Prostate Cancer Notes & Notable – New Claims Data!

Partnership with Health Market Science provides access to claims data for Prostate Cancer.

(For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Drug Market Info is pleased to announce a partnership with Health Market Science (HMS), a specialty healthcare data company. HMS uses proprietary technology to systematically collect, analyze and publish accurate and current information from the most comprehensive U.S. provider database and the largest practitioner-level medical claims database in the U.S. Only HMS can track activity at the ‘claims’ level.

Drug Market Info will now be including Health Market Science data as another analytical tool for assessing the oncology market in our new 2013 Prostate Cancer Market Info™ report.

Don DeStefano is Vice President of Life Science Sales at HMS and a longtime friend. His career spans more than 20 years in the healthcare industry encompassing leadership roles in Sales, Market Research, and Account Management. During this time, Don has partnered with numerous healthcare clients to successfully meet their data management and information needs. Don has this to say about the value of this comprehensive claims database.

Could you begin by telling us about HMS?

Health Market Science helps solve business challenges with healthcare provider information. HMS uses big data technology and domain expertise to build solutions that help our clients improve operational efficiencies and maximize market opportunities. These solutions are based on our proprietary data, which includes more than 6 million HCPs and 400,000+ unique healthcare organizations and their affiliations, as well as the largest medical claims database in the United States.

What does HMS offer that other databases or suppliers do not?

We offer our Provider MasterFile™, the most accurate and comprehensive source of provider reference data, and the vast coverage of our medical claims warehouse. Escalating regulations as well as fierce competition are driving the need for the more comprehensive market intelligence that HMS provides. Understanding where physicians spend most of their time can improve sales and marketing strategies for life sciences organizations. Our Provider Master File contains millions of data points on all U.S. healthcare practitioners including physicians, advanced nurse practitioners, dentists, veterinarians, and physician assistants. Attributes for each HCP include ranked demographic data as well as essential credential information. The integration of our Provider MasterFile with our vast PxDx® medical claims data warehouse drives improved assessment and quantification of market share and opportunities and takes organizational intelligence to the next level.

How can the HMS data be used with pharmaceutical audit data (Rx’s and sales) to better understand markets?

Many companies look at the prescription volume shipped to an account. HMS takes this one step further and combines that information with our medical claims data enabling us to identify the provider associated with each account and the corresponding volume of patients. This increased market visibility offers more insight than prescription data alone.

Drug Market Info is now including HMS “claims” level data in the new 2013 Prostate Cancer Market Info™ report. What perspective will HMS data provide that is missing now in understanding the prostate cancer market?

With HMS data, an enhanced quantitative perspective of the prostate cancer market provides another analytical view, especially since there is a lack of available prescription data due to the nature of therapy (injectables and infused drugs). HMS provided data to Drug Market info for the new 2013 Prostate Cancer Market Info™ report that shows which settings prostate cancer patients go to for treatment, as well as the volume of patients who had a PSA Test, and the reason for the PSA Test.

How can companies use HMS data to their best advantage?

The value of medical claims data is that it provides quantitative data for non-retail brands such as oncology and specialty drugs. Companies can use it to target high-value physicians and where they practice, determine market size, sales force sizing and alignment, and to segment practitioners for non-personal promotions.

Can you provide a couple of examples of how clients actually use your data?

Absolutely.

Example #1

A top medical device company was looking to maximize sales force efforts for a pain management device in order to meet revenue goals. They had been targeting and segmenting physicians using internal sales data and territory insight accumulated by a seasoned sales force.

HMS delivered precise physician and organization data including projected patient volumes and the corresponding decile ranks. This gave them the ability to:

• Sort by volume and hone in on the settings with higher sales potential, such as acute care hospitals and ambulatory surgery centers
• Understand which physicians had privileges at an acute care hospital, along with a breakdown of which specialties were performing the targeted procedure
• Understand which messages and tactics were needed based on the MD being targeted

As a result, the company learned who their physician targets were, the settings where they practice, and they were able to prioritize based on volume to more effectively deploy the sales resources against high-value targets.

Within 60 days, the company’s sales force:

• Generated a 278% return on investment (ROI)
• Generated an additional $500,000 in opportunities

Example #2

A biotech firm was looking to gain market share after the FDA withdrew indication approval for a well-known tumor-starving drug in the treatment of metastatic breast cancer (MBC). They needed to understand the indication-specific utilization of the competitive product in order to target the relevant physicians who had been using that product.

HMS provided the total volume of patients with a diagnosis of MBC at the physician level and the oncologist’s chemotherapy utilization at the product level – specifically the drug recently taken off label for the treatment of MBC patients. The biotech firm could now:

• Understand which oncologists were treating MBC patients with a specific drug/ treatment of interest
• Rank the oncologists by patient volume and product utilization
• Prioritize sales and marketing resource efforts
• Tailor the promotional message

In summary, Health Market Science and Drug Market Info are pleased to be partnering to provide an enhanced analytical view of the prostate cancer market.

