Biotech Strategy Blog

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

Posts from the ‘breast’ category

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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The most common cause of breast cancer death is when metastatic ER+ tumors develop resistance to treatment.  There remains an huge unmet medical need for new effective treatment options.

One translational clinical researcher leading the way in understanding the molecular and genomic landscape in ER+ metastatic breast cancer is Nikhil Wagle, MD (@Nikhilwagle), Deputy Director, Center for Cancer Precision Medicine at the Dana-Farber Cancer Institute (DFCI).

He’s shown the power of partnering with patients via social media to speed research, with over 3,000 men and women joining the Metastatic Breast Cancer Project that launched in October 2015.

At the 2016 San Antonio Breast Cancer Symposium, Dr Wagle kindly spoke to BSB about the genomics research that he and colleagues are undertaking, and what this may mean for how metastatic breast cancer is treated:

  • What if you could help accelerate clinical trial enrollment via a network of educated and empowered patients?
  • What if you could access real world data to help learn about exceptional responders?

For those of you in Pharmaland, here’s one approach that should captivate the imagination of what’s possible.

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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 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!

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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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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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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There was a time when it seemed that all the good news emerging in cancer research was on breast cancer, that is clearly no longer true as other tumour types have seen some leaps and bounds with different modalities, including areas previously thought to be a graveyard for big Pharma, such as metastatic melanoma, for example.

new-dawn-houses-of-parliament

New Dawn at the Houses of Parliament

That said, after the excellent developments in hormone-sensitive disease and the identification of the HER2 oncogene, we now have CDK4/6 as a validated target in metastatic breast cancer.

Pfizer’s palbociclib (Ibrance) lead the way, with two approvals in previously untreated and relapsed ER+ HER2- advanced breast cancer. Two other companies in this field are Novartis with ribociclib and Lilly with abemaciclib. Data is being presented on all three therapies at ESMO this year.

In addition, there are some other abstracts of note that are well worth discussing.

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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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Today the immunotherapy and related data flooding out of the annual meeting of the San Antonio Breast Cancer Symposium (SABCS) is pretty exciting!

Data was presented on a number of drugs including pembrolizumab, avelumab and atezolizumab, which put together with some recent publications, highlights some potentially exciting opportunities in this fast moving space.

Here, we explore the potential for checkpoint therapy combinations in TNBC, HER2 and even the ER+ subsets.  There’s a lot of new findings to take in and contemplate here.

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