Author Archives: Daedalus

ASH 2011 Hematology Annual Meeting

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ASH 2011 Seattle Genetics Adcetris MOA Balloons 300x225 ASH 2011 Hematology Annual MeetingThe 2011 American Society of Hematology (ASH) annual meeting recently took place in San Diego.

What was hot at ASH in 2011?

In her pre-conference post, Sally Church on Pharma Strategy Blog outlined what she thought would be hot news and interesting data at ASH in 2011.

Amongst the topics she selected were:

  • CML: updated phase II PACE trial results for ponatinib
  • Myelofibrosis: updated phase III data from COMFORT-1 trial of ruxolitinib
  • Myeloma: 5 year data from VISTA trial that compares the combination of Velcade, melphalan and prednisone (VMP) with melphalan and prednisone (MP) alone
  • Lymphoma: the CD20 antibody obinutuzumab (GA101).

Sally also mentioned in her pre-conference post a few other compounds likely to be interesting in lymphomas such as the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 (Pharmacyclics) and the aurora kinase A inhibitor, alisertib (Seattle Genetics).

What were your predictions pre-ASH 2011?

It’s not easy to analyze a conference program that contains over 4000+ posters and predict what is going to be a hot topic, and commit to this in public in advance!

To do so requires an understanding of new products in development, mechanisms of action, prior clinical trial results and the impact positive or negative data may have on the standard of care.

If you went to ASH 2011 – how do you think Sally’s predictions stacked up?  Sally will be writing her own retrospective assessment in due course.

Although the San Diego weather was much wetter and cooler than expected, there was a lot of interesting data presented at ASH this year that more than made up for it.

Review #ASH11 Twitter Coverage

If you want to read what others thought was hot during the meeting, the #ASH11 tweets have been aggregated on Pharma Strategy Blog.

Impressive results for pertuzumab in CLEOPATRA breast cancer trial

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SABCS 2011 Jose Baselga Interview 300x225 Impressive results for pertuzumab in CLEOPATRA breast cancer trialAt the recent San Antonio Breast Cancer Symposium (SABCS), the clinical evaluation of pertuzumab and trastuzumab (CLEOPATRA) clinical trial results were presented by Dr José Baselga (Massachusetts General Hospital).

This study combined two anti human epidermal growth factor receptor 2 (HER2) monoclonal antibodies, trastuzumab and pertuzumab with docetaxel.

Results showed a median progression-free survival of 18.5 months in the pertuzumab plus trastuzumab plus docetaxel group as compared to 12.4 months in the control group that received placebo plus trastuzumab plus docetaxel.

In other words the addition of pertuzumab improved PFS by 6.1 months.  As Sally Church writing on Pharma Strategy Blog noted in her second update from SABCS, this is “another stunning six month leap in survival.”

The two monoclonal antibodies have different mechanisms of action and as Sally discusses in her post,

“the idea behind combining pertuzumab and trastuzumab upfront is to enable a more comprehensive shutdown of the HER2 pathway and delay the resistance setting in.”

You can read more on Pharma Strategy Blog. There was a lot of new data presented at the San Antonio Breast Cancer Symposium this year, and seeing the improvement in patient survival from BOLERO-2 and CLEOPATRA is what all those involved in the industry live for.

Sally poignantly describes this in her summary of SABCS:

“This year’s San Antonio Breast Cancer Symposium was very uplifting and one of the more exciting meetings of the last five years.”

Please contact us If you are interested in learning more about the breast cancer market and the impact new products in development such as the antibody drug conjugate T-DM1 and HDAC inhibitor, entinostat may have.

BOLERO-2 clinical trial of Everolimus in Advanced Breast Cancer

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SABCS 2011 San Antonio river walk by night 300x225 BOLERO 2 clinical trial of Everolimus in Advanced Breast CancerUpdated results from the BOLERO-2 (breast cancer trials of oral everolimus) were presented at the recent San Antonio Breast Cancer Symposium (SABCS).

José Baselga had previously presented the impressive results at ECCO/ESMO 2011 in Stockholm.

As Sally Church noted on Pharma Strategy Blog in her second update on “what’s hot at SABCS”:

“The trial data presented by Dr Gabriel Hortobagyi (MDACC) confirmed that the responses continue to be durable, with an improvement in PFS with the combination arm now up to 11.0 months, up from 10.6 months at ECCO. The results for the exemestane control arm remained at 4.1 months.”

The extra 6.9 months of survival benefit shown with exemestane plus the mTOR inhibitor everolimus is good news for advanced breast cancer patients.

One of the problems associated with aromatase inhibitor (AI) therapy in breast cancer is that patients develop resistance over time.  As Sally notes,

“The rationale behind this trial is that mTOR is a known cause of resistance to AI therapy, so the combination targets both the estrogen receptor and mTOR adaptive resistance pathway.”

You can read more on Pharma Strategy Blog about the BOLERO-2 trial presented at the San Antonio Breast Cancer Symposium and why this was a rationally designed study based on solid science.

