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

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At the recent 2016 San Antonio Breast Cancer Symposium (SABCS16), Cascadian Therapeutics (NASDAQ: CASC) presented a poster (Abstract #P4–21–01) on:

“Efficacy Results of a Phase 1b Study of Tucatinib (ONT–380), an Oral HER2-Specific Inhibitor, in Combination With Capecitabine and Trastuzumab in HER2+ Metastatic Breast Cancer, Including Patients with Brain Metastases.”

Tucatinib is an oral tyrosine kinase inhibitor that is highly selective for HER2.

Cascadian’s tucatinib poster at #SABCS16

We’ve seen several new treatments approved for HER2 positive breast cancers in recent years including four targeted treatments: trastuzumab, pertuzumab, lapatinib and T-DM1.

Other companies such as Puma Biotech (NASDAQ: PBYI) also have oral TKIs in development. Puma’s drug, neratinib has, however been shown to have a high incidence of grade 3+ diarrhea, raising questions about its tolerance.

At SABCS16 (Abstract P02–11–03), the company presented the interim analysis of an open-label, multicenter phase 2 trial, which explored their compound:

“Incidence and severity of diarrhea with neratinib + intensive loperamide prophylaxis in patients (pts) with HER2+ early-stage breast cancer (EBC).”

There has been a lot of interest and controversy in this space, so it’s time to take a look at the latest events in HER2+ breast cancer and consider the ramifications since there are a number of new developments that are well worth following, including neratinib (Puma Biotech) and pertuzumab (Genentech).

This is our final expert interview from SABCS – if you missed it you can catch up with the rest of the conference coverage and thought leader sentiments here.

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Dr Max Wicha is the 2016 recipient of the AACR Distinguished Lectureship in Breast Cancer Research. At the 2016 San Antonio Breast Cancer Symposium (SABCS16) he gave his award lecture, “Targeting Breast Cancer Stem Cells: Challenges and Opportunities.”

SABC16 Dr Max Wicha Award Lecture

As the AACR press release notes, “This lectureship recognizes an outstanding scientist whose work has inspired or has the potential to inspire new perspectives on the etiology, diagnosis, treatment or prevention of breast cancer.”

Dr Wicha is a pioneer in the field of cancer stem cells, and is Director Emeritus of the University of Michigan Comprenhensive Cancer Center and a co-founder of OncoMed Pharmaceuticals (NASDAQ: OMED).

Targeting cancer stem cells is an area I expect we will hear a lot more about, particularly in breast cancer. Dr Wicha kindly spoke to BSB after his award lecture, which was one of my highlights of SABCS16.

In case you missed it, do check out the post from the 2016 EORTC-NCI-AACR Molecular Targets Symposium in Munich that featured Dr Mina Bisell (Berkeley), who was a previous recipient of the AACR Distinguished Lectureship in Breast Cancer Research award in 2012 (Link.)

This is the fifth in our series of expert interviews from the 2016 San Antonio Breast Cancer Symposium.

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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. 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!

We’re continuing our series of posts from the 2016 San Antonio Breast Cancer Symposium (SABCS) with an expert interview on how circulating tumor DNA could change breast cancer treatment.

There has been a noticeable increase in attention and focus on the application of liquid tests – especially from blood – over the last five years, culminating in a spinoff company called Grail from the deep sequencing giant, Illumina, announcing a massive funding round earlier this month.

At the time of the BSB expert interview in San Antonio, we had no idea that the Grail news was going to hit just a couple of weeks later!

While much of the media attention surrounding Grail has focused on the early detection of cancer in apparently healthy individuals, there’s actually a much more useful application where it could be more immediately applied to great effect.

Circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) has the potential to revolutionise and improve monitoring over time for people with cancer who are receiving therapy.

This is the third in our series of expert interviews from the 2016 San Antonio Breast Cancer Symposium (#SABCS16).

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At the 2016 San Antonio Breast Cancer Symposium (#SABCS16) one of the mini-symposia that caught my attention was on “Harnessing the Immune System in Breast Cancer.”

A line-up of top researchers and clinicians shared the latest on breast cancer immunotherapy:

  • Laurence Zitvogel MD PhD (Gustave Roussy), “From Breast Cancer Surveillance to Immunotherapy
  • Leisha Emens MD PhD (Johns Hopkins), “Breast Cancer Immunotherapy: Building on Clinical Success”
  • Andy Minn MD PhD (Univ of Pennsylvania): “Identification of Resistance Mechanisms to Checkpoint Blockade for Cancer”
Dr Laurence Zitvogel SABCS16

Dr Laurence Zitvogel at SABCS16

Readers of the blog will recall we last spoke with Dr Emens at the AACR 2015 annual meeting (is it really that long ago?!) where she presented the first data for the PD-L1 checkpoint inhibitor atezolizumab in Triple Negative Breast Cancer (TNBC). See post: “Checkpoint data rocks AACR 2015.”

