BOLERO-2 clinical trial of Everolimus in Advanced Breast Cancer

Posted on December 18, 2011 by Daedalus

SABCS 2011 San Antonio river walk by night 300x225 BOLERO 2 clinical trial of Everolimus in Advanced Breast Cancer Updated 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

Posted on December 10, 2011 by Daedalus

Deserted 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 #SABCS This 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

Posted on November 22, 2011 by Daedalus

San Francisco Transamerica Pyramid © Pieter Droppert 225x300 Insights from AACR Molecular Targets Meeting There 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

Posted on November 11, 2011 by Daedalus

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.

There 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.

PARP inhibition in Prostate Cancer

Posted on November 9, 2011 by Daedalus

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.

Sally 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.

PI3-Kinase pathway molecular targets

Posted on November 1, 2011 by Daedalus

The phosophoinositide-3-kinase (PI3K) pathway is a hot area in cancer new product development and is currently attracting a lot of interest in drug development.

Infinity Pharmaceuticals yesterday announced they would begin two Phase 1 trials of their small molecule (IPI-145), previously licensed from Intellikine, that inhibits PI3K delta and PI3K gamma.

A review by Sally Church of the top posts of the past year on Pharma Strategy Blog, showed that the most popular post was, you guessed it on:

PI3K: A hot topic in cancer research

Amongst the 640,000 reads of Pharma Strategy Blog this past year and a choice of over 900 posts, that is certainly quite an achievement. Incidentally, No 9 in the list of top 10 posts for the year, was Sally’s Update on PI3K from ASCO.

The PI3-kinase or PI3K pathway is one of Sally’s favorites, and as she notes it “has been shown to play a major role in proliferation and survival in a wide variety of human cancers, thus making it a potential target for therapeutic intervention.”

In addition to Infinity, an number of biotech and pharma companies are actively involved in clinical research that targets this pathway.

New data and further insights are expected at the forthcoming AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics in San Francisco.

AACR-NCI-EORTC Molecular Targets Meeting San Francisco

Posted on October 14, 2011 by Daedalus

The favorite scientific meeting of Sally Church, PhD is the American Association for Cancer Research AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics international conference that alternates each year between Europe and the United States.

This year it is being held in San Francisco from November 12-16, 2011, and already AACR has announced that a lot of new data will be presented on early stage new products in development.

On Pharma Strategy Blog, Sally notes the “luminaries” in personalized medicine that she is looking forward to hearing from in San Francisco.

Pieter Droppert on Biotech Strategy Blog also mentions the Molecular Targets conference and his interest in the plenary session chaired by Frank McCormick on “rational cancer drug development for targeted drugs.”

The potential for academia to facilitate combination trials with drugs from different companies was highlighted in Sally Church’s recent video interview with Gordon B Mills, MD PhD from UT MD Anderson Cancer Center.

If you have plans to be in San Francisco for the Molecular Targets conference do let us know. In addition to hearing about great science – networking and meeting people is one of the big reasons to attend.

Understanding the Pharma Biotech Competitive Landscape

Posted on October 3, 2011 by Daedalus

One of the pharma marketing strategy consulting services that we offer clients is a competitive landscape, market opportunity report.

These custom reports analyze a pathway, disease, tumor type or competitive set, and can include a thorough analysis of clinical data, biomarkers, epidemiology, market size and competitor activity. All our work comes with actionable insights and strategic recommendations.

Once our clients understand the competitive landscape, and the market opportunity for their product we often generate a path to market strategy.

One of the ways our consultants keep abreast of current pharma/biotech industry news is through writing about science and clinical data.

Following the recent 2011 European Multidisciplinary Cancer Congress (EMCC 2011), the joint meeting of ESMO, ECCO and ESTRO, Sally Church wrote an in-depth analysis of the phase II data for T-DM1 (trastuzumab emtansine) in first line metastatic breast cancer. You can read more on Pharma Strategy Blog.

Meanwhile on Biotech Strategy Blog, Pieter Droppert interviewed Dr Chris Parker about the phase III, ALSYMPCA trial results for radium-223 (Alpharadin) in advanced prostate cancer.

This radiopharmaceutical provides new treatment options for a neglected group of men who are unable to take chemotherapy. You can read more on Biotech Strategy Blog, and also watch the video interview below:

Alpharadin may change standard of care for prostate cancer patients with bone mets

Posted on September 29, 2011 by Daedalus

We recently attended the 2011 European Multidisciplinary Cancer Congress in Stockholm. Paradigm shifting data in breast cancer and advanced prostate cancer were presented at what turned out to be an excellent meeting in a charming, if expensive, city.

Sally Church (@MaverickNY) live tweeted several sessions from the meeting and was name the “Top Twitter Influencer” for the #EMCC2011 hashtag. You can catch up with the tweets fron ECCO ESMO ESTRO 2011 on Pharma Strategy Blog.

Source: Fox epractice

Pieter Droppert (@3NT) has written several posts on biotech strategy blog about the exciting data for radium-223 (Alpharadin) in advanced prostate cancer that was presented in Stockholm.

He also produced a video of the media briefing by Dr Chris Parker from the Royal Marsden Hospital where the ALSYMPCA phase 3 trial results were reviewed. It is well worth watching!

Please contact us if you would like to learn more about the fast moving Prostate Cancer market and how pharma marketing strategy may be impacted by the new products in development such as radium-223 (Alpharadin), that is on fast track for FDA approval in 2012.

Icarus Consultants

Pharmaceutical, Biotechnology Marketing Strategy & New Product Development Consulting

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