Leading Researcher Expounds on Faster FDA Approvals – Notes & Notable on Oncology Drug Approvals

Drug Market Info presents Notes & Notable, an interview series with leading voices in the field. Today we present our interview about Oncology drugs with Dr. Christopher-Paul Milne, DVM, MPH, JD. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Dr. Milne is Director of Research at Tufts Center for the Study of Drug Development (TCSDD), Research Assistant Professor at Tufts University Medical School, a member of the Editorial Board of the Food & Drug Law Journal, and an Honorary Fellow at the University of Edinburgh. He joined TCSDD in 1998 to address legal and regulatory issues and current research interests include: tracking new regulatory and research initiatives such as regulatory science, comparative effectiveness research, translational medicine and personalized medicine.

Here is what Dr. Milne has to say about his study recently completed by the Tufts Center for the Study of Drug Development, “Oncology Drugs Get Faster Approvals than Non-Oncology Drugs in U.S., But the Opposite is True in the EU”:

Why is there a shorter approval time for oncology drugs in the U.S. versus the European Union?

There is a different philosophy at FDA. It embraced expedited review for cancer earlier than the European Marketing Authority (EMA) and is more comfortable and facile with it. FDA isn’t relying so much on predictivity of animal data but rather is focused on new, more flexible weighting of the evidence. This approach utilizes a target population medicine concept which favors benefit (efficacy) over potential risk. However, unknown levels of risk are still difficult to quantify pre-approval, because of the small number of patients tested pre-approval.

FDA and EMA appear to approach cancer differently. What is different about the EU review process?

Cancer is a complex disease, not only scientifically but also politically. Choices have to be made about how to address both aspects. The European environment for making decisions in both spheres adds an additional level of complexity.

Were you surprised from your research that oncology drug review times in the U.S. are 10 months shorter than other drugs?

Yes and no. We were not surprised that cancer was faster, but we were surprised that it was so much faster! We have recently done an analysis of FDA review divisions which confirmed what we already knew about cancer “exceptionalism”. The oncology review division has an edge over other divisions.

Since fast track and accelerated approval status do not seem to affect oncology drug approval time, how should companies view this?

Fast track and accelerated approval do help. Typically, the more special programs you can get your R&D project approved for, the more scientific interaction with the agency and prioritization it can benefit from – that’s what Fast Track provides. At the same time, Accelerated Approval, for example, allows FDA to more readily approve a drug on the basis of efficacy for surrogate endpoints that are just predictive (sometimes by a few years) of actual efficacy.

In the case of cancer, companies also have other factors working in their favor. On the payer side of the equation, payers see value in reimbursing medicines for cancer that are “conditionally” approved for what may not seem like dramatic outcomes in terms of cure or long extensions of survival time. This is not done in other therapeutic areas.

Total drug development time for oncology and non-oncology drugs decreased by half a year in the last decade. Can you elaborate on the process improvements that occurred?

In addition to the FDA’s approach on flexible weighting discussed in Question 1, I would also add that an organized and long-standing advocacy movement for cancer has helped. This has extended to addressing development problems such as patient recruitment.

In addition, there is an integral and balanced relationship between private and public sector resources that are devoted to this endeavor. The National Cancer Institute, academia and industry partner in so many ways and this makes the evidence compelling and more objectively framed when it comes time for FDA review. And last, strong cancer advocacy among a very active network of cancer medical specialists helps in this regard (for example with availability for Advisory Committee Meetings).

What do you think the FDA is doing right as far as reviewing and approving oncology drugs?

Obviously…just about everything. For some specifics, you could look at our recent paper on FDA review divisions (CP Milne and KI Kaitin. FDA Review Divisions: Performance Level and the Impact of Drug Sponsors Clinical Pharmacology & Therapeutics 2012; 91:393-404.).

What advice would you give to companies developing oncology drugs?

Look at the unmet medical needs that are developing in cancer. Forty percent of cancers are preventable, largely by vaccines that prevent the underlying infection, such as Hepatitis C in liver cancer or papilloma virus in cervical cancer. Yet of the 40 indications in the late-stage pipeline for cancer-preventing vaccines, only 10 are for diseases likely to have major health impacts in the emerging markets over the next 5-10 years.

The late-stage pipeline does not seem primed to meet the needs that will hit the practice environment in the next 5-10 years, let alone further down the road.

There are a number of products in the late-stage pipeline for the six major types of cancer. However, there are at least another six cancers that I have looked at with few and sometimes no late-stage products in the pipeline. These cancers will be among the top 3 cancers in the emerging and next wave markets by 2020 according to World Health Organization data.

There are also unmet medical needs in the mature market. Survivor syndromes, such as those in the evolving area of cardio-oncology, indicate that the occurrence of cardiac after-effects of surviving cancer treatment are increasingly recognized and require management. Also, breakthrough or hard-to-manage pain greatly affects quality of life in cancer patients who otherwise manage the cancer well.

On the down side, tumor heterogeneity and increasing competition in the targeted medicine market means developers will have to spend more just to keep pace with their current success. When you look at market projections for the next five years, cancer usually still comes out on top in the U.S. and world market for total market size in dollar volume. But cancer is often not even among the top 5 therapeutic areas in terms of compounded annual growth.

