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Overcoming Resistance will drive the Oncology Landscape

January 31st, 2014


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


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


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!

Oncology New Product Executive Coaching

January 13th, 2014


In response to numerous client requests, one of the services we now offer is 1:1 executive coaching on Oncology New Product Development.

The aim of this program is to facilitate a greater understanding of emerging cancer targets through a series of custom case studies and 1:1 coaching sessions with Sally Church, PhD. 

The case studies are customized to the products, background and interests of the person being coached, making the program directly actionable in terms of its value to a company.

Why is coaching in oncology new products worth thinking about?

As Sally notes:

“Oncology is a complex field and is a fast changing environment where it is increasingly important to be able to see the scientific connections between pathways and tumour types, understand the emerging impact of new competitors with novel mechanisms of action, as well as biomarkers and companion diagnostics, and be aware of the evolving landscape for next generation immunotherapies.”

What we have seen is that if you’re working in a company it’s all too easy to get focused on a niche area, whether it be a product, tumor type or in the case of senior management, day-to-day operational decision making.  Being able to see the wood from the trees is becoming harder.

Feedback on this program is that the increased understanding it generates greatly enhances the ability to ask the right strategic questions of New Product Development and Brand Marketing teams.  It also enables more in-depth strategic collaboration and engagement, at both the senior and middle management levels.

In terms of work, it is not an easy ride, by any means.

It’s like doing an executive MBA in Oncology New Product Development, with regular case studies, scientific papers to read and 1:1 tutorials.  Due to the custom nature of the program, enrolment is limited.

If you are in oncology marketing, new product development or a business development professional that wants to enhance your strategic decision making skills do contact us for more information about this service.

2014 Cancer Conference Calendar

January 2nd, 2014


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!

What was hot at World Conference on Lung Cancer?

October 30th, 2013


Sydney Opera House 300x180 What was hot at World Conference on Lung Cancer?The 15th World Conference on Lung Cancer is drawing to a close in Sydney, Australia. By all accounts it’s been a successful meeting with several thousand delegates from all over the world.

We were not able to make it to Sydney, so have been following the meeting remotely. For us the Fall conference circuit this year has been ECCO in Amsterdam, AACR-NCI-EORTC Molecular Targets in Boston and we’ll next be at annual meeting of the American Society of Hematology in New Orleans.

At World Lung, AstraZeneca and Clovis Oncology presented new clinical data for their anti-EGF compounds against the T790M mutation in patients refractory to at least one prior EGFR therapy. This is a hot topic and potential good news for patients given their are no effective therapies on the market that target this mutation.

At the recent ECCO meeting in Amsterdam, AstraZeneca came out of left field to stun the audience with some exciting late-breaking data on AZD9291. By the time we reached Molecular Targets in Boston, they had ramped up the phase 1 trial from 1 site in Manchester to 28 around the world!

In Sydney, Malcolm Ranson from the Christie Hospital provided an update today on progress with AZD9291, while Jean-Charles Soria (Gustave Roussy) presented the Clovis CO-1686 data on Monday, including early results from the new formulation.

You can read more on Biotech Strategy Blog about what is one of the most promising drugs in the AstraZeneca pipeline.

AACR Molecular Targets Meeting in Boston

October 15th, 2013


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.

RAS mutations lead to worse outcomes in Colorectal Cancer

September 19th, 2013


Sally Church, PhD has published an insightful post on Pharma Strategy Blog that provides an update on KRAS and NRAS mutations in colorectal cancer (CRC).

The blog post discusses in detail a recent paper by Douillard et al, published in the New England of Journal Medicine (NEJM) that shows a clear benefit of adding anti-EGFR monoclonal antibody panitumumab (Vectibix) to standard chemotherapy in patients without RAS mutations.

Dr Douillard concludes that better selection of patients in 1st line treatment of metastatic colorectal cancer based on mutational status will lead to better outcomes. Lung cancer specialists routinely use mutational analysis to make treatment decisions, so this conclusion is perhaps not surprising, and only shows that CRC treatment has lagged behind.  It remains a disease where more effective treatment options are needed.

Do read Sally’s Pharma Strategy blog post (open access) if you’d like to learn more about how mutational analysis impacts anti-EGFR therapy in CRC.

ECCO ESMO 2013 European Cancer Congress in Amsterdam

September 18th, 2013


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


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.