You can also hear Dr Emens talk about the data on Episode 1 of the Novel Targets Podcast.

What’s new in breast cancer immunotherapy and how have things advanced since then?

At SABCS16, we heard about a novel immunotherapy strategy targeting adenosine in breast cancer, and the trial with an adenonsine antagonist, CPI-444 (Corvus Pharmaceuticals, NASDAQ: CRVS) that’s now underway.

Last September, Corvus senior scientist Stephen Willingham, PhD and Chief Business Officer, Jason Coloma, PhD spoke to BSB about the data they were presenting at the 2016 CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference in New York. See post: “Corvus moves fast to target the tumor microenvironment and improve checkpoint responses.

Corvus had a presentation at the 2017 JP Morgan Healthcare conference (#JPM17) yesterday, and we’ve included some additional commentary on that in this post.

After the SABCS16 cancer immunotherapy mini-symposium, Dr Leisha Emens, Associate Professor of Oncology at the Johns Hopkins School of Medicine, kindly spoke to BSB.

Dr Leisha Emens SABCS16

Dr Leisha Emens at SABCS16

She’s one of the rock stars of breast cancer immunotherapy, and it was truly a pleasure to catch up with her again in San Antonio.

This is the second in our series of expert interviews from #SABCS16. In case you missed the prior posts and want to bookmark for the upcoming ones, you will find them on the conference page (Link).

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We’re kicking off the first in a mini-series of expert interviews from the 2016 San Antonio Breast Cancer Symposium #SABCS16 with a leading researcher who has discovered a first-in-class compound that shows preclinical promise in several cancers including multi-drug resistant metastatic breast cancer.

It has a novel mechanism of action: 

“Interestingly, it was the only molecule, out of the 150,000 we screened that seemed to work through this pathway.”

To go from “bench to bedside,” and take this drug into the clinic now requires funding beyond what academia can provide.

If you’re at #JPM17 and into early stage VC funding or are in pharma/biotech business development BD&L and are on the look out for an innovative new licensing/investment deal, this post is for you.

What makes this a great story is I heard that one “missing piece of the jigsaw” in working out the pathway through which the drug worked came from unrelated research presented at a seminar on wound healing in zebrafish!

As a 2013 article by Robin McKie in The Observer notes, zebrafish (Danio rerio) share 70% of our genes, which makes them pretty cool research models. They are also transparent.

Hearing this anecdote reminded me of my conversation with Dr William Pao that you can hear on Episode 3 of the Novel Targets Podcast where he astutely said:

 “You never know where things are going to lead, you just have to be able to take advantage of them.”

That could also be a metaphor for life.

Science is about making sense of connections and patterns, which is why funding of basic science is so important. A piece of work by one researcher can unlock a breakthrough by another in a totally unrelated area.

While I was doing this SABCS16 interview, I was also reminded of the story behind the development of enzalutamide, and how AACR past-president Dr Charles Sawyers pitched his UCLA drug discovery work to several major pharma companies, without success, until Dr David Hung at Medivation took the risk… and the rest is history.

What makes that story so surprising is at the time Dr Sawyers already had a track record of success with his work on the development of imatinib!

It was a privilege to talk with a senior scientist at #SABCS16 who has thought outside of the box, made scientific connections, and in the process developed a new drug that shows exciting preclinical promise.

Improving the outcome for cancer patients requires the translation of basic science into new products that enter clinical trials.

I do hope funding will be forthcoming to move this first-in-class drug into the clinic so that’s its potential can be fully evaluated.

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If you’re at #JPM17, it’s a great time to buy a sub to BSB and put it on your expenses!

John P. Leonard, MD is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell in New York. He’s a Lymphoma specialist.

Dr John Leonard at ASH16

Like many hematologists, he’s embraced Twitter as way to share his expertise with others in the hematology community. You can follow him at @JohnPLeonardMD.

Over the last couple of years prior to the ASH annual meeting, Dr Leonard has highlighted 10 lymphoma abstracts that caught his attention. You can tell he gets excellent social media pickup by the fact he’s even generated a hashtag to make them easy to find: #Leonardlist and other hematologists generate conversations around his eagerly awaited picks:

In case you missed them on Twitter, and in the spirit of David Letterman, Dr Leonard took me through this year’s #LeonardList and thoughtfully explained in detail why each selection made the cut… for oncology watchers, the why is often more important than the what.

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Like migrating birds, the San Antonio Breast Cancer Symposium (SABCS) has many regular attendees who return each year to enjoy the location and opportunity to hear about latest advances in breast cancer. One leading academic clinician told me she’d been to every meeting for the past 20 years.