Prostate Cancer Notes and Notable – Dr. Judd W Moul: Part 2 – Sequencing and Prostate Cancer Treatment

Drug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today we present Part 2 of our interview with Judd W Moul, MD,  Director of the Duke Prostate Center, Professor of Surgery, Duke University School of Medicine and the James H. Semans, MD Professor of Surgery at the Duke Cancer Institute. (Click here for Part 1 of the interview, focusing on new prostate cancer drugs Zytiga and Xtandi.) Dr. Moul is an international authority on prostate cancer and outcomes/database research. His clinical interests include minimally invasive nerve-sparing radical prostatectomy, multidisciplinary management of prostate cancer, and clinical trials in prostate disease. He was director of the Center for Prostate Disease Research, a Congress-mandated research program of the Department of Defense. He received national acclaim for creating a prostate disease research database that houses information on more than 20,000 prostate cancer patients treated at nine collaborating institutions. In 2009, he was selected as a recipient of the “National Physician of the Year” award, presented by Castle Connolly, publisher of the America’s Top Doctors series.

Here are some Notes from Dr. Moul on “Sequencing” and treating prostate cancer:

How do you currently select which therapy to use for men with prostate cancer who are castrate-resistant, but not yet symptomatic for metastatic disease?

There is only one FDA-approved new agent for this population and it is Provenge® (sipuleucel-T) immunotherapy. Provenge is specifically approved for asymptomatic or minimally symptomatic metastatic CRPC. It is best used for men who have mets (metastases) but are not yet on narcotics for cancer-related pain and who have early CRPC. New data suggest it is best for men who have a lower PSA level, such as less than about 25 ng/ml. At the Duke Cancer Institute (DCI), we have used Provenge extensively and like to sequence it as the first novel treatment for CRPC before chemotherapy and early in the course of metastatic CRPC.

Zytiga® is now being reviewed as a treatment for prostate cancer in patients who have not received chemotherapy. The FDA should finish in mid-December. What are your thoughts – will it get approved? Does it improve survival?

I certainly do not want to speculate on FDA decisions. However, Zytiga is clearly very active in the setting of CRPC prior to docetaxel-based chemotherapy. The drug resulted in an improvement in progression-free survival and significant delay to chemotherapy compared to placebo. Survival was also improved, but just missed being statistically significant at the current analysis. With regard to survival, the current P-value for significance was just higher than the standard benchmark of P= 0.05. As more patients are followed for survival, this result may become statistically significant. However, with more novel agents being used in these patients, this may be part of the reason that the survival endpoint was not completely met.

From your experience, would most prostate cancer patients rather take Zytiga than go on chemotherapy?

I think the message to patients is that all of these new agents are important and I do not like to pit one drug against another. Some patients will prefer to start an oral therapy before further chemotherapy. However, currently Zytiga is only FDA approved for men who have progressed on docetaxel-based chemotherapy and some men may want to march on with further chemotherapy and would go on to Jevtana®. Other men may desire a break from chemotherapy and will prefer Zytiga before moving on to Jevtana. It is up to us as prostate cancer doctors to educate our patients about all the new options and to prepare and educate patients that they may need all these new drugs given in a sequential fashion.

What about Provenge, where do you think it fits?

As noted above, Provenge is a novel cellular immunotherapy custom-made for each patient and can be administered over about 4 weeks with three separate leukophoresis procedures followed several days later by re-infusion of activated product. In two separate phase III clinical trials, the survival benefit was 4.1 to 4.5 months compared to a placebo control group. However, two-thirds of the control patients received a frozen cellular immunotherapy similar to Provenge at the time they progressed on placebo. Recent secondary analyses have suggested a greater survival benefit for men who had lower PSA values (less than about 25 ng/ml) and perhaps that a comparison of Provenge to true placebo patients may result in a greater survival benefit than the reported survival benefit of 4.1 months. I think Provenge fits in the earliest phase of metastatic CRPC while patients have a robust immune system and it should be given ideally at least 3-6 months before the patient is expected to need chemotherapy or steroids.

With all of these new treatment options, how will doctors decide which drugs to use and where?

This is the key question to our field now that we have four new agents available in the last several years for use in advanced prostate cancer. If we follow the current (Sept 2012) FDA-approvals and use these drugs fully on label, then the sequence might look like this:

1. Provenge; 2. Docetaxel; 3. Zytiga or Jevtana or Xtandi® depending on the physician and patient preference. Also, denosumab (Xgeva®), a new RANK-Ligand inhibitor given at 120 mg subcutaneously every month, is also FDA-approved to prevent skeletal events in men with advanced prostate cancer. It can be used as soon as a man is diagnosed with bony-metastatic prostate cancer or can be reserved for those with CRPC at a similar time as the patient is eligible for Provenge.

There is a lot of talk about “sequencing.” What does it mean for prostate cancer treatment?

As noted in some of the earlier questions, it is using the new agents in the correct order for the individual patient. We are very excited that the “toolbox” has more tools to help us treat our patients with advanced prostate cancer. However, we are not certain which order to use all the new riches at our disposal.

What are your patients saying about all the new drugs? What is still needed?

My patients have renewed optimism about their prospects even when they develop metastatic prostate cancer. However, they are also concerned that the government via the US Preventative Services Task Force (USPSTF) has recommended that doctors stop using the PSA test to screen for prostate cancer. If we truly go back to the “Pre-PSA Era” we will go back to a time when 20-25% of men present initially with metastatic prostate cancer. Currently, in the PSA-Era this had fallen to only about 2%. We may see more patients who are candidates for these new agents because we are no longer picking up cancer early.

