provenge

If anyone is interested, Dendreon kicked off its new Direct-to-Consumer (DTC) television advertising campaign this morning with early morning ads on Bloomberg TV and HLN (among other channels???). As well, it appears there was a coordinated print media blitz that accompanied the introduction of the new television ads.

Wow! Who do you rep for? JNJ or Medivation? LOL Let's look at the facts.

Dendreon sold their NJ facility for $43 million to Novartis, who immediately hired 100 of Dendreon's employees at the facility. Yes, sales appear stalled in the range $80-85 million, but still up from a year ago as the company expands and strengthens its field marketing organization, especially in urology. Price was a red herring, though yes, 'price density' (the fact the entire treatment occurred in one month) cause initial concerns with physicians. The fact is, reimbursement is under 30 days today (well under the 120 days providers extend on credit), with many providers receiving their money from CMS in 14 days. By the way, the price of Provenge is a little over $93,000, of which 6% goes to the physicians.

The cost of Zytiga is $5400 per month (plus prednisone + monthly blood tests), and pre-chemo (where Zytiga only has an NCCN 2A classification), the treatment during JNJ's Phase 3 trial--which did NOT show a statistical significant overall survival (OS)--was 14 months. No OS benefit was seen until the 18th month, 4 months after patients in the treatment arm came off Zytiga...at the point where 20% of the patients had died. And note, too, that because Zytiga is reimbursed as a pill on Medicare Part D, patients in the Donut Hole can get hit...hard. That's why, patients on Zytiga can end up with more co-pay than patients on Provenge. (Seventy-five percent of patients on Provenge have little or no co-pay.)

As for Xtandi, that costs $7,500 per months, and it, too, has an NCCN 2A rating in Provenge's space. So far, there are no data to support FDA approval in Provenge's space. It, too, is reimbursed as a pill.

Urologists are reluctant to prescribe off-label, so few will prescribe Zytiga and Xtandi for pre-chemo patients (except, perhaps, where the patients disease load is growing rapidly...there, Zytiga most likely will be prescribed).

Yes, with Provenge, the PSA is not lowered. But there are other ways to address this...for example, with Casodex.

'Relief' is most decidely NOT rare. (What color is the sky in your world?) Based on three Phase 3 clinical trials, the FDA approved Provenge because it demonstrated an median overall survival benefit of 4.1 months. When you remove the effects of patients crossing over from the placebo groups and being administered a frozen from of Provenge (Frovenge), the median overall survival benefit jumps to between 7.8 and 13.1 months. Post hoc studies show that if a patients PSA is 22.1 or less, administration of Provenge provides a median overall survival benefit of 13 months.

Aren't facts wonderful?

Truly a disinfectant for the FUD one runs into from time to time on the Internet, don't you think? (;>)

Sun

And here is a window on the new Provenge Web site, with our own Todd Seals' video:

http://www.provenge.com/video-treatment-stories.aspx#rollin3

I'm sure you remember Todd...he was the man who ran into roadblocks last spring when Kaiser refused to pay for his Provenge, citing the junk science from Huber et al. as the reason. Todd appealed immediately to the insurance commissioner from the State of Washington, who stepped in and whacked Kaiser. Todd was infused last May, and is living large!

Sun

Hey, gang...I just saw that I had the wrong URL to find Todd's two videos. Try this:

http://www.provenge.com/video-treatment-stories.aspx

Sun

Congrats, on the improvement in PSA doubling time.

Congratulation 49packard,
I just read your thread when trying post some new information about Provenge.
It is always gladness to read about good response on Provenge. Just read from Devasted1, who also receive Provenge:
"Grateful, because the cancer clinic told me that I am the only one still living that was diagnosed when I was with the high grade of cancer, and that we live in the times we do with so much advancement by heroic men and women that are researching new treatments and perfecting existing treatments. "

www.healingwell.com/community/default.aspx?f=35&m=2680094

From 6th Annual Interdisciplinary Prostate Cancer Congress March 16, 2013:

Dr. Petrylak on Sipuleucel-T Delaying First Opioid Use
Daniel P. Petrylak, MD
Published Online: Thursday, March 21, 2013
"Daniel P. Petrylak, MD, director, Prostate and Genitourinary Cancer Program, co-director, Signal Transduction Research Program, at the Smilow Cancer Center at Yale-New Haven, discusses the relationship between sipuleucel-T (Provenge) and time to first use of an opioid analgesic in patients with metastatic castration-resistant prostate cancer (mCRPC).

The patient discussion regarding treatment with sipuleucel-T can be challenging since clinical parameters outside of overall survival are largely unavailable, Petrylak notes. As a result, data on pain progression from three randomized trials that investigated sipuleucel-T in men with mCRPC were analyzed.

