blue button below… this is the fourth in our series of expert interviews from San Antonio.

If you have a keen interest in IBC, do follow @teamoncology – if you don’t already!

The first day of the 2016 EORTC-NCI-EORTC Molecular Targets meeting brought us chilly weather and a frozen lake outside the conference centre in Munich.  Brrrr!

gluhwein-munchenIt also heralded a great lineup of cancer researchers largely characterised by unconventional thinking. This, of course, is a good thing because it is only by dismissing dogma that a field can move forward unconstrained.

There were several talks that I will come back to in a separate post, but here I wanted to focus on one particularly good talk on breast cancer, something we haven’t covered in a while.

A decade or two ago, breast cancer made a lot of progress – we saw the emergence of gene expression profiling, the identification of different histology types, treatments for hormonal sensitivity or HER2-positivity and then… nothing.  Meanwhile, the issue of drug resistance plagued researchers – why don’t all women respond and why do they become resistant?

In the meantime, we’ve seen a wealth of progress in melanoma, lung, kidney and bladder cancers, enormous strides in hematologic malignancies and many other areas.  Breast cancer, the early star, seems to have faded and we haven’t had much to be cheerful about aside from a few isolated cases.

The good news is that things are a-changin’ though and research is looking more promising as we learn from lessons in basic and translational research and how they can be applied to new therapeutics and drug resistance.

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Copenhagen – it’s the end of Day 2 of the European Society for Medical Oncology (ESMO), which this year had a record-breaking 20,239 attendees.

esmo16-posters

Three of the presentations in today’s plenary Presidential Symposium were simultaneously published in The New England Journal of Medicine – I haven’t seen that happen before.

All three were also featured in this morning’s media briefing in Copenhagen.

  • Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer (NEJM link)
  • Prolonged Survival in Stage III Melanoma with ipilimumab Adjuvant Therapy (NEJM link)
  • Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer (NEJM link)

In today’s daily digest there’s top-line commentary and insights from some of the sessions we attended. In a separate post, we have already discussed the niraparib data.

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For years we’ve followed the trials and tribulations of targeted therapies seeing many approved and quite a few disappear forlornly (and officially) off to dog drug heaven. Many more sit in no-man’s land as companies eagerly wait in a holding pattern for other trial readouts in different tumour types. Sadly, sometimes these studies don’t generate enough compelling data either. With so much competition about, there are no shortcuts or low-hanging fruit in biotech or cancer drug development any more.

ASCO16 Chicago 1

En route to Chicago and ASCO!

Then along came antibody drug conjugates (ADCs), with some encouraging results in a range of cancers in both solid tumours and hematologic malignancies that lead to the approval of several new therapies.

After that, the next big advance was immunotherapies, specifically checkpoint blockade, with encouraging single agent activity in melanoma, lung, and even urothelial bladder cancer. We’ve also seen the promise fo combining two different checkpoints such as nivolumab and ipilimumab together in metastatic melanoma, albeit with an increase in toxicities.

This is all very well and good, although the challenge remains that the majority of patients either respond to therapy and relapse, or do not respond at all, depending on the circumstances, the tumour type and the regimen. We still have a long way to go in moving the needle and creating a new paradigm shift on a broad scale.

So what happens when we start to combine modalities – such as targeted therapies with immunotherapies?

Uh-oh, I hear the distant cries of disagreement erupt…

  • Remember vemurafenib plus ipilimumab in metastatic melanoma was scuppered by severe hepatitis?
  • What about osimertinib plus durvalumab in NSCLC and the increased incidence of ILD?

Both of these statements are true, and yet… we should not assume that all mixed therapy combination approaches are doomed on the basis of a mere n of 2. What happens if some are synergistic or additive? What happens of there are hidden gems that teach us new ways of doing things rather than doing the same old thing just because it’s always been done that way?

With this in mind, I’d like to open the door on our first ASCO 2016 Preview series with a look at novel combination approaches in development that caught my eye.

What are the early hints and signals that we can learn from the data? Which companies are evaluating imaginative new ideas that may turn the tables on traditional thinking?  The ideas discussed here may well surprise a few people.

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We’ve had a couple of requests come in for a revival of the old conference series… ‘Gems from the poster halls’ because quite a few folks are interested in the up and coming data from small to medium biotechs.

SABCS San Antonio CrowdA bunch of my Post Doc chums in this field were at the San Antonio Breast Cancer Symposium (SABCS) meeting and gleefully highlighted mobbed posters or areas where they thought the data looked potentially interesting.

From these, we selected a few for review in today’s look at the nuggets that can be gleaned from cool and intriguing trials or preclinical research that may influence future trials.

Companies covered in this article include Seattle Genetics, Jounce, Immunomedics, Syndax and MedImmune.

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Biomarkers are a hotly debated topic at the moment within the cancer immunotherapy field.

At the recent Society for Immunotherapy of Cancer annual meeting (SITC 2015), there was even a debate with industry representatives arguing the “pros” and “cons.” Daniel Chen, MD PhD from Genentech (pictured right) argued “pro” and Steven Averbuch MD (pictured left) from BMS argued “con.”

SITC 2015 Biomarker Debate

The challenging question for anyone at the moment is if your Parent, Spouse or Best Friend were PD-L1 negative, would you still want them to receive a PD-1/PD-L1 checkpoint inhibitor (presuming it was indicated for the disease) and have a chance of a response, even if their PD-L1 negativity would suggest only a slim chance of responding?

AT SITC 2015 we spoke with an industry expert who offered insights into a leading company’s biomarker strategy and what the future may look like in 5-7 years time.

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Beyond the late breaking abstracts and plenary sessions at the European Cancer Conference being held in Vienna, Austria later this month, what other important topics can we expect to hear about?

ECCO 2015 Vienna

We covered the former in the last article on Biotech Strategy Blog, today we turn our attention to the proffered (oral) sessions and what we can learn from those sessions and the expected data that is due to be presented.

There are a number of interesting topics and new data slated for presentation that are worthy of review and highlighting in a What To Watch out For (W2W4) format.

Here’s our take on the potential highlights at the meeting.

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Have you ever sat in a freezing cold scientific session and been so engrossed in the compelling presentations that followed, you simply forgot to take notes? Not one. That actually happened to me at the American Association for Cancer Research (AACR) in Philadelphia this year in one of the many fringe sessions that I attended.

Reading Terminal Clock

Reading Terminal Clock, Philadelphia

Granted, the hot topic of the conference was undoubtedly checkpoint inhibition, but I was anxious to escape to the comfort of some meaty and familiar basic and translational science, namely MYC.  MYC is largely thought to be a difficult to target, even undruggable protein, and along with RAS and p53, represents a formidable challenge for cancer researchers.  These three oncogenic proteins alone are probably responsible for more drug resistance developing and even death from cancer than any other proteins in a patient with advanced disease.

For cancer patients with advanced disease, the clock is ticking on time they have left.

Solve these three problems (MYC, RAS and p53) and we may have a shot at dramatically improving outcomes. As Dr Gerard Evans (Cambridge) noted:

“I think it’s fair to say that we don’t really know why interruption of any oncogenic signal actually kills cancer cells, but one of the reasons that we’re interested in MYC is because it seems to be a common downstream effector of many, maybe all cancers.”

Sure, the road to success is paved with an enormous graveyard of failures, just as metastatic melanoma was before checkpoint blockade came along, ironically.  What I heard at AACR both inspired and filled me with greater confidence… we’re finally getting somewhere.

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