In my opinion, we still need to look for the disease earlier especially in younger men where a diagnosis of metastatic prostate cancer is still a death sentence despite all the new drugs. However, we do need to do a better job to fine tune testing in older men to avoid overtreatment. We also need better disease markers for early and advanced disease – PSA is good, but we need even better disease markers. We also need a better way to image inside the prostate so we can better define early stage tumors for individual patients.

Prostate Cancer Notes and Notable – Dr. Judd W Moul: Part 1 – A Leading Clinician’s View on Zytiga® and Xtandi®

Drug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is with Judd W Moul, MD,  Director of the Duke Prostate Center, Professor of Surgery, Duke University School of Medicine and the James H. Semans, MD Professor of Surgery at the Duke Cancer Institute. Dr. Moul is an international authority on prostate cancer and outcomes/database research. His clinical interests include minimally invasive nerve-sparing radical prostatectomy, multidisciplinary management of prostate cancer, and clinical trials in prostate disease. He was director of the Center for Prostate Disease Research, a Congress-mandated research program of the Department of Defense. He received national acclaim for creating a prostate disease research database that houses information on more than 20,000 prostate cancer patients treated at nine collaborating institutions. In 2009, he was selected as a recipient of the “National Physician of the Year” award, presented by Castle Connolly, publisher of the America’s Top Doctors series.

Here are some Notes from Dr. Moul on Xtandti® (Medivation), Zytiga® (Johnson & Johnson)  and treating prostate cancer:

What do you think about Xtandi, the new drug from Astellas/Medivation? Could you have predicted that it would be approved three months early?

We have been hearing about this new drug now for the past 2-3 years. We were first introduced to it as “MDV-3100” and more recently by its new generic name, “enzalutamide.” What is brand new for me is the catchy trade name of “Xtandi.” I am very excited about this new oral antiandrogen because of its triple mechanism of action against the androgen receptor and its impressive survival advantage over placebo in castrate-resistant prostate cancers (CRPC) that have progressed after chemotherapy. I was not really too surprised when it was approved early because it showed impressive survival gains with an excellent safety profile.

Where will Xtandi fit into the treatment regimen for Prostate Cancer?

Enzalutamide will initially be used in men who have castrate-resistant prostate cancer (CRPC) and who have progressed after docetaxel-based chemotherapy. In other words, these are men who have metastatic (spread) prostate cancer who have stopped responding to traditional hormonal medications- the LHRH agonists/antagonists and the traditional oral antiandrogens, and also after docetaxel-based chemotherapy. The most common clinical scenario will be those men who have a rising PSA level and or progression of their metastatic disease while being managed with traditional hormones, such as leuprolide acetate and docetaxel chemotherapy. At this point, the managing physician would continue the leuprolide-type LHRH agent but discontinue other cancer drugs, including the chemotherapy, and start the man on Xtandi.

What about Zytiga? Is it effective for patients where cancer has metastasized (with few or no symptoms) following androgen-deprivation therapy? Is this a difficult patient group to treat?

Zytiga, or abiraterone, is another novel hormonal medication that was FDA-approved in April 2011 for men with CRPC. It is also effective and showed a significant survival benefit in men who had stopped responding to docetaxel-based chemotherapy. We now have three FDA-approved new medications in the “Post-docetaxel space” in CRPC: cabazitaxel (Jevtana®); abiraterone (Zytiga) and now enzalutamide (Xtandi). Jevtana (25 mg M-squared IV given every three weeks with low-dose oral steroids) is a taxane systemic chemotherapy that was approved in June 2010 and was the first novel drug to show a survival benefit in post docetaxel CRPC. The median survival benefit was about 3 months and it received accelerated FDA approval due to it being the first agent to show improved survival in this group of patients.

Zytiga is an oral agent taken at a dose of 1000 mg daily (four 250 mg tablets taken once daily along with low-dose oral prednisone 5 mg twice daily). The biggest challenge now will be to learn how to properly sequence these three novel agents for maximal patient benefit. Furthermore, both Zytiga and Xtandi are both effective in men who are pre-chemotherapy CRPC and are both likely to be approved in the next year or so in the pre-chemo space. The clinical trials of all three of these agents were done independent of the other two so we still have to learn how to use these drugs together and in the best order for our patients.

What have you heard from patients about Zytiga? What about side effects or any other patient-related issues?

Zytiga is well-tolerated; however, does have to be given with low-dose prednisone. It may cause hypokalemia (low serum potassium levels) so doctors need to measure a serum potassium level before starting the drug and need to monitor levels periodically. It can also cause fluid retention and hypertension so oncologists and urologists need to be aware and monitor appropriately. In the post-docetaxel setting where it is currently FDA-approved, the low-dose steroids are not generally an issue and patients are being monitored by oncologists and their staff pretty often. However, when Zytiga becomes FDA-approved in the pre-chemotherapy setting where men are generally healthier and may not be monitored as often, doctors will need to be a little more vigilant with monitoring patients on Zytiga.

Also, in the pre-chemotherapy setting, patients are generally under the care of urologists and not oncologists. Among urologists, we are working hard to further train a subset of urologists to use these new agents who will be very comfortable managing men in this new era. As far as patients, what I have heard is that virtually all patients are excited about the new options where we have more to offer them and the prospects of making advanced prostate cancer more and more of a chronic disease.

