Dr. Cooperberg on Prostate Cancer Stage Migration

[Anonymous]

Excellent video on trend to teating to find mets earlier and comparatively lower cost of provenge vs. long-term administration of new hormonal therapies:

http://www.onclive.com/onclive-tv/Dr-Cooperberg-on-Prostate-Cancer-Stage-Migration

Matthew Cooperberg, MD, MPH

Published Online: Tuesday, March 12, 2013

Matthew Cooperberg, MD, MPH, Assistant Professor of Urology; Epidemiology & Biostatistics, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, discusses the imminent stage migration that is likely to occur as new therapies become available expressly for metastatic prostate cancer.

The boundary between M0 (no metastasis) and M1 (metastatic) prostate cancer is arbitrary and depends heavily on the methods used to detect metastasis. In fact, Cooperberg stresses, most patients with M0 prostate cancer likely have microscopic metastasis that cannot be detected by standard bone scans.

These stages have remained unchanged to date because therapeutic options were limited. However, recent advances have brought an abundance of effective treatments into this space, providing incentive to pursue more advanced diagnostic approaches, such as fluorine-based PET scans.

This stage migration will not be without consequences, Cooperberg notes. While the agent sipuleucel-T (Provenge) has a fixed cost, other treatments can be given for an open-ended timeframe. Beginning these therapies earlier, and ultimately providing them for a longer period of time, may dramatically impact costs.

 

[Anonymous]

Provenge is ideal for attacking microscopic metastasis. This is exactly where the treatment will show its true benefit and muscle - earlier stage disease.

 

[Anonymous]

This all great and warms the cockles of my heart but we aren't indicated for M0 disease, genius. Good luck getting results on a trial in M0. This can be categorized as fluff.

 

[Anonymous]

Now you know more about prostate cancer than Dr. Cooperberg? MO patients are NOW being identified as M1 because of new screening technology. He specificcaly mentions that this applies to provenge. Too difficult for you to understand?

 

[Anonymous]

Provenge is ideal for attacking microscopic metastasis. This is exactly where the treatment will show its true benefit and muscle - earlier stage disease.

All Provenge studies evaluating efficacy have been done in patients with metastatic disease. Unless Dendreon has plans to initiate a study in the M0 population (which is highly unlikely...and we all know why), there is little evidence that it will work in micro-metastatic disease.

 

[Anonymous]

You still do not understand. M0 patients are now being identified as M1 because of improved screening technology. This increases the number of provenge eligible patients.

 

[Anonymous]

You still do not understand. M0 patients are now being identified as M1 because of improved screening technology. This increases the number of provenge eligible patients.

I understand perfectly. The efficacy studies were done in patients using the technology that was available at that time. The new technology might detect smaller disease but there is no clinical evidence to show that provenge improves survival in those patients. This is "hypothesis generating" which is fine. The solution...do a small study. Why doesn't Dendreon do a study? It's an easy solution.

 

[Anonymous]

They are doing such a study. It is called the P-11 clinical trial. Obviously you are completely unaware of scientific developments at the company.

 

[Anonymous]

They are doing such a study. It is called the P-11 clinical trial. Obviously you are completely unaware of scientific developments at the company.

The P-11 study enrolled patients from July 2001 to July 2005 with 208 patients enrolled. The results of that study (reported at ASCO 2007) showed that there was no difference in the time to biochemical failure in the two treatment arms but there was a slight but not statistically significant difference in the PSADT. There is a follow-up study looking at patients who participated in the P-11 study but the endpoints of that study are immune responses generated by sipuleucel-T (as usual) and safety. The study will include only 90 patients with an expected completion in 2017. You're right, I am completely unaware of scientific developments at Dendreon.

 

[Anonymous]

You are correct you are completely unaware of scientific developments at Dendreon. P-11 is an ongoing study where patients are still being followed for the clinical secondary endpoints of distant failure and overall survival. These are the most important data that the study will provide and the study has not yet been completed. This study might wind up being a huge financial benefit to Dendreon.

See bottom of page 5 of 10-k filing.

http://investor.dendreon.com/secfiling.cfm?filingID=1193125-13-74139&CIK=1107332

The trial you are mentioning is the follow-on trial to P-11 (P-10-1) and these patients are also being tracked for survival.

Dendreon is also running several other label expansion trials. Any of these label expansion trials could quadruple the eligble patient population for provenge.

 

[Anonymous]

You are correct you are completely unaware of scientific developments at Dendreon. P-11 is an ongoing study where patients are still being followed for the clinical secondary endpoints of distant failure and overall survival. These are the most important data that the study will provide and the study has not yet been completed. This study might wind up being a huge financial benefit to Dendreon.

See bottom of page 5 of 10-k filing.

http://investor.dendreon.com/secfiling.cfm?filingID=1193125-13-74139&CIK=1107332

The trial you are mentioning is the follow-on trial to P-11 (P-10-1) and these patients are also being tracked for survival.

Dendreon is also running several other label expansion trials. Any of these label expansion trials could quadruple the eligble patient population for provenge.

The primary endpoint of P-11 was time to biochemical failure. The PSADT result was an interesting observation which warranted further evaluation. This trial is not powered to show a survival benefit but it might produce an observation that is hypothesis generating. I wish you the very best. I'm in this for the patients, not for the financial benefit of any company.

 

[Anonymous]

This is a board for SALES professionals, so I guess company financial benefit would be relevant.

http://clinicaltrials.gov/ct2/show/NCT00779402?term=NCT00779402&rank=1

"Subjects will continue to be observed until DF is confirmed by bone scan or compurvivuted tomography (CT) scan, or other imaging modalities as clinically indicated. After confirmed DF, subjects will be followed for safety and survival for the remainder of their lives. The total time on study for each subject is estimated to be approximately 10 to 13 years."

A survival benefit could lead to a compendium listing and thus would be covered by insurance. The trial was started in 2001, so a survival benefit could be reached soon.

Dendreon is not running all these potential label expansion trials for entertainment purposes. The goal is that the trials will lead to more patients receiving provenge.