In general, the analysis found a trend toward a delay in pain progression in favor of treatment with sipuleucel-T. Additionally, Petrylak notes, a significant increase in the time to first use of an opioid analgesic was observed. Overall, this is a clinically meaningful difference; however, these findings may still need to be validated, Petrylak concludes. "

www.onclive.com/onclive-tv/Dr-Petrylak-on-Sipuleucel-T-Delaying-First-Opioid-Use


Dr. Dreicer on Combination Therapies in Prostate Cancer]
Robert Dreicer, MD, MS
Published Online: Wednesday, March 20, 2013

"Robert Dreicer, MD, MS, chairman of the Department of Solid Tumor Oncology at the Taussig Cancer Institute and professor of Medicine at the Cleveland Clinic in Ohio, describes potential combination therapies currently being considered as treatments for men with prostate cancer...

Dreicer notes that researchers are interested in the combination of AR antagonists with novel agents, such as sipuleucel-T (Provenge) and radium-223. In general, the agents approved to treat prostate cancer have varying mechanisms of action and favorable toxicity profiles, which provides an abundance of potential for novel combinations."

www.onclive.com/onclive-tv/Dr-Dreicer-on-Potential-Combinations-in-Prostate-Cancer


Dr. Slovin on Prostate Cancer Immunotherapy Evolution
Susan F. Slovin, MD, PhD
Published Online: Monday, March 18, 2013

"Susan F. Slovin, MD, PhD, an associate member in the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center, summarizes the development of an effective immunotherapy for the treatment of men with prostate cancer.

The initial phase I/II trials examining immunotherapeutic approaches in prostate cancer were not successful, Slovin states. Many of these agents were tested as single agents and were largely ineffective. However, these early trials successfully demonstrated that an immune response could be elicited in patients with prostate cancer.

Now for the first time, Slovin notes, with sipuleucel-T (Provenge), an immune product vaccine has extended overall survival. By and large, Slovin notes, researchers are still examining the mechanism of action for sipuleucel-T, to further understand how the agent successfully generates a biologic response.

www.onclive.com/conference-coverage/ipcc-2013/Dr-Slovin-on-Prostate-Cancer-Immunotherapy-Evolution

very good news, 49packard. great car too, if you own one

david in sc

Dr. Gomella on Sequencing Prostate Cancer Therapies
Leonard G. Gomella, MD
Published Online: Monday, March 25, 2013

Leonard G. Gomella, MD, professor and chair of the Department of Urology at the Thomas Jefferson University Hospital Kimmel Cancer Center, discusses the information currently available on sequencing the recently approved treatments for men with metastatic castration-resistant prostate cancer (mCRPC).

Gomella believes that researchers will be studying optimal therapeutic sequences in mCRPC for 3 to 5 years. Several agents have been recently approved and many more are still awaiting approval. At this point, Gomella adds, data are not available to support an optimal sequence, with one caveat, sipuleucel-T (Provenge).

Overall, Gomella notes, a consensus is emerging that sipuleucel-T should be administered earlier in asymptomatic patients who have recently been diagnosed with metastatic disease. Outside of sipuleucel-T, Gomella notes, researchers are still examining the optimal sequence for other recently approved agents, including cabazitaxel (Jevtana), abiraterone acetate (Zytiga), and enzalutamide (Xtandi).

www.onclive.com/onclive-tv/Dr-Gomella-on-Sequencing-Prostate-Cancer-Therapies

Let me give you an example as to why I'm so 'hot' on men (and women) being aggressive when it comes to advocating for their own health care.

Last year, I had a sinus infection. The doc I saw wanted to prescribe Leviquin. "No way," sez I. When the doc asked why, I reminded him that I worked out seven days a week. On three of those days, I use weights for an hour and a half. Leviquin is associated with tendon ruptures in the elderly. So, if I took that drug, I'd have to quit the gym for 10 days (probably more)...and that meant even the treadmill. I asked for Cefdiner, and he immediately wrote a prescription for that drug. It cleared the infection in 20 days. But at least it was 'safe' in the sense it didn't put my tendon's at risk.

Here's what triggered my request:

Update: Settlement Reached in Levaquin Case: Some 845 plaintiffs in the federal Levaquin multidistrict litigation have reached settlements with manufacturer Johnson & Johnson over alleged personal injury claims. Read more.

The FDA ordered a 'black box' warning to be placed on Levaquin in 2008 informing patients of increased risk of tendon ruptures most commonly in the Achilles tendon. Reports indicate that the risk of tendon ruptures may be increased when Levaquin is used in combination with steroid medications especially in the elderly.

http://www.zimmreed.com/Levaquin-Tendon-Rupture/16132/

We certainly have nothing to lose, and everything to gain, by arming ourselves with as much information as possible and by ENGAGING our caregivers in intelligent conversations regarding the OPTIONS available to us. This is what's behind my motives in posting here, regardless of whether I'm talking about Provenge, Zytiga, or Xtandi.