With all of these new treatment options, how will doctors decide which drugs to use and where?

This is the key question to our field now that we have four new agents available in the last several years for use in advanced prostate cancer. If we follow the current (Sept 2012) FDA-approvals and use these drugs fully on label, then the sequence might look like this:

1. Provenge®; 2. Docetaxel; 3. Zytiga or Jevtana or Xtandi depending on the physician and patient preference. Also, denosumab (Xgeva®), a new RANK-Ligand inhibitor given at 120 mg subcutaneously every month, is also FDA-approved to prevent skeletal events in men with advanced prostate cancer. It can be used as soon as a man is diagnosed with bony-metastatic prostate cancer or can be reserved for those with CRPC at a similar time as the patient is eligible for Provenge.

Prostate Cancer Notes and Notable – Dr. Tomasz Beer, co-author of Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials

Drug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is again with Dr. Tomasz Beer, M.C., F.A.C.P.. (Click here for yesterdays interview focusing on Prostate Cancer) Dr. Beer is a medical oncologist who leads a research and clinical trial program at Oregon Health & Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer devoted a good portion of the past year to writing a book about cancer clinical trials together with Larry Axmaker, Ed.D, a cancer survivor and clinical trial participant. The book is entitled  Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials. Dr. Beer co-authored this book because he wanted to contribute to the fight against cancer. Here are his comments…

Please tell us a little about your new book and who should read it?

“Cancer Clinical Trials” is written for people living with cancer, their families and loved ones. We hope to make clinical trials and the experimental therapies they offer much less intimidating and by doing so, help people make the best decisions for their cancer care. We delve into all facets of clinical trials, from design and principles, to strategies for finding and choosing a trial to issues of insurance coverage and many other practical aspects.

We have found the book is also of interest to physicians in training, nurses, and other health professionals who interact with patients and need to know the fundamentals of experimental cancer therapy. It may also be of interest to pharmaceutical companies who want to understand how to approach clinical trial recruitment.

What prompted you to write this book?

For 15 years now, I have been deeply involved in clinical trials. I have talked to thousands of cancer patients about hundreds of clinical trials. Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients. The book was the only way to get this done.

What do you think is the most important message (or most unique point) in the book?

The book is meant to be an A to Z guide to clinical trials, from what they are, to how to decide if a clinical trial is right for one’s cancer care plan, to many practical aspects of

taking part in a clinical trial. There are many different messages I would want to highlight. If there is one, I would say that in cancer care, there is a need for improvement and advances throughout the continuum of cancer care.

Clinical trials are not just for folks who have no other options. Even when a well-established standard treatment is available, there is often room for improvement. Every person diagnosed with cancer should be knowledgeable about clinical trials so they can make truly informed decisions about their care.

What makes patients willing (or not) to participate in a clinical trial? Does the type of trial make a difference?

I think a trial needs to make sense for a particular situation. First and foremost, it has to be a well-designed trial that asks a sensible question. It has to offer a sensible alternative to the other options. There has to be some potential advantage, for example more effective therapy or less toxic therapy. What that translates into varies greatly by situation.

In prostate cancer, for example, there are situations where the disease is growing slowly and we would ordinarily just watch it. Very low risk interventions may be attractive here. There are also situations where the disease is very aggressive and other treatments aren’t working. More risk might be appropriate in that setting.

What do patients need to be aware of before they decide to enter a trial?

The single most important thing is to be knowledgeable about one’s disease and standard treatment options. Only then can one put a clinical trial option in perspective. We have a whole list of tips on our blog. I encourage readers to take a look at: http://www.cancer-clinical-trials.com/2012/04/practical-tips-on-choosing-clinical.html.

Would the book be beneficial for a company conducting clinical trials?

Absolutely. Participation in clinical trials remains disappointingly low. For companies working hard to move a drug forward, this results in far greater cost. From the time it takes to get a trial done, to the number of sites needed to complete a study, the low participation of people living with cancer is a major challenge to the pharmaceutical industry. We expect that the book will provide cancer patients the knowledge they need to confidently consider a clinical trial for their cancer care and therefore increase trial participation. We think every oncology office that conducts clinical trials should have this book available to their patients as a critical educational resource.

The book may also help with subject retention. Early drop out of research subjects is another challenge for clinical trials. When this happens for good reasons, such as dangerous side effects, that is unavoidable. We believe sometimes it also happens because patients don’t have enough knowledge about how to navigate the responsibilities of being a study participant. The book can help.

Is there anything that would help companies conducting clinical trials?

We think that making the book available at trial sites so that patients can approach their care decisions with strong knowledge about clinical trials will increase trial accrual. Folks already participating in a trial will also feel more secure in being a study subject armed with the knowledge the book provides. Our clinical trial system is incredibly inefficient and dismal participation of cancer patients in clinical trials is a key contributor. We are convinced that accessible knowledge about clinical trials will help substantially.

Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials by Tomasz M Beer, MD and Larry Axmaker, Ed.D
Pub. Date: April 2012/Price: $16.95
ISBN 13: 978-0-9823219-7-3/Trade Paperback: 192 pages

Where can Cancer Clinical Trials be purchased?

The easiest way is to go to Amazon.com and type in “cancer clinical trials” or “Tomasz Beer.” The book shows right up. You can also go to the book’s Amazon page. For bulk purchases, a discounted price may be available from our publisher. More information can be found on the authors’ blog and at the publisher’s website.

