Provenge as immunotherapeutic agent in the form of dendritic cell therapy in hormone resistant prostate cancer provides significantly longer survival. 3-year survival is 38% and improves median survival by 4 months (20%). A significant result. Phase III study shows. FDA has now approved this immunotherapy with dendritic cells. Added full study report and article in NEJM. Article updated May 2, 2011
July 31, 2010: In the NEJM - New England Journal of Medicine has an extensive article this week plus full study report published on Provenge, the immune therapeutic agent for hormone-resistant prostate cancer . The vaccine is in fact pure dendritic cell therapy has been approved by the FDA after Phase III study for a remarkable life extension has resulted in prostate cancer patients. Click here to NEJM article and more information on Provenge. NEJM article on there click on NE Journal of Medicine Article
May 1, 2010: The FDA has finally approved Provenge to be used as immune therapy in people with asymptomatic or minimally symptomatic metastatic, hormone-resistant prostate cancer (mCRPC). This immunotherapy is referred to as sipuleucel-T is an autologous active cellular immunotherapy, which means that it's made of white blood cells from the patient and stimulates the immune system of the patient to react against the cancer. The treatment must be individually manufactured for every patient says the press release. This seems logical if you get dendritic cells from the blood of the patient himself. Provenge is really just dendritic cell therapy . But read below about Provenge and the application and the studies that have done so.
May 3, 2009: Study Results added on April 16 last post by Medscape publication:
Medscape are now using the exact results from the Phase III study of Provenge released by dendritic cell therapy in hormone-resistant prostate cancer patients . To be clear this is such as Dr. Robert Gorter more or less works with dendritic cell therapy . Vaccines made of leukocytes and monocytes back into the body of the patient after any contact with tumor tissue from the patient himself. . See the video of Mr. Hagemeyer eg prostate cancer with the video button with dendritic cell therapy and hyperthermia treatments in clinical cancer by the Medical Center Cologne.
Here is the article from Medscape and below the previous reports about Provenge with dendritic cell therapy.
Results:
The study followed 512 men with a minimal or asymptomatic metastatic hormone-resistant prostate cancer that had spread - were randomized in a 2:1 mode for sipuleucel-T or placebo. The vaccine was obtained from the leucocytes of the patient, which were developed over a 2 - or 3-dageljkse period and then brought back into the patient intravenously on day 3 or 4. Three cycles were administered every month Sipuleucel T extended median survival by 4.1 months, median survival was 25.8 months and 21.7 months with active treatment with placebo.
3-year survival improved compared to placebo by 38% (31.7% vs. 23.0%).
"This 4-month prolongation in survival is particularly important," says Dr. Penson on Medscape Urology. "These patients have a life expectancy of about two years, so if you give them four months there is tameljk important. It gives them about 20% longer life. And [sipuleucel-T] does so with minimal side effects. So there is a better life with good quality of life.
"The IMPACT study achieved a P value of .032, a significant stats dramatically improve longevity," according to a press release Dendreon.
AUA 2009: Prostate Cancer Vaccine Significantly Improves 3-Year Survival
April 29, 2009 (Chicago, Illinois) - Phase 3 results from the Immunotherapy for Prostate adenocarcinoma Treatment (IMPACT) study, Presented here at the American Urological Association (AUA) 104th Annual Scientific Meeting, showed That prostate cancer immunotherapy with sipuleucel-T ( Provenge, Dendreon Corp..) extended median survival by 4.1 months and improved 4-year survival by 38%.
Results from the IMPACT study were presented by David F. Penson, MD, MPH, professor of medicine at the University of Southern California at Los Angeles. The study Involved 512 people with asymptomatic or minimally meta-static rate cast-resistant prostate cancer who were randomized in a 2:1 fashion to sipuleucel-T or placebo.
The vaccine was Manufactured from the patient's leukocytes, All which were expanded on a 2 - or 3-day period and then reinfused on day 3 or 4 on an outpatient basis. Given three cycles were over the course of a month.
Extended median survival Sipuleucel T by 4.1 months, median survival was 25.8 months and 21.7 months with active treatment with placebo.
Three-year survival was improved by 38% compared with placebo (31.7% vs. 23.0%).
"This 4-month extension in survival is very, very significant," Dr.. Penson told Medscape Urology. "These have a life expectancy Patients of about 2 years, so giving em 4 more months is pretty important. It gives em about 20% more life. And [sipuleucel-T] does it with minimal adverse events. So there is improved survival with good quality of life. "
Treatments were well tolerated extremely, with chills reported in 54.1% of Patients (versus 12.5% with placebo), fever in 29.3% (vs. 13.7%), headache in 16.1% (vs 5%), and flu-like symptoms in 9.8% (vs. 4.3%). Most adverse events lasted only a few days and were treatable with aspirin. "Some of Our Patients were golfing the day after treatment," Dr.. Penson told reporters.
"The IMPACT study Achieved a P value of .032, successfully Exceeding the prespecified level of statistical significance," According to a release Dendreon.
Last year, the U.S. Food and Drug Administration (FDA) approval or deferred sipuleucel Until a statistically significant T-improvement in survival Could be Shown.
"The company and the FDA have to get back together to re-Evaluate the results, but in my opinion, I think they Should approve it."
AUA spokesman J. Brantley Thrasher, MD, chair of the Department of Urology at the University of Kansas in Kansas City, Kansas, pointed out to Medscape Urology that "last year, the FDA put a damper on the