At ASCO 2013, chronic lymphocytic leukemia (CLL), was probably one of the hottest topics at the conference after the anti PD-1/PD-L1 monoclonal antibodies.
CLL is a disease of the elderly, with an average age in the late 60′s to early 70′s range. For years, the mainstay of treatment has been chemo-immunotherapy with or without rituximab. People living with this indolent disease are prone to infections due to the immunosuppression that occurs over time. Fatigue and bulky adenopathy are also common as the disease progresses.
Over the last year or two, we’ve begun to see some exciting new possibilities emerge, with a number of new agents being evaluated in early phase clinical trials that target CD20, as well as the BTK and BCL2 pathways.
With several interesting new agents coming through the pipeline, Sally Church, PhD discussed the latest developments in CLL with Dr Susan O’Brien from MD Anderson. Recorded at ASCO 2013, the interview is part of the “Making a Difference” series published on Pharma Strategy Blog,
In her video interview, Dr O’Brien discusses several new agents – the first two already have Breakthrough therapy designation from the FDA:
- Obinutuzumab (GA101) – Roche/Genentech
- Ibrutinib – Pharmacyclics/J&J
- Idelalisib (CAL-101) – Gilead
- IPI-145 (INK128) – Infinity
- ABT-199 – AbbVie/Roche
You can read more about CLL on Pharma Strategy Blog, and in addition on Biotech Strategy Blog there is a pre-ASCO piece on the “CLL Runners and Riders in Race to Market.” For those interested in learning more about the CLL market, a report will be available over the summer.
Do contact us if you would like to learn more about our pharma thought leader market research services.
Sally Church, PhD has just published her annual pre-ASCO video, in which she discusses what’s hot in oncology new products at the 2013 ASCO annual meeting (ASCO 2013) that takes place in Chicago from May 31 to June 4, 2013.
The video is free via sign-up on Pharma Strategy Reports. Here’s the link to access Sally’s ASCO 2013 video preview.
If you have plans to be in Chicago later this week, then Sally highlights many of the noteworthy oral presentations and posters. Topics covered include developments in: PD-1/PD-L1 immunotherapy, CLL, Breast, Lung and Pancreatic Cancer.
Some of the new drugs in development mentioned include nivolumab, lambrolizumab, ibrutinib, LDK378 and obinutuzumab, all of which received FDA Breakthrough Therapy Designation earlier this year.
The annual meeting of the American Society of Clinical Oncology (twitter hashtag #ASCO13) is fast approaching. Later this week over 30,000 attendees will head to Chicago to hear the latest data on new cancer drugs and the results of clinical trials.
The expected highlight of the ASCO 2013 meeting will be data on PD-1 and PD-L1 immunotherapies: nivolumab (BMS), MPDL3280A (Roche) and lambrolizumab (Merck).
As Sally Church, PhD notes in her ASCO 2013 PD-1 PD-L1 highlights post on Pharma Strategy Blog when considering these new immunotherapies, important questions need to be answered:
- How much of a prolonged effect with PD-1/PD-L1 immunotherapies have over 5 years?
- What will be their effect on subsequent therapies?
- Will they boost or hinder sequencing and in which tumour types?
- Is there a biomarker of response?
- Is a diagnostic necessary?
Sally says “it continues to be an exciting area of oncology” and she’s “really looking to the presentations on PD-1/PD-L1.” We expect this to be the data of the meeting.
Another hot topic with a lot happening at ASCO 2013 is Chronic Lymphocytic Leukemia (CLL). Earlier this year the FDA granted it’s new Breakthrough designation to two drugs in development with CLL indications: ibrutinib from Pharmacyclics and obinutuzumab (GA101) from Roche/Genentech.
Other CLL new drugs with data at ASCO 2013 include idelalisib (GS-1101) from Gilead, IPI-145 from Infinity and ABT-199 being developed by Abbvie & Genentech. A cloud hangs over ABT-199 after the death of 2 CLL patients due to tumor lysis syndrome and this is likely to be a topic of discussion at ASCO. You can read more about the companies in the race to market in CLL on Biotech Strategy Blog.
Finally, you can now watch Sally Church’s video preview of what’s hot at ASCO 2013, it’s available for free, but you do have to sign-up on Pharma Strategy Reports to obtain the access link and password. Check it out!
The 2013 annual meeting of the American Society of Clinical Oncology (ASCO) is fast approaching, and for many in cancer drug development, it is one of the landmarks of the year.
This year, there’s a lot of interesting data on PD-1 and cancer immunotherapy, something we picked up on before the annual meeting last year. Sally Church, PhD is in the process of finalizing her pre-ASCO video and it will be available soon.
For a meeting that is typically orientated around solid tumors, there is a lot of data at the meeting on Chronic Lymphocytic Leukemia (CLL).
The CLL landscape is set to change, with new treatment options on the horizon. Ibrutinib received FDA Breakthrough designation earlier this year in three different indications, and we will be writing more about this market in a forthcoming Pharma Strategy Report.
For those clients and potential clients interested in learning more about our capabilities or discussing our services, we will be in Chicago for ASCO – please do contact us if you would like to meet up.
Pharma Strategy Report on Chimeric Antigen Receptor Technology CART available to download
May 21st, 2013
Daedalus
To celebrate the launch of Pharma Strategy Reports, we are offering a complimentary executive summary on Chimeric Antigen Receptor Technology (CART), written by Sally Church, PhD.
You can obtain your complimentary copy of this report on the Pharma Strategy Reports website. You will gain insights into:
- The challenges associated with immunotherapy and stimulating the immune system
- How are next generation immunotherapies making waves in cancer research?