Prostate Cancer Notes and Notable – Dr. Tomasz Beer, Chair for Prostate Cancer Research Deputy Director, OHSU Knight Cancer Institute

Drug Market Info presents Prostate Cancer Notes & Notable, an interview series with leading voices in the fight to cure Prostate Cancer. (For more data on Prostate Cancer, see the Drug Market Info Prostate Cancer Fact Sheet)

Today’s interview is with Dr. Tomasz Beer, M.C., F.A.C.P.,  a medical oncologist who holds the Grover C. Bagby Endowed Chair for Prostate Cancer Research and leads a research and clinical trial program at Oregon Health and Science University Knight Cancer Institute, and who specializes in the treatment of prostate cancer. Dr. Beer has been in practice for 15 years and is the author of hundreds of medical publications. He recently co-authored a new book entitled Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials (which will be discussed in tomorrow’s blog post).  Here are his comments on treating prostate cancer:

How long have you been working with prostate cancer?

I have worked with prostate cancer for 15 years and have been actively involved in more than 100 clinical trials for prostate cancer.

What is the most difficult issue(s) for patients with regard to prostate cancer treatment and how does this get addressed?

I don’t think there is a simple answer to this question. For many men, it’s the decision about initial treatment following diagnosis. The choice between surgery, radiation, and observation is very challenging. In advanced disease, it’s often about managing the side effects of treatment to preserve quality of life.

The treatment armamentarium for prostate cancer has recently expanded significantly. How is this changing the actual treatment approach?

There are many more treatment options for advanced disease. When prostate cancer becomes resistant to standard hormonal therapy, we now have a number of life-extending options. That is brand new and very good news.

With all the changes, where do you see a drug like Provenge fitting into the treatment scheme?

Provenge offers a survival advantage for men with metastatic, castration-resistant prostate cancer that are free of symptoms or nearly free of symptoms. The sequence of treatments is in such rapid evolution, that we need to keep paying attention to this question. Because immuno-suppressing drugs may interfere with a response to Provenge, the timing of Provenge treatment needs to consider not only the patient’s condition but also other treatment before and after Provenge. Ideally, patients should not receive steroids or other immuno-suppressive drugs for 3 months before and after Provenge.

In your experience, what percentage of men with prostate cancer agree to enter a clinical trial and does this differ by disease stage? How does this compare to other types of cancer?

I work in a university setting, so the folks I meet may be more inclined to consider trials. In choosing us, they may have expressed an openness to clinical trials, so I don’t know if my experience reflects that of all. Having said that, in our practice more than half of our patients are open to clinical trials and around 25 to 30% end up participating. The level of interest is very high and I think that is true at all stages of the disease.

How do you feel about the proposed changes to the PSA screening recommendations and what do patients generally want to do about annual screenings?

I think men need to understand both the potential benefits and risks of early detection. I don’t think we should be discouraging screening. I think we should be discouraging screening without a balanced and thorough discussion. New data from additional follow-up of the European study are showing more favorable results than initially reported and I would think that the USPSTF should consider these new data and think about these tough issues some more.

What should new drug developers keep in mind as they develop new therapies for prostate cancer?

With so much progress over the last few years, it would be easy to think that prostate cancer is saturated with new drugs. This is not so. Men are still dying of the disease and we need to continue to strive to make progress until that changes. The field is more complicated and new drugs need to be quite a bit better than current drugs to compete, but the need remains.

And last, tell us a bit about your new book?

Co-authored with Larry Axmaker, a cancer survivor and clinical trial participant, the book, Cancer Clinical Trials: A Commonsense Guide to Experimental Cancer Therapies and Clinical Trials, is designed to demystify clinical trials for cancer patients and their families and loved ones. The book provides an easy to read and understandable, yet comprehensive guide to clinical trials and aims to help people develop a foundation of knowledge, make an informed and thoughtful decision about the role of clinical trials in their care, and navigate through the experience of being a participant. For more information, please visit the authors’ blog and to take a look at the book directly, please visit http://tinyurl.com/cancer-clinical-trials-book.

Prostate Cancer Fact Sheet

Looking for the facts about Prostate Cancer and the rapidly growing Prostate Cancer market? The following information comes from our Prostate Cancer Market Info™ report, which is now available for purchase and download on our website, Drug Market Info.

What is Prostate Cancer?

Prostate cancer (PC) is a common cancer in men and the second leading cancer-related killer behind lung cancer. It is a malignant adenocarcinoma that grows as small tumors throughout a man’s prostate gland. Some tumors are indolent and require no treatment, but others are aggressive and life-threatening. Currently, there is no way to tell tumor aggressiveness and no clear guidelines about how to manage the disease, despite the launch of several new treatment options.

Most of the time (80%+) prostate cancer is discovered before it has spread beyond the prostate gland. For this reason, five-year survival is nearly 100% and 10-year survival is 91%. If metastasis has occurred, survival is considerably lower (29% at five years). For those patients with recurrences and/or advanced disease, metastasis is usually to the bone, a development that compromises quality of life, increases treatment costs and negatively affects overall survival.