Be well.

Sun

I have been watching this thread and other Provenge related threads very closely and sincerely appreciate all of the inputs, please keep them coming!

Both my local and 2nd opinion oncologists were not advocates of Provenge, with both expressing the cost-to-benefit argument ($90k/4mo survival). Thanks to your posts here, I feel strongly armed to argue against this cost/survival position.

Other than cost however, one other concern raised was that of having an aggressive cancer going essentially unchecked during the 6mo waiting to see if the Provenge treatment is working. What is recommended during the treatment phase to assess whether or not Provenge is working, or if things might be getting worse? If conditions should appear to be getting worse during the treatment, can you augment with something else (e.g. chemo) and finish all treatments?

I’m not castrate resistant yet, but both oncologists have suggested that I may have a short run on HT, based upon my stats. I’d be eager to get started with Provenge as soon as I “qualify” as hormone refractory. I believe my Ins policy does contain the “PSA of at least 5 ng/ml over the reference value” requirement, which I would seriously fight, since the data suggests starting as early as possible, and at lower PSA levels.

Are there actions that I can take to minimize the time between becoming castrate resistance to start of Provenge treatment? Or am I over thinking the benefits of minimizing this time frame?

I’m hoping to persuade my oncologists to agree to prescribe Provenge as my next therapy, if I'm convinced that Provenge is right for me (rather than look for one who will).

Thanks in advance!

Adjust and Pepsiguy,

If you are both thinking about Provenge you should contact Todd1963 and get the real life story about how Provenge has worked so well for him. He was also told by ONC and insurance that it would only add 2 to 4 months of survival and had to fight get the treatments last year. I had dinner with Todd last week in Atlanta as part of his Provenge national tour.  He describes Provenge as a miracle therapy that jumps starts your body's immune system to fight the cancer and allow other drugs like Casodex, Zytiga and others to do their work more efficiently after the infusions. Todd keeps his email link open on HW and will discuss Provenge with anyone. He also can help you fighting any of the red tape you may find yourselves up against to get approved for treatment and insurance payments. Good luck to you both.

Terry

Adjust,

I am in shock to read when doctors talk about the cost-to-benefit argument in any medical treatment and special in Provenge case. For me they don't do they Job - follow The Hippocratic Oath that they will uphold a number of professional ethical standards. I will change these doctors very quick for other doctors that put their patients first and for whom The Hippocratic Oath mean something and they practice medicine ethically and honestly.
Ask your doctors if they prescribe Zytiga ( no OS in preChemo setting and also 4 month survival afterChemo ) and Xtandi ( OS 4 month afterChemo). You need to take Zytiga and Xtandi for 8- 16 months that have chance to live longer that people who didn't take them and price will be the same like Provenge + price to treat SE and maybe even hospitalization.
I am so devastated to read it because on Febroary 14 I told Raddad how his doctor was wrong to talk about cost and wrong about Provenge and how I feel bad that I didn't come one year ago answer his question about Provenge. It is why I become so advocate for this treatment and post on this Massage board about Provenge. It was my guilty feeling and now become TRIBUTE TO RADDAD IN HIS MEMORY.( You can read in this topic about my answer to Raddad).

If your doctors don't have time or other reason to educate themselves about Provenge , print them "Building on Sipuleucel-T for Immunologic Treatment of Castration-Resistant Prostate Cancer " by Neal D. Shore, MD, FACS, Constantine A. Mantz, MD, Daniel E. Dosoretz, MD, Eduardo Fernandez, MD, PhD, Francisco A. Myslicki, BA, Candice McCoy, MD, Steven Eric Finkelstein, MD, Mayer N. Fishman, MD, PhD from Cancer Control Journal January 2013.

Highlight :" Subjects in the control groups of all three trials were allowed to cross over at disease progression to receive treatment with a similar autologous product, APC8015F. This treatment was not randomized and was given at investigator discretion with patient consent. The manufacturing process for APC8015F was identical to that for sipuleucel-T, but APC8015F was produced using the frozen PBMCs obtained from the original leukapheresis rather than a fresh leukapheresis.

For the IMPACT trial, 64% of control subjects (n = 109) crossed over to receive APC8015F. The median OS for control subjects who crossed over compared with those who did not was 23.8 months vs 11.6 months. Of note, subjects who received APC8015F had more favorable prognostic features than did those not receiving APC8015F. Subsequent analyses adjusting for prognostic factors around the time of disease progression still revealed a positive treatment effect for APC8015F.