SABCS San Antonio Breast Cancer Symposium Conference coverage #SABCS

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River Walk San Antonio SABCS 300x225 SABCS San Antonio Breast Cancer Symposium Conference coverage #SABCSDeserted River Walk due to San Antonio cold weather

If you are interested in news from the San Antonio Breast Cancer Symposium (SABCS) then Sally Church, PhD has a number of reports on Pharma Strategy Blog that are worth reading.

SABCS Video Preview

In her preview of the SABCS meeting (that you can also watch below), Sally reviews some of the BOLERO-2, CLEOPATRA and NEOSPHERE clinical trials, and what impact positive data may have on breast cancer patients. It is well worth watching.

SABCS Twitter Coverage

Although there is no wifi in the meeting rooms at SABCS, a few scientists, patients advocates and physicians are tweeting from the meeting including @drsteventucker and @teamoncology. You can easily follow the twitter conversation and check-out what’s been said through the #SABCS aggregator on Pharma Strategy Blog. As Sally would say, “check it out!”

As an example of how effective social media can be to share information, Pieter Droppert (@3NT) used storify to share some of the insights posted on twitter during the SABCS plenary lecture he attended on potential of macrophages as breast cancer drug development targets.

Breast Cancer and the Environment

Pieter also commented on the recent Institute of Medicine (IOM) report on “Breast Cancer and the Environment” which was somewhat disappointing to those hoping that it would highlight causal links.

Hot news at SABCS 

The Alamo San Antonio Texas 300x225 SABCS San Antonio Breast Cancer Symposium Conference coverage #SABCSThis year the San Antonio Breast Cancer Symposium had a lot of exciting new data. Two papers on the BOLERO-2 and CLEOPATRA trial data was published during the meeting.

Some of the interesting early data presented at the meeting included work on Notch inhibition to reduce aromatase inhibitor resistance, HER2 mutants and targeting HER3. You can read more updates from Sally Church on Pharma Strategy Blog.

Overall, this was one of the most interesting SABCS meetings of recent years with a good balance of science and clinical data.

Hopefully next year, there will be more discussants to put the data in context, as this would have made it an even better meeting.

Insights from AACR Molecular Targets Meeting

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San Francisco Transamerica Pyramid © Pieter Droppert 225x300 Insights from AACR Molecular Targets MeetingThere was a lot of interesting science at the recent AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics international conference in San Francisco.

In particular, the poster sessions offered the opportunity to discuss pre-clinical and early drug development work, and share insights into pathways and mechanisms of action. If you are in new product development, it’s a key meeting to attend.

What was the news at AACR molecular targets?

Sally Church on Pharma Strategy Blog aggregated the live tweets from the joint AACR-NCI-EORTC meeting, although the absence of wifi in the plenary sessions meant that there were fewer tweets than might have been expected.

Sally has written about some of the data presented on breast cancer at the meeting. In her insightful post she reviews the Syndax data for entinostat in second-line ER/PR+ breast cancer, and also asks whether ALK is a new target in inflammatory breast cancer (IBC)?

From what was heard at the meeting, there will be a lot of new breast cancer data at the forthcoming San Antonio Breast Cancer Symposium (SABCS) that Sally will also be attending.

More insights from AACR molecular targets will be available on Pharma Strategy Blog in the next few days.

Meanwhile on Biotech Strategy Blog, Pieter Droppert has written about some of the sessions he attended in San Francisco on:

Next year’s 2012 molecular targets meeting will be in Dublin, good news for all those who like Guinness!

Opportunities and Challenges with Cancer Immunotherapy

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At Icarus Consultants, we help pharmaceutical and biotechnology companies bring new products to market.

When we look at the market opportunity for a new product, it’s not enough to have a great product, key to success is getting paid for it.  Pricing and reimbursement are important in the commercial strategy!

Is it better to obtain the highest price for a new targeted therapy or alternatively have a lower price and obtain more market share? From a marketing strategy perspective, there is sometimes a case to be made for a lower price, but it’s a hard sell to convince senior management they are not leaving money on the table.

As to cancer immunotherapy, Dendreon with sipuleucel-T have shown that it can offer a survival benefits to some cancer patients. Other vaccines and immunotherapies are in development.

However, as Pieter Droppert points out in an insightful post on Biotech Strategy blog about a pilot study for PANVAC (Bavarian Nordic, CV-301), there remain a number of challenges that still have to be overcome.  These include:

  • How do we identify upfront which patients will respond to the vaccine?
  • How do we evaluate how well patients are doing without clinically validated surrogate markers to aid in assessment?

You can read more on Biotech Strategy Blog.  

AACR Molecular Targets Immunotherapy Plenary 300x185 Opportunities and Challenges with Cancer ImmunotherapyThere is a plenary session on cancer immunotherapy at the AACR-NCI-EORTC Cancer Molecular Targets & Therapeutics conference that starts in San Francisco tomorrow.

We look forward to obtaining further insights on the opportunities and challenges with cancer immunotherapy at this meeting.

