provenge

Here's an interesting case where Provenge was sequenced with Xtandi:

http://seekingalpha.com/article/1218101-dendreon-startling-results-sequencing-provenge-after-medivation-s-xtandi

Poster from AUA2013:

OPTIMAL TIMING FOR TREATMENT OF METASTATIC CASTRATION -RESISTANT PROSTATE CANCER (mCRPC):
SEQUENCING AND IDENTIFYING PARAMETERS OF EARLY PROGRESSION WITH SIPULEUCEL-T ( Provenge)


Data were collected from the following trials:

- NeoACT ( NCT00715104): an open - label, Phase 2 study investigating Provenge as a neoadjuvant treatment in me with localized prostate cancer;

- IMPACT ( NCT00065442) : a placebo - controled, Phase 3 study in men with asymptomatic or minimally symptomatic mCRC;

- ProACT( NCT00715078): a Phase 2 study in men with asymptomatic or minimally symptomatic mCRC;

- openACT( NCT00901342): an open - label, Phase 2 study in men with mCRPC;

- P11-3( NCT01487863): a randomized an open - label, Phase 2 trial investigating Provenge use with concurrent vs sequential administration Zytiga in men with mCRC

Evidence that supports unique MOA of Provenge:

- immune responses that associated with Provenge correlate with OS

- immune cells target the tumor site in men with localized prostate cancer ( NeoACT);

- immune cell activation continues well beyond infusion;

- it takes time for Provenge immune response to have an impact;

- Provenge significantly prolongs PSADT in ADPC;

- Provenge shows a progressively increasing treatment effect on end points that occur later:
OS > Time to first opoid analgestic > Time to disease-related progression > ODP (objective disease progression ) .


Optimal timing of Provenge within the mCRPC Treatment Paradigm: Rationale for early use:

-Provenge are potentially best given earlier in the course of disease' when tumor burden is low and immuno-competence is adequate;

Lowest PSA quartiles in IMPACT derived greatest OS Benefit:

- The magnitude of treatment effect in patients in the lowest quartile ( PSA < 22,1 ) appeared to be greater then those in the highest ( PSA > 134,1), 13 vs 2.8 months median OS benefit , respectively.

Optimal time to administer Provenge is when disease burden is lowest:

- Data support the idea that less aggressive disease kinetics allow more time for a positive treatment effect with Provenge.

Follow on Therapies:

- A treatment effect of Provenge was observed in both patients with and without CHEMO;

-Preliminary data from P11-3 ( saquenses Provenge+ Zytiga ) suggests that Provenge can be effective in patients in whom Zytiga are initiated concurrently with Provenge.

Conclusion

- Evidence suggest that Provenge should be given early in the MCRPC disease course;

- The non- overlapping MOA, short treatment course and manageable adverse event profile of Provenge accommodates follow-on therapy with either Zytiga, Chemo or other agents

www.urotoday.com/images/stories/conferences/aua/Optimal_Timing_for_Treatment_of_mCRPC-_Sequencing_and_Identifying_Parameters_of_Early_Progression_with_sip-T.jpg

JerryL,

This Poster was presented at AUA Annual Meeting that took place May 4-8 and become available to public on May 14. It is the most comprehensive and detailed analysis from several trials with Provenge. This information shows me what superior Provenge is. And should be foundation of treatment for patient who CRPC.
At AUA Dr.Shore notes he'd like to give Provenge on early PSA rise w/o having to do a bone scan, but insurers won't go for it, he said patients are mad at that "I have to get worse before I can get this drug" dilemma.
Many doctors on this meeting did not know many information about Provenge that (I hope) they learn from this Poster.
I think every M.Ds should have this Poster in his office, then patients don't need explain them about Provenge and they don't need learn from patients.

At AUA Dr. Quens noticed that among all patients he consideres are eligible for Provenge , only half of those agree to take it. That shows all damages that this drug received from negative bias against Provenge in Media.
But the most disturbing moment was when urologists were asked question what drug they will give to patient who is ideal candidate for Provenge - 68% in room say Zytiga. 8% say Chemo.

So it is good that you know everything and for you nothing knew ,

For many people even doctors it is still knew information and special :

1 Crawford was pointing out Provenge alters trajectory of PSA. Provenge significantly prolongs PSADT in ADPC ( remember last post of 49packard:
'Just got my result from my 3/19/2013 Tests at Johns Hopkins I feel great. PSA is slowing down Doubling time is taking longer Provenge is working''

2 Provenge shows a progressively increasing treatment effect on end points that occur later: OS > Time to first opoid analgestic > Time to disease-related progression > ODP objective disease progression ( many times I read on MB from patients that took Provenge and later they condition stabilize and they become doing better they think it is God work or just miracle like this posted on April, he had Provenge on September 2011 :

"My PSA is over a thousand. It was 2000 plus before I started Jevtana. I've done ten sessions of it and I'm gonna see my doctor on Monday. He informed me that my bone scan result was much better than the previous one which was last year. I feel fine except occasional back pain that goes away. I have stage 4 PCa with bone mets, diagnosed 3 yrs ago. I've been thru hormone therapy, ketoconazole, Provenge that didn't work, taxotere and lately, Jevtana. I don't know what's next but ones thing for sure, God is the greatest physician. Prayers help a lot. My MD is puzzled. My PSA is so high and yet he said I look alright."