Prostate Cancer: Diagnosis

Prostate Cancer generally causes no symptoms. Since the 1990s, prostate specific antigen (PSA) screening has been used to determine if a man has PC. PSA is a protein produced by cancer cells – a rising PSA level is suggestive of cancer, although there are other causes for a rising PSA. Testing is once a year for all men over age 50 (this recommendation is being challenged and is likely to affect future screening). Biopsies, along with digital rectal exams and imaging, are used to confirm if a man with an elevated PSA has prostate cancer.

If biopsies are positive for cancer, aggressiveness is rated using a scale between 2 and 10 that assesses differentiation: well-differentiated cancer is usually not aggressive and gets a low score; poorly differentiated cancers are aggressive and get high scores. These numbers are known as the Gleason Score, and it is the best available measure of cancer aggressiveness. Treatment decisions are often based to a large extent on a patient’s Gleason Score.

Prostate Cancer: US Epidemiology

Prostate Cancer (PC) is the most common non-skin related cancer in men:

• 1 of every 6 men will develop it in their lifetime
• Over 2 million in the U.S. currently have PC
• Nearly a quarter of a million men will be newly diagnosed in 2012
• 34,000 men die annually of PC – 2nd leading cause of cancer-related deaths, after lung cancer

There are 3 known risk factors for PC:

1. Advancing age: PC is rare in men under age 50; common over age 80
2. Race: Black men have the highest incidence in the world; Asians the lowest
3. Family history: 1st degree relative doubles risk; 2+ relatives = nine-fold increase in risk

Mortality from PC has declined about 30% since 1992:

• “A man is more likely to die with prostate cancer than from it.”
• 80 is the median age of death from PC (close to average life expectancy)
• 12% percent of men die of PC after diagnosis

Prostate Cancer: Treatment

There is no universally recommended treatment for PC at any stage and many choices exist. Whether treatment should be delayed or begin immediately is controversial, especially in the earlier disease stages.

Treatment decisions depend on likelihood of disease progression and are predicated on the Gleason Score, metastasis, co-morbidities, a man’s overall health, and cancer stage at diagnosis, among other factors. If the disease is still confined to the prostate gland itself, common treatment options are:

• Radical prostatectomy
• Radiation therapy
• Brachytherapy
• Active surveillance (no treatment, but frequent ongoing monitoring with PSA levels and biopsies)

There is no clear proven benefit for any approach at this time, but regardless of option chosen, nearly 100% of patients are alive 5 years out. Men are monitored for a recurrence with PSA levels every 3-6 months.

For men in whom PC has spread or those with a recurrence, androgen depletion therapy with LHRH analogs is the standard approach. This works by depleting testosterone, which is necessary for prostate cancer growth. Over time, some men have tumors that become resistant to this approach (castrate-resistant), and require the addition of other therapies, which may include anti-androgens, immunotherapy like Provenge® (sipuleucel-T) or chemotherapy like Taxotere® (docetaxel). Many of these men do not have symptoms and have no evidence of metastasis. The length of time a man is in this castrate-resistant stage is highly variable, but once metastasis is seen (usually on a bone scan), symptoms appear. At this point, options include chemotherapy, radiation and bone-targeted therapies (which reduce bone pain and prevent fractures). Men at the later disease stages have recently begun to have more options with the approval of three new drugs: Zytiga®, Jevtana® and Xtandi®.

Some Interesting Facts about Prostate Cancer

• Radical prostatectomy is the most frequently chosen option as initial curative therapy for PC.
• Active surveillance (monitoring disease progression without concurrent treatment) is always an option for less aggressive cancers. Currently, fewer than 10% of men opt for this approach.
• Most men are NOT symptomatic until the last 6 mos. of their lives, which drives demand for drugs with minimal impact on quality of life.
• Unlike many other cancers, there is no interval (such as 5 years) beyond which the risk of PC recurrence is negligible, and thus, ongoing surveillance is required.

Prostate Cancer: Research

The intracellular and extracellular pathways involved with prostate tumor growth, metastasis and treatment resistance will probably require use of multiple drugs or drugs with multiple sites of activity. Since the discovery of Taxotere®, the first chemotherapy to show activity and improve overall survival against advanced prostate cancer, research in the disease has significantly expanded. Clinical trials for prostate cancer increased 30% in just two years – over 2,000 clinical trials are now in various stages with 350+ in Phase 3 and over 900 in Phase 2.

What do Patients say about Prostate Cancer?

Here are some comments from patients:

“The secret with PC is to keep it in the prostate. You may wait and see for 3 years and now it’s outside the prostate and there is less you can do, but you could have done something 3 years back.”

“When I first started on the shots (of LHRH) I got a little tired, got hot flashes and found out what menopause is like!”

“You have to find ways to get through it. I’m 75 years old, not 30. I have aches and pains, I’m not as strong as I used to be, I have to take naps in the afternoon. How much of this cancer-related? How much medication related? How much just age-related? I think you can attribute a lot to age.”

To learn more about the ‘Patients’ Perspective,’ Drug Market Info will gladly put you in touch with patients and clinicians who can share their experiences.

Every Prostate Cancer Market Info report you purchase generates a donation to ZERO — The Project to End Prostate Cancer.

