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Posts tagged ‘Pharma CI’

Overcoming Resistance will drive the Oncology Landscape

January 31st, 2014

Daedalus

One of the recurring themes across multiple tumor types is the fact that cancer is smart and develops resistance to new drugs.

A visual metaphor used for this is traffic in mid-town Manhattan – if you block a cross-street, the traffic will stop for a while then slowly pick-up again as they find alternative routes.

Cancers not only adapt by finding alternative routes known as escape mechanisms, but they can mutate in the process into forms of cancer that no longer respond to existing treatment.

We have seen this in CML and NSCLC with the development of acquired resistance to treatment through T315I and T790M mutations, respectively.

In melanoma we’ve seen dramatic responses with BRAF inhibitors in patients with BRAFV600E- mutant melanoma, only for most patients to relapse due to acquired resistance and clonal evolution.  New treatments may need to consider not only different targets, but also sequencing, logical combinations and intermittent dosing strategies as described in the latest post on Pharma Strategy Blog on RAF resistance in metastatic melanoma.

In prostate cancer we see cross-resistance between enzalutamide and abiraterone, with the result that each drug is less effective when it follows the other.

You can’t assume that even though a drug has a different mechanism of action it will work: you have to look at the treatment landscape and how sequencing and resistance mechanisms may impact effectiveness.  A key question is how durable is the response to a new drug?

At ASCO 2013, Dr Charles Sawyers, in his Science of Oncology Award lecture noted that drug resistance is universal and that we need to define mechanisms of resistance.

Key to overcoming resistance are drug combinations – can we get to combination therapy faster is one of the key questions he raised, given that pharma often prefer single agent trials to make registration easier, especially if they only have one side of the coin in their pipeline.

Combinations are the future, not only in oncology, but also immunotherapy.  In her recent ASCO GI 2014 keynote lecture, Elizabeth Jaffee described the scientific rational for the combination of immune checkpoint inhibitors with vaccines.

Large pharmaceutical companies that have a pipeline of drugs that can be combined have a huge potential competitive advantage compared to small biotechnology companies.

Science is driving combination therapies to overcome resistance and increase effectiveness.  That is the future oncology landscape that anyone bringing new products to market needs to be aware of.

AstraZeneca AZD9291 & Clovis CO-1686 race to market in NSCLC

January 24th, 2014

Daedalus

The pharma competitive landscape is a dynamic one, which is good news for marketing strategy consultants – there’s always the need for an update on competitor activity and insights into how new clinical data may impact the market opportunity for cancer new products.

A modern David versus Goliath story in cancer drug development is unfolding as Clovis Oncology race to market against AstraZeneca; both companies have drugs in early clinical development that appear effective against T790M mutated lung cancer, for which there is currently no approved treatment.

We’ve been following the story from ASCO last year where Clovis presented a poster showing initial responses with CO-1686 to ECCO in Amsterdam where AstraZeneca gave an oral presentation on initial data on their phase 1 trial of AZD9291.

The story continued around the globe at AACR-NCI-EORTC Molecular Targets meeting in Boston then the World Conference on Lung Cancer (WCLC) in Sydney.

There were more insights on CO-1686 and AZD9291 at the recent JP Morgan Healthcare conference in San Francisco.

Despite the jump in Clovis’s share price, we think that AstraZeneca is still ahead, largely due to the fact that Clovis have had to reformulate CO-1686 and only had data for 3 patients with the new formulation at the World Lung meeting in Sydney.

We think Clovis have some catching up to do and need to present more data on its safety and efficacy. This is expected at the European Lung Cancer Conference in Geneva later this quarter.

AstraZeneca, meanwhile, will be presenting the results of their phase 1/2 trial at the ASCO annual meeting.  We would be surprised if this wasn’t an oral presentation, given the impressive initial data seen so far.

What’s more, by then the company will have patients who have been on drug for over a year, so we will have some sense of the durability of response. This is critical.

Cancer drug development is not conducted in isolation, and having an accurate picture of the competitive landscape is key if you want to create an effective positioning and messaging strategy.