Neuroendocrine Cancer Awareness Day

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Neuroendocrine Cancer Awareness Day Banner Neuroendocrine Cancer Awareness DayNovember 10, 2011 is the second worldwide neuroendocrine (NET) cancer awareness day. Pancreatic NET is what Steve Jobs sadly succumbed to.

In recognition of NET Cancer Day, Sally Church has written an insightful post on Pharma Strategy Blog about pancreatic neuroendocrine tumors and new treatment options. It is well worth reading!

Sally highlights two new therapies for pNET approved by the FDA this year:

  • everolimus (Afinitor) from Novartis that targets mTOR, downstream of the PI3K/AKT pathway
  • sunitinib (Sutent) from Pfizer, a multikinase inhibitor

Both showed a benefit over placebo with an increase in progression free survival (PFS). They do, however, have some challenges associated with their side effects.

Sally concludes that “in the future, we may well see sequencing studies emerge as well as other targeted therapies to prolong outcomes for patients with this rare disease.”

We hope that the Neuroendocrine Cancer Awareness day achieves its goal of raising awareness about this disease. You can read more on Pharma Strategy Blog.

Macrophage Cell Surface Protein S100A10 may be new target

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Sally Church, PhD on Pharma Strategy Blog has written about research on macrophage cell surface protein S100A10 and the role this plays in cancer metastasis and tumor growth.

As Sally notes, “macrophages are critical in driving tumour growth, invasion and metastasis.  Macrophages are like the Pacmen of cells…”  What a great visual metaphor!

Recently published research now shows that the macrophage cell surface protein, S100A10 plays an important role in how macrophages move to the site of tumor growth, a process that is key to tumor development and angiogenesis.

Is S100A10 a potential druggable target? You will have to read Sally’s insightful blog post to learn more.

PARP inhibition in Prostate Cancer

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The Society for Translational Oncology (STO) recently held a prostate cancer symposium in Belfast.

In a post on Biotech Strategy Blog, Pieter Droppert reviews the STO video discussion on “Prostate Cancer: Progress & Promise”

One of the key insights is that targeting ERG signaling may be key to treating prostate cancer, and that ERG becomes a druggable target by inhibiting PARP.

AACR Advances in Prostate Cancer Meeting 2012 PARP inhibition in Prostate CancerSally Church has written about the work of Arul Chinnaiyan’s lab on TMPRSS2:ERG and how this may be a more useful marker than PSA in prostate cancer.

You can read more on Pharma Strategy Blog about whether personalized therapy for prostate cancer is possible?

Sally will be attending the American Association for Cancer Research (AACR) special conference on “Advances in Prostate Cancer Research” in Orlando from February 6-9, 2012.

Co-chaired by Arul Chinnaiyan and Charles Sawyers, the meeting features plenary sessions on genomic and molecular profiling, prognostic signatures, androgen receptor signaling, drug development, ETS gene fusions, prostate cancer initiation and progression, and imaging.

If you have an interest in prostate cancer drug development and translational research this meeting looks well worth attending.

MDV3100 in Advanced Prostate Cancer

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The fast moving prostate cancer market took another leap forward last week with the announcement of positive phase III data for Medivation’s MDV3100.

As reported by Sally Church on Pharma Strategy Blog, Medivation announced that the interim analysis of the AFFIRM trial showed a 4.8 month increase in overall survival (OS) compared to placebo.

Although this is only interim and not final data, Sally observed:

“the 4.8 month improvement in OS in post-chemo setting is superior to that previously seen reported for abiraterone (Zytiga), which had a 3.9 month advantage over placebo.”

Pieter Droppert on Biotech Strategy Blog noted, MDV3100 and Zytiga have completely different mechanisms of action in advanced prostate cancer.

MDV3100 is an androgen receptor blocker, while Zytiga is an androgen biosynthesis inhibitor. This distinction is key.  Zytiga inhibits the CYP17 enzyzme complex required for androgen biosynthesis. However, a consequence of CYP17 inhibition is an increase in mineralocorticoid levels, which can lead to hypokalemia, hypertension, fluid retention.

The result is that Zytiga requires coadministration of a corticosteroid (prednisone) to reduce the incidence and severity of potential mineralocorticoid adverse reactions.

MDV3100 does not require the administration of a steroid, which is a big advantage to patients.  Instead it blocks the androgen receptor (AR) that is highly expressed on prostate cancer cells.

EMCC 2011 Sternberg Challenges to Developing New Advanced Prostate Cancer Drugs 1024x768 MDV3100 in Advanced Prostate CancerCora Sternberg presents Prostate Cancer Educational Symposia at EMCC 2011 in Stockholm

There are a lot of new products in the pipeline for prostate cancer including TAK-700, Cabozantinib (XL184), radium-223 chloride (Alpharadin), BPX-101, Prostvac-VF, ipilumumab, Custirsen (OGX-011), dasatinib (Sprycel), lenalidomide (Revlimid) and ARN-509 to name a few.

The prostate cancer market is forecast to grow from $1B to $5B by 2015 as new products are approved and new treatment options become available. This is good news for advanced prostate cancer patients.