ZERO — The Project to End Prostate Cancer is committed to creating Generation Zero: the first generation of men free from prostate cancer. Zero prostate cancer deaths. Zero prostate cancer cases. Zero tolerance for prostate cancer. To accomplish their goal, ZERO provides comprehensive treatment information to patients, education to those at risk and conducts free prostate cancer screening throughout the country.

Drug Market Info Launches New Prostate Cancer Market Info™

DRUG MARKET INFO LAUNCHES NEW PROSTATE CANCER MARKET INFO™  

 Comprehensive Presentation-ready Report on Prostate Cancer Covers All Treatment Options and Up-to-date Market Information with Patients’ Perspectives  

NORWELL, MA– March 27, 2012- Drug Market Info®, the only source for presentation-ready market reports with the Patient’s Perspective, announced today the launch of its newest research report – Prostate Cancer Market Info™. Prostate cancer is a common cancer found in men, and has the second leading cancer-related mortality rate behind lung cancer.  Prostate Cancer Market Info™ is a comprehensive look at the market, including current market data, diagnosis statistics, and treatment options, as well as patient estimates by disease stage.

Prostate Cancer is a malignant adenocarcinoma that grows as small tumors in different locations throughout a man’s prostate gland. Some tumors are indolent and require no treatment, but others are aggressive and life-threatening. Currently, there is no way to tell tumor aggressiveness and no clear guidelines about how to manage the disease, or which treatment option works best.  Recently, several new products for the later stages of Prostate Cancer have been launched and according to a recent Barron’s report, the metastatic prostate-cancer market could grow from approximately $1 billion to $8 billion by the end of the decade.

Prostate Cancer Market Info™ provides a comprehensive look at the market, covering epidemiology, patient estimates by disease stage, as well as unit and sales data trended for five years. As a presentation-ready report, Prostate Cancer Market Info™ is the only market analysis that contains over 100 customizable slides, 28 graphs and charts, with patient insights and perspectives woven throughout. As with all Drug Market Info reports, Prostate Cancer Market Info™ was reviewed by a leading clinician in the field to validate disease dynamics and therapeutic approaches.

“Prostate Cancer is a disease that significantly impacts men and their families with one out of every six developing the disease and over two million men in the U.S. currently living with it,” said Mary Beth Cicero, Principal of Drug Market Info. “This new report from Drug Market Info provides unique insights on the diagnosis and treatment of prostate cancer, especially since there are a variety of choices available to physicians and their patients. The Prostate Cancer Market Info™ report examines the current landscape of available treatments and pipeline products, but more importantly, spotlights how real patients weigh their treatment options and ultimately decide upon a regimen that works best for them.”

“We see over 1,000 newly diagnosed prostate cancer patients each year,” said Judd Moul, M.D., F.A.C.S. James H. Semans, MD, Professor of Surgery Director at Duke Cancer Institute. “Every man is different, so his cancer is different and his treatment choices will be, too. Therefore, it is important that a comprehensive array of treatments be available, as well as access to clinical trials and cutting-edge therapies. Drug Market Info’s comprehensive Prostate Cancer Market Info™ thoroughly covers the patients, treatments and what is in the pipeline, and is an important resource for companies looking to better understand this disease.”

Drug Market Info develops reports based on putting patients front and center. We are strong supporters of patient advocacy and our business model is built around donating a portion of our proceeds to the leading patient advocacy group in each therapeutic area we cover. Drug Market Info is extremely proud and privileged to be associated with ZERO — The Project to End Prostate Cancer. The organization is committed to creating Generation Zero: the first generation of men free from prostate cancer. Zero prostate cancer deaths. Zero prostate cancer cases. Zero tolerance for prostate cancer.  To accomplish their goal, ZERO provides comprehensive treatment information to patients, education to those at risk and conducts free prostate cancer screening throughout the country. To learn more about ZERO, visit http://zerocancer.org.

“This year alone, more than 241,000 men will be diagnosed with prostate cancer and more than 28,000 will die from the disease,” said Skip Lockwood, Chief Executive Officer of ZERO. “We are seeing the death rate decrease, but we must remain vigilant in the fight against this disease by increasing research funding, raising awareness and education, and testing men with risk factors. We are pleased to be associated with Drug Market Info for making available important data on the prostate cancer market, and for showing how the disease and treatment dramatically affects the lives of men.”

About Drug Market Info (http://www.drugmarketinfo.com/)

Have you ever just wanted to understand a disease – what it looks like, who gets it, what are the treatments, which products are used and how the market is valued? Drug Market Info was founded by experienced pharmaceutical professionals who recognized the need for current, ready-to-use market information that gets to the real core of understanding a therapeutic market. Drug Market Info reports are centered around the concept of the three P’s – Patients, Perspectives and Potential with a strong focus on patient and physician insights. Our reports provide clinically accurate, up-to-date information on treating diseases such as Psoriasis, Psoriatic Arthritis, Cystic Fibrosis and Prostate Cancer, as well as how these markets are defined, sized and valued. Unique from other industry reports on the market, Drug Market Info delivers information in a presentation-ready PowerPoint format at a reasonable price. In just minutes, you can download a customizable deck of slides covering everything you need to know about a therapeutic market and the opportunities it represents.  Most importantly, only Drug Market Info provides patients’ perspectives on the disease and their treatment experiences. The Company proudly collaborates with leading Patient Advocacy Groups so that every report purchased will benefit patients with the disease.

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