We’ll be following the data on CO-1686 and AZD9291 and European Lung and ASCO.

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 AstraZeneca AZD9291 & Clovis CO 1686 race to market in NSCLC

2014 is the year of Immuno-Oncology

January 17th, 2014

Daedalus

One of the hot topic of conversation amongst the VCs at the JP Morgan Healthcare conference in San Francisco this past week was the field of immuno-oncology.

As AstraZeneca CEO Pascal Soriot noted in his JPM meeting presentation, ASCO 2013 was a major tipping point in immunotherapy and the future of cancer treatment.

We have already seen significant excitement in anti-PD1/PD-L1 drugs and their early promise in melanoma, renal and lung cancers.  As Soriot noted though, the future of immunotherapy is most likely in combination with other drugs.

Pharma companies with a broad pipeline of drugs suitable for evaluating combinations will be well positioned to take advantage of this paradigm shift in the treatment of cancer.

Taking a more strategic view, however, the question is how will immuno-oncology change the treatment landscape on a broader scale?  It is possible that many drugs that are currently in front-line use may be relegated to second or third line use if immuno-oncology combinations become the preferred initial treatment option.

One big question many are asking is how durable are the responses with the new immunotherapies, whether they be checkpoint inhibitors, immune stimulants or even chimeric antigen receptor (CAR) T cell therapies?

We have seen the development of resistance in oral TKIs that showed dramatic initial responses e.g. vemurafenib in melanoma, so will patients see a wearing off effect from immunotherapies, and if so, how will the resistance manifest itself? What new strategies will be important to consider going forward?

By using drug combinations, the hope is that you can achieve greater therapeutic index and close off the escape route of resistance, leading to a longer more durable response.   Companies in this space, including Roche, BMS, Merck and AstraZeneca are beginning to explore the opportunities for novel combinations, as this latest example from Merck shows:

Clinical Trials.Gov MK 3475 Lung Cancer Combo Trial 1024x613 2014 is the year of Immuno OncologyThere’s a lot we currently don’t know, but it looks as though this field is set to get much more exciting as companies explore new frontiers rather than sit still.

We’ll soon be publishing a short report on how the strategic landscape for oncology new product development is already changing as a result of the latest developments in immuno-oncology.

We expect to hear more on where the field is going at the forthcoming annual meeting of the American Association for Cancer Research (AACR) in San Diego.

In the meantime you can read more about the latest developments in immuno-oncology on Biotech Strategy Blog. Exciting times!

2014 Cancer Conference Calendar

January 2nd, 2014

Daedalus

Miami Beach 300x157 2014 Cancer Conference CalendarHappy New Year! As the cold weather hits the Northeast of the United States, it’s a good time to be in Florida.

For those on the cancer conference circuit, 2014 is the year of the west coast swing, with 3 major meetings in San Francisco and two in San Diego.

We’ve already made travel plans for the AACR annual meeting in San Diego, a notoriously expensive destination for airfares if you have to fly at the last minute.

There are a lot of cancer conferences each year but the key ones we plan to attend in person or write about on Biotech Strategy Blog and Pharma Strategy Blog include:

Jan 6-9 AACR-IASLC Joint Conference on the Molecular Origins of Lung Cancer, San Diego

Jan 16-18, Gastrointestinal Cancers Symposium (ASCO GI), San Francisco

Jan 30 – Feb 1 Genitourinary Cancers Symposium (ASCO GU)

Apr 5 -9  American Association for Cancer Research (AACR) 2014 annual meeting, San Diego

May 30 – Jun 3  American Society for Clinical Oncology (ASCO) 2014 annual meeting, Chicago

Sep 26 -30 European Society for Medical Oncology (ESMO) 2014 Congress, Madrid

Given the emerging importance of immunotherapy, SITC is a conference we have not been to before but plan to attend in 2014:

Nov 6-9 Society for Immunotherapy of Cancer (SITC) 2014 annual meeting, National Harbor, Maryland

Nov 18 – 21 EORTC-NCI-AACR Molecular Targets & Cancer Therapeutics, Barcelona

Dec 6 -9 American Society of Hematology (ASH14) 2014 annual meeting, San Francisco

Dec 9 -13 San Antonio Breast Cancer Symposium (SABCS) 2014

If you have a need for conference coverage or a custom in-depth landscape report on a particular therapeutic area or drug development target that includes data from several meetings, do contact us. We hope to see you at a cancer conference in 2014!