- How recent papers in NEJM and Science & Translational Medicine have described this novel approach and what the preliminary data shows
- Some of the potential challenges or hurdles for registration of CTL019, the CART therapy being developed by Novartis.
CART is emerging as potential new exciting leukemia treatment – impressive results have been reported in a small cohort of adults with CLL and children with ALL who received the Novartis CTL019 therapy.
We expect there will be more data available at the 2013 annual meeting of the American Society of Hematology (ASH) later this year in New Orleans.
If you have an interest in understanding the potential of CART technology, then please sign up at Pharma Strategy Reports to download a complimentary executive summary. You will also be the first to know about future reports when they are published, such as what the new FDA Breakthrough designation means?
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.
At the recent American Society of Clinical Oncology Genitourinary cancers symposium in Orlando (ASCO GU), Sally Church, PhD interviewed Professor Bertrand Tombal about some of the latest clinical research in prostate cancer.
Professor Tombal is a leading urologist from Belgium who we always enjoy listening to at major international scientific meetings.
He invests a lot of time in giving educational presentations that are thought provoking and strategic.
You can read Sally’s interview: “Making a difference in Advanced Prostate Cancer – an interview with Bertrand Tombal” on Pharma Strategy Blog.
In the interview, Professor Tombal says what prostate cancer clinical trial he would do if you gave him a million dollars. We are not going to give the game away by telling you the answer, only to say it’s a combination trial that has a sound scientific rationale.
Check out Sally’s excellent series of interviews on people who are “Making a difference to the lives of cancer patients” if you have not already done so.
Celgene Corporation’s nab-paclitaxel (Abraxane) will be a new treatment for advanced pancreatic cancer. That was the news from the 2013 American Society of Clinical Oncology Gastrointestinal Cancers symposium (ASCO GI) that took place in San Francisco last month.
At the 2012 European Society of Medical Oncology (ESMO) meeting in Vienna, Sally Church, PhD noted on Pharma Strategy Blog that pancreatic cancer experts such as Margaret Tempero, MD were excited about the prospect of nab-paclitaxel in pancreatic cancer
The data presented at ASCO GI showed that for patients with metastatic adenocarcinoma of the pancreas, the addition of nab-paclitaxel to the chemotherapy gemcitabine led to an increase in median overall survival of 1.8 months compared to receiving gemcitabine alone (8.5 months versus 6.7 months, Hazard Ratio: 0.72, P=0.000015). While this may seem a small amount of time, there are few effective treatments for advanced pancreatic cancer.
By showing a significant increase in overall survival, Abraxane met the primary endpoint of the phase 3 MPACT clinical trial, and is likely to be approved by the FDA in the future.
Abraxane will provide a new treatment option in pancreatic cancer
The Abraxane data presented at ASCO GI was good, but it was not great. Sally Church interviewed Dr Hedy Lee Kindler, Associate Professor of Medicine at the University of Chicago about the significance of the data.
In her “Making a difference in Pancreatic Cancer Interview“, Dr Kindler says that for most of her patients she would still use FOLFIRINOX. This is a chemotherapy combination (5-fluorouracil, irinotecan, and oxaliplatin) that has side effects that need to be carefully managed.
It is only suitable for those patients who are well enough to take it, but offers a superior survival advantage in advanced pancreatic cancer. Data from the PRODIGE 4/ACCORD 11 study presented at the 2010 meeting of the American Society of Clinical Oncology (ASCO) showed the median overall survival time for patients receiving the FOLFIRINOX regimen to be 11.1 months.
Where we expect Abraxane to receive most pancreatic cancer use in the United States is from community oncologists who don’t wish to manage the side effects associated with FOLFIRINOX
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If you would like to learn more about the pancreatic cancer market and evolving treatment landscape, we will be publishing an in-depth report in the next few weeks.
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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.
We are delighted to announce the public launch of our annual “New Products MBA” program that involves custom monthly case studies and 1:1 coaching. Previously by private request only, this program is designed for senior executives with responsibility for new product development or those involved with strategic decision making in this area.
How does the coaching program work?
This is an individual program and lasts for one year during which 10 monthly case studies are undertaken on topics selected by the participant. These could be on a tumor type, pathway, indication or topic related to drug development e.g. the science and commercial challenges around chimeric antigen receptors. Case study topics are typically focused around the sponsoring company portfolio to enable learnings to be applied.
Each case study includes a 10-15 page written paper with background, analysis, insights and key strategic questions. Additional material in the form of scientific papers to read and videos to watch is also provided. The commitment required is equivalent to undertaking an Executive MBA.
Following review of the case study and accompanying material, a 1 to 1.5 hour 1:1 coaching session takes place by telephone with Sally Church, PhD in which key learnings are discussed.
Importantly, the program does not discuss confidential or proprietary information, it is focused on helping participants ask the right questions, not making a key decision for them.
Why is a new products coaching program necessary?
In recent years, oncology has become a fast changing environment where it is increasingly important to be able to see the scientific connections between pathways and tumor 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 do participants gain from this program?
The result of this coaching program will be an increased scientific understanding that enhances the ability to ask the right strategic questions of New Product Development and Brand Marketing teams and enable more in-depth strategic collaboration at the both the senior and middle management level.
What level of staff is this program aimed at?
This program was originally developed for a board level senior executive at a global pharmaceutical company. Based on its success we are making it publicly available in 2013 to a limited number of participants. We anticipate that it would benefit those at the Senior Director to Executive VP level who are involved with a range of oncology new products.
How much does this coaching program cost?
The program is comparable in cost to attending an Executive MBA, please contact us if you would like to learn more.