www.inspire.com/groups/us-too-prostate-cancer/discussion/extremely-high-psas/

Our God is a healing God. My PSA last Feb was over 2000 from 1300 plus. The doc was planning to change my meds. He ordered another test and the latest was lower than the previous before Feb.
He asked the asst if the test was done by the same lab and it was. He was puzzled and asked to talk to the director of the Lab. He ordered a bone scan for me and last week they called me to inform me per MD's instructions that the result of the scan is much better than the previous ones.
Truly our God is an amazing one. Put your trust in Him and not to our own understanding."

www.inspire.com/groups/us-too-prostate-cancer/discussion/chicago-support-group-for-advanced-pca/

3 Preliminary data from P11-3 ( saquenses Provenge+ Zytiga ) suggests that Provenge can be effective in patients in whom Zytiga are initiated CONCURRENTLY with Provenge.

4 Provenge works by altering disease velocity.

5 Immune cell activation continues well beyond infusion and it takes time for Provenge immune response to have an impact.



At AUA2013 Dr. Soloway said 30% of pts relapsed to CRPC. It is more that 60,000 men. Last year 3,000 patients was treated with Provenge. How many more patients could benefit from this drug ?

Last Saturday I visited graduation from one of my relative. It brought memory Biden speaking at U of Penn Graduation in 2012.

www.youtube.com/watch?feature=player_embedded&v=q5LaYKUJ_w8

13:43 - 14:00
"The ability in the near term of engineering your white blood cells to attack cancer tumors and leave healthy cells untouched allowing cancer patients to live out their lives without undergoing difficult and painful chemotherapy and radiation procedures. "

June 14, 2012

www.whitehouse.gov/the-press-office/2012/06/14/remarks-vice-president-joe-biden-tallwood-high-school-graduation-ceremon

Remarks by Vice President Joe Biden at the Tallwood High School Graduation Ceremony

Tallwood High School
Virginia Beach, Virginia
"Imagine the progress you will see and achieve in your lifetime. Imagine those breakthroughs that are just on the horizon and just beyond it. Imagine the day, and it will occur within your lifetime -- it will occur in all probability before you have children -- when doctors can engineer your white blood cells to attack cancer tumors and leave healthy cells untouched, allowing cancer patients to live a full life without undergoing the difficult, painful and costly chemotherapy and radiation procedure."

on June 4, 2012 at Cypress Bay High School in Miami

drmicozzi.com/can-joe-biden-cure-cancer

“Imagine a day within your lifetime when doctors can and will engineer your white blood cells to attack cancer cells, and leave healthy cells untouched, allowing cancer patients to live out a full life without undergoing the difficulties some of you observe—painful chemotherapy and radiation procedures.”

It reminds me one drug that already available to PC patients for 3 years. It is name is Provenge.

My best to you

Post Edited (HOPENEVERDIE) : 5/20/2013 2:10:46 PM (GMT-6)

I discussed Provenge at my recent uro visit. He is in a practice that has about 45 urologists. A few like him only do prostate work. One of the partners is a urologic oncologist and is very well regarded in using Provenge. They have put several hundred men on Provenge. They are using Provenge as early as insurance will pay and they are finding that it enhances future treatments like chemo, second line HT, etc. They are very bullish on using it as early as possible.

For me they will keep me on quarterly monitoring of PSA indefinately and at the first rise will redo scans to aggressively look for mets at the earliest possible time so that Provenge can be started.

Mr.  Bill:

As far as I know (I'm using The Blues) the vets have the program but only one patient has been put on Provenge.

But call there hot line and ask.

1-877-336-3736

Best of luck

49packard

Hi pepsiguy : Vein assessment is very important  before you start Provenge . I went as far as to go to the Red Cross and have them check my veins. The side effects are almost none. (three hours is a long time to do the withdraw. ) My Provenge took six months to kick in.(give it time to work) Start 4-2012 PSA=9.26 (Provenge started 5/1/2012) First PSA=7-2012=21.05 Second 9-2012      =58.9  Third 1-2013        =132.0 (Provenge kicking in) Forth  3-2013        = 141.0 Fifth 5-13             =81.8 ( down by 59.2) As of May 20,2013 I finished a test trial at Johns Hopkins with PET scan, and they did not find any metastasis. Do not let the insurance Co tell you no, keep fighting it. Provenge hot line is first place to start.1-877-336-3736 Good Luck Keep us updated   "; font-size: 18pt; mso-bidi-font-size: 12.0pt;'> 49 Packard President Wheels for Prostate Cancer Research, Inc. Fighting PROSTATE CANCER   With PROVENGE www.WfPCR.org/      