AACR Molecular Targets Meeting in Boston

October 15th, 2013

Daedalus

Boston Back Bay Prudential Center 169x300 AACR Molecular Targets Meeting in BostonThe annual Molecular Targets and Cancer Therapeutics meeting returns to Boston later this week and from the program and abstracts we’ve reviewed it looks like it will be an exciting meeting that will offer insights into many new cancer drugs in development.

Sally Church, PhD describes it as her favourite cancer meeting of the year. It’s a must attend for anyone in oncology new product development.

Jointly organized by AACR-EORTC-NCI, like the Ryder Cup it alternates between America and Europe. According to an AACR press release:

“The meeting, focusing on cancer drug development, draws nearly 3,000 attendees and gathers academics, scientists, and representatives from the pharmaceutical industry to discuss the effects new discoveries in cancer therapeutics and target selection have in molecular biology.”

Some of the new early stage compounds we are looking forward to hearing more about at Molecular Targets (Twitter #targets13) include AZD9291, PF-06463922, CRLX101, BMN 673, ABT-199.

You can read more coverage of the meeting on Biotech Strategy Blog.

ECCO ESMO 2013 European Cancer Congress in Amsterdam

September 18th, 2013

Daedalus

ECCO 2013 King Willem Alexander Opening Ceremony ECCO ESMO 2013 European Cancer Congress in AmsterdamNext week sees the start of the 2013 European Cancer Congress in Amsterdam.

ECCO have announced that King Willem-Alexander of the Netherlands will attend the opening ceremony, which is impressive.

Now that most of the meeting abstracts are available online we are starting to focus on what data may be hot at the meeting.

On Pharma Strategy Blog Sally Church, PhD has published her ECCO 2013 preview of late-breaking abstracts and those on PI3-kinase.

In addition to updates on PD-1 and PD-L1 data presented at ASCO, those that have attracted her attention include:

  • T-DM1 for HER-2+ metastatic breast cancer
  • Exploratory biomarker observations from the BOLERO-3 trial
  • FLT1 gene variation in NSCLC
  • Long-term survival data for ipilimumab in unresectable melanoma.

The PI3K-AKT-mTOR pathway is dysregulated in 80% cancers and Sally says it’s one of her favorite pathways. Ph1/2 data will be presented on GDC-0032, a next generation PI3K inhibitor.

Preliminary data showing early promise for GDC-0032 in breast cancer was presented at the 2013 AACR annual meeting.

You can read more about what may be interesting at the 2013 European Cancer Congress on Biotech Strategy Blog. Check it out! If you have plans to be in Amsterdam we hope to see you there.

 

 

Obtain Insights from Cancer Conferences

September 17th, 2013

Daedalus

Today, Biotech Strategy Blog launched a paywall where insights from cancer conferences will be available to subscribers who pay a fee for access. It’s the first in a series of online digital and print products that we will be launching in coming months.

Biotech Strategy Blog Paywall Obtain Insights from Cancer ConferencesThe aim in setting up a paywall is to offer added value to a select group of readers. It’s no longer sustainable to generate quality content for free. Many online media outlets have already come to the same conclusion.

In the next three months, premium content subscribers on Biotech Strategy Blog will gain access to exclusive coverage from the European Cancer Congress in Amsterdam, AACR Molecular Targets Meeting in Boston and ASH annual meeting in New Orleans. We will also be sharing insights from a series of interviews on the FDA Breakthrough Therapy Designation.

We hope that the financial support of blog readers will allow coverage of more cancer meetings in 2014. It’s an exciting time to be at the vanguard of online media, and many are watching our new business model with baited breath as to whether they should move in this direction too…we expect they will join us before too long, it’s a matter of economics.