The Alamo, San Antonio TX

The Alamo

SABCS offers a unique mix of academic and community doctors, translational researchers, basic scientists and patient advocates. The only downside is that at times the meeting (to an outsider) does feel like a club or family with it’s own idiosyncrasies.

This year, a leading breast cancer oncologist characterized the meeting to me as a “negative one,” meaning several clinical trials were presented that reported essentially negative results.

Although these are an important part of science, and it was good to see them presented, like most of the media, even medical oncologists want to see the “positive” news and that’s understandable. There was no practice changing phase 3 data as in previous years. The trial we most anticipated being at SABCS was delayed due to slow events and that’s a good sign as it most likely means women are living longer…

As readers of the blog will know, we’ve yet to find a medical/scientific meeting that did not offer up pearls, and #SABCS16 was no different in this regard.

Whether you have to spend time in the poster halls or go to obscure sessions, they are there to be found somewhere.

I came away from #SABCS16 with fresh insights into new targets, biomarkers, and also how the world of cancer immunotherapy will interface with genomics. It is these advances in basic and translational science that drive future clinical research.

Experts I spoke to at San Antonio were generous with their time and insights and we’ll be rolling out a series of thought leader interviews in Q1, 2017.

In this post, I wanted to set the scene with what I thought were 3 trends emerging from SABCS16. This is of course, an entirely subjective choice and if you went to the meeting, and/or are an expert in the area, your list would most likely be different.

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If you’d like to buy a quarterly subscription as a gift for someone, do contact us and we can arrange for it to be set up to run from the New Year in the recipient’s name.

The 2016 annual meeting of The American Society of Hematology (ASH) is rapidly approaching and starts later this week on Friday in San Diego (Twitter #ASH16).

ASH15 Late Breaker Session“Super Friday” at ASH, as it’s commonly known, is a day typically associated with satellite symposia, where company’s and organisations sponsor or give unrestricted grants for continuing medical education (CME) around a specific topic or theme. These are professionally produced events that offer fair balance and a line up of experts.

There are also scientific workshops and unofficial meetings not part of ASH….so if you have plans to be in San Diego on Friday where should you be? 

I’m flying in late Thursday and have carefully reviewed all my options for Friday, of which there were many.

ks-beerdetail-2016-03-rtaOne now jumps out to me as a “must attend” and I’m afraid it’s not drinking a Red Trolley…. You’re welcome to join me or can maximise your mileage by going to another event and avoiding duplication of coverage.

Tomorrow @MaverickNY will be kicking off her coverage from Munich and the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium (Twitter #ENA2016) before flying to San Diego on Friday.

If you’re hoping for coverage of World Lung from Vienna, I’m afraid that fell through the cracks thanks to it’s change of date from September to December and the clash with ASH who always hold their annual meeting around the same time.

After #ASH16 I’ll be doing the “on, on, on” to San Antonio for #SABCS16. It’s going to be a busy 2 weeks!

Happy Cyber Monday! Subscribers can login to read my ASH16 Super Friday Preview or you can purchase access. 

Copenhagen – Day 3, Sunday at #ESMO16 was a day to remember on many levels. From being carried forward by a rush of people as a massive crowd was finally let into the Presidential Symposium…

Large crowd of delegates wait patiently to enter ESMO16 Presidential Symposium

Large crowd of delegates wait patiently to enter ESMO16 Presidential Symposium

…to hearing an outstanding discussion of data by one of Europe’s leading lung cancer experts, Professor Jean-Charles Soria (@jsoriamd). He was insightful, engaging, as well as funny in places and was a hard act to follow…

Prof. Soria discussing KEYNOTE-024 data at ESMO 2016

Prof. Soria discussing KEYNOTE-024 data at ESMO 2016

The end result was a day to remember, most significantly it was one where we heard data that will change the standard of care in front-line non-small cell lung cancer (NSCLC), with the expected approval of pembrolizumab (Keytruda) for patients whose tumors have a high expression of PD-L1 (50% or more).

We’re continuing our daily digest of highlights from sessions we attended at the 2016 European Society for Medical Oncology (ESMO) Congress here in Denmark.

nyhavn-denmark

The sun has not shone much here in Denmark during the Congress, the above photo of Nyhavn was taken just before the meeting started, but the data at ESMO16 has shone brightly with two more publications online in The New England Journal of Medicine to coincide with their presentation in Sunday’s Presidential Symposium:

Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer (NEJM link)

Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck (NEJM link).

This mini-series of daily digests over the 4 days of the Congress is intended to give subscribers a finger on the pulse on some of the buzz and conversation…. and occasionally an alternative perspective. We’ll be writing more detailed posts as part of a post-conference series.

In this post, @MaverickNY offers her topline impressions of the lung cancer data presented in the Presidential Symposium, how this will change how some patients are treated, and the resulting impact on the lung cancer landscape. Cancer Immunotherapy continues to drive changes in clinical practice, and is doing so at a very remarkable pace.

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