  Hi All: Just got all reports form Johns Hopkins, after doing their Test Trial. They are great . No bone tumors anywhere. (metastatic) No tumors’ anywhere on either Ct scan, Bone scan, or PET scan . Mr. Packard is on cloud nine . It took eight years to get here. On the new PET scan one of the lymph nodes has shrank from 11mm down to 8 mm. Also smaller decrease is size of others lymph nodes in the pelvic area. President Wheels for Prostate Cancer Research, Inc. Fighting PROSTATE CANCER   With PROVENGE www.WfPCR.org/

Hope & Pack,
Well, I called the ""hotline" regarding the VA utilizing provenge..They were going to call me back but never did--oh well! All the best to you guys.
Bill

Dendreon presented studies evaluating PROVENGE and DN24-02 data at ASCO 2013 :


PROVENGE:

-- A Randomized Phase II Study Evaluating the Optimal Sequencing of
Sipuleucel-T and Androgen Deprivation Therapy (ADT) in
Biochemically-Recurrent Prostate Cancer (BRPC): Immune Results (Abstract
5016). Data suggest that combining ADT with sipuleucel-T may augment
adaptive immunity.

-- A Randomized Phase II Trial of Sipuleucel-T with Concurrent or Sequential
Abiraterone Acetate (AA) Plus Prednisone (P) in Metastatic
Castrate-Resistant Prostate Cancer (mCRPC) (Abstract 5047). In a Phase II
clinical study, the data suggest sipuleucel-T can be successfully
manufactured during concurrent AA plus P with no significant changes in
peripheral immune responses or alterations in adverse event profiles.

-- Impact of Prior Docetaxel on Sipuleucel-T Product Parameters in PROCEED
Patients (Abstract 5034). In an ongoing, Phase IV registry of patients
administered sipuleucel-T regardless of prior docetaxel use,] the data
suggest that antigen presenting cell activation in sipuleucel-T is not
impaired following docetaxel treatment.

-- open-Label, Multicenter Study of Sipuleucel-T in Men with Metastatic
Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with
Sipuleucel-T: Evaluation of Antigen Presenting Cell (APC) Activation and
ELISPOT Data (Abstract 5053). In a study designed to evaluate the product
potency in the retreatment of patients with sipuleucel-T, the data
indicate the presence of existing immunological memory to sipuleucel-T
years following initial treatment, and retreatment appeared to boost
product potency compared with prior treatment. The patients were
initially treated with sipuleucel-T when they had ADPC, and were
retreated after they developed mCPRC.



DN24-02 (UROTHELIAL CANCER):

-- Preliminary Safety, Product Parameters, and Immune Response Assessments
From A Phase II Randomized, open-Label Trial of DN24-02, an Autologous
Cellular Immunotherapy (ACI), In Patients with Surgically Resected HER2+
Urothelial Cancer at High Risk for Recurrence (Abstract 4547). In an
ongoing Phase II study, preliminary data on the adverse events and immune
response of DN24-02 indicate that antigen presenting cell activity is
comparable to that of sipuleucel-T and positive immune responses were
observed.

-- Preliminary HER2 Expression Data from NeuACT, the Phase II Randomized,
open-Label Trial of DN24-02 in Patients with Surgically Resected HER2+
Urothelial Cancer (UC) at High Risk for Recurrence (Abstract 4527). In an
ongoing Phase II study, preliminary data on HER2 expression in urothelial
cancer suggest a high incidence of HER2 expression (>74%) in urothelial
cancer primary tumor and lymph node specimens from patients, with higher
expression observed in lymph node specimens.

  Devasted1: Do you know or anybody else that got a booster shot of Provenge after PSA has stop dropping? What are the rules or out line to get the booster shot of Provenge? Does anybody know of any test trials for booster shot of Provenge? Just starting early to get information, always on the look for the next step. I know Provenge will only buy me a period of time. Still feeling great, just getting older.   President Wheels for Prostate Cancer Research, Inc. Fighting PROSTATE CANCER with PROVENGE www.WfPCR.org/

H openEVERDIE: Thanks for the comeback. Looked up the test trial of NCT01338012 for Provenge booster at Virginia Beach.   Talked to a wonder young lady Jennifer and she said their trial is closed. We had a wonder chat about Provenge and TAK 700. I am going to wait till Provenge stops lowering my PSA, then research new test trials. I have been extended an invitation to attend a Dr. only talk from Provenge. I will take my questions just in case I get a opportunity   to ask them. President Wheels for Prostate Cancer Research, Inc. Fighting PROSTATE CANCER   With PROVENGE www.WfPCR.org/

  Hi Provenge world:   Just a short report with what is going on in my life. At this juncture with blood tests, bone scans and Dr. Visits I get to give you some more great news. No bone Mets and that is with the new PET scan at Johns Hopkins. PSA have taken another fall. Not a fantastic drop, but still falling.   DOWN 2.3 This makes a total, this quarter, of -61.5 drop. PSA now at 79.5 down from start 141.0  Still cannot come off Lupron. Doctor said when I hit ZERO then I get a Lupron vacation. I am done with bone scan till PSA starts back up. Looking forward to a great 4 th of July.   President Wheels for Prostate Cancer Research, Inc. Fighting PROSTATE CANCER   With PROVENGE www.WfPCR.org/