Thus, it is possible that the true magnitude of OS difference was underestimated in the primary analysis of the phase III trial results."

www.moffitt.org/research--clinical-trials/cancer-control-journal/from-bench-to-bedside-bringing-immunotherapy-into-the-clinic

Tell your doctors why such prominent Drs as Shore, Cooperberg, Lance, Myers, Vogelzang, Petrylak, Dreicer, Gomella, Scholz, Beer, Sartor, Oh, Fong and many more support Provenge and exiting about this treatment. Print them everything I gave link under Provenge and what these doctors said about Provenge and give it to them. It is time for them to educate themselves.
Don't forget to tell your doctors Provenge only drug that have the NCCN Cat. 1 rating in the pre-chemo setting.

I know many men with agressive cancer worry if Provenge right for them and they don't want wait 6 months to see if it work.
First I would like to tell look at some members of this board who with very aggressive cancer had Provenge and have outstanding result: 49packard, Todd1963, Devasted1. Those men that think that Provenge doesn't work for them but they have excellent result from other treatments. It can be also contributed by Provenge.

Remember Dr. Scholz said:"once the immune system is activated, it keeps functioning indefinitely; it’s the gift that keeps giving for the rest of your life. Therefore, even if Provenge only slows disease growth slightly, the inhibitory effect keeps accumulating over time. So over a period of years, even a mild effect can become substantial."

Dr. Sartor:" you treat a population of men in this way and they live longer than the population of men not treated in this way."

Dr.Eisenberger:" It’s possible that the interaction between immunomodulation and other treatments may be important... So it is also possible that immunotherapy may enhance subsequent treatment."

From Genitourinary ("2013 GU") Cancers Symposium was very important development for combination Provenge with other therapy. You can read :"The Growing Understanding of the Potential Influence of Immunotherapy in Prostate Cancer" by Ravi A. Madan, MD, and William L. Dahut, MD.

"Androgen-deprivation therapy (ADT) can also enhance the immune response. Clinical data have demonstrated that ADT traffics T cells to the prostate and decreases immune tolerance to self-antigens overexpressed on prostate cancer cells.7,8 ADT also induces the thymus to produce naïve T cells that can be activated by immunotherapy.9 Given these effects, ADT combined with immunotherapy presents an attractive therapeutic opportunity. A recent study combining sipuleucel-T and ADT in patients with biochemical recurrence has completed accrual and results are pending (NCT01431391).

Although there are concerns about potential immunosuppressive effects of prednisone (a requisite component of abiraterone and chemotherapy in mCRPC), no clinical data have suggested that the immune effects or potential clinical benefits of sipuleucel-T are altered by subsequent prednisone-containing treatment regimens. In fact, an analysis of immune cells after 6 months of docetaxel-based therapy found no effect on immune-cell function.10 An ongoing trial investigating the sequential or concurrent use of abiraterone and prednisone with sipuleucel-T could provide clinical data that resolve these concerns (NCT01487863). "

gucasym.asco.org/growing-understanding-potential-influence-immunotherapy-prostate-cancer

So you can start again ADT or continue with Zytiga, Xtandi or Chemo and don't wait 6 months.

You can read:""Toward Maximizing Immunotherapy in Metastatic Castration-Resistant Prostate Cancer – Rationale for Combinatorial Approaches Using Chemotherapy" by Dr.Slovin.
In this paper, an exploratory analysis of phase III trial (PROVENGE) participants found a substantial survival benefit to receiving docetaxel some months after sipuleucel-T:
"An exploratory post hoc analysis of docetaxel with or without early sipuleucel-T found that there was a benefit to receiving docetaxel some months after sipuleucel-T. Median survival was 34.5 months for patients who received sipuleucel-T followed later by docetaxel (N = 51); 25.7 months for crossover placebo recipients who also received docetaxel (N = 21); and 20.2 months for placebo patients who received docetaxel without ever receiving a vaccine product (N = 10). The adjusted survival hazard ratio (HR) for the first of these groups compared with the others was 2.53 (P = 0.006; Petrylak et al., 2007; Petrylak, 2011)."
So we see:

PROVENGE + CHEMO = 34,5;

FROZEN PROVENGE ( crossover placebo patient ) + CHEMO = 25,7;

PLACEBO + CHEMO = 20.2;

IT is very impressive.

www.ncbi.nlm.nih.gov/pmc/articles/PMC3362835/?tool=pubmed

Whatever decision anybody make, it will be the most important decision-- never look back and think I could go with this treatment but I didn't do it and now I missed that chance and it is too late for me.

Post Edited (HOPENEVERDIE) : 4/7/2013 9:11:19 AM (GMT-6)