 

The challenge of Tumor Lysis Syndrome in Hematology New Product Development

February 20th, 2013

Daedalus

Tumor Lysis Syndrome (TLS) has been in the news recently as a result of two patient deaths in a chronic lymphocytic leukemia (CLL) clinical trial with AbbVie’s ABT-199, a novel BCL-2 inhibitor in early stages of development.

What is TLS and why is this important in cancer research was subsequently analyzed by Icarus Consultants hematology industry expert, Sally Church, PhD on Pharma Strategy Blog.

Sally notes in her post, “we don’t yet know whether the effect in ABT-199 is a dose-schedule issue or a compound structure issue (especially given the reformulation from the original navitoclax issue).

It’s a major setback to AbbVie ($ABBV) when the company was poised to start a phase 3 clinical trial with ABT-199 in CLL.

AbbVie will have to convince doctors that careful dose scheduling can solve the problem of a drug that may be too potent for the body to handle.  Further deaths due to TLS could easily stop the development of this compound.

The setback to ABT-199 is, however, good news for ibrutinib that along with ABT-199 is in a race to market in CLL.

On February 12, 2013, ibrutinib received “breakthrough designation” from the FDA for the treatment of mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia.

Breakthrough designation means that a drug can be approved on the basis of early clinical data.  Depending on when filing takes place, FDA approval of ibrutinib in MCL could be forthcoming later this year.

We expect to be producing a report on the CLL new products in development soon. This will cover some of the challenges and issues companies are facing.  If you haven’t already done so, please sign up below if you would like to receive news alerts and be the first to know when reports are available.

 






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 The challenge of Tumor Lysis Syndrome in Hematology New Product Development

Seek Insights not Data Dumps

January 28th, 2013

Daedalus

Making sense of data is what we do. We live in a world where, thanks to the internet, the sheer volume of available data is increasing at an enormous rate.

Too often we see staff at client companies focus their energy on gathering data as cheaply as possible, instead of asking or seeking to understand what does all the data mean from a competitive stand point?

Data is now commoditized. Anyone can gain access to past ASCO Virtual Meetings, for example, and watch a rerun of conference presentations. While obtaining data is relatively easy, insights are a lot more expensive and difficult to generate.

Why?

Well, they require the application of knowledge, deep understanding and expertise of the topic to analyze, conceptualize and visualize data, and then extrapolate what it means to a company or product.

Here’s a fun video that shows how a picture tells a thousand words. Professor Hans Rosling, in this excerpt from a BBC documentary, shows the public health history of 200 countries in 4 minutes…

Turning data into a powerful illustration requires the expenditure of intellectual effort.

Making sense of data is what we do at Icarus Consultants.

The Challenges of Multiple Myeloma Market Research

November 29th, 2012

Daedalus

ASH LOGO

Multiple Myeloma (MM) is forecast to be a hot topic at the forthcoming annual meeting of the American Society of Hematology (ASH) that starts in Atlanta next week.

There are four “Super Friday” satellite symposia and over 700+ MM  abstracts that will be presented in multiple oral and poster sessions. If you add in the recent FDA approval for carfilzomib (Kyprolis) and the anticipation that pomalidomide (Actimid) will be approved soon, there’s a lot going on.

We specialize in Thought Leader or Key Opinion Leader (KOL) market research. Often projects are a hybrid where we discuss high-level strategic issues with KOLs and ask community hematology-oncologists or medical oncologists more practice-focused questions.

Based on our experience, multiple myeloma is a challenging topic for pharma market research:

  • Treatment regimens can be complex, even some community medical oncologists have told us they are challenged by them.
  • Treatment decisions are multifactorial and individualized, so it’s often hard for community based physicians to generalize.
  • High prescribing community physicians may be in small towns not near a market research facility, requiring telephone interviews.
  • Thought leaders are busy people – you need to focus on a few key questions you want them to answer.
  • Access to top-tier thought leaders is difficult, they often will only talk to people they know or have met at medical or scientific meetings.

If you have plans to be in Atlanta for ASH, do contact us. We’d welcome the opportunity to meet up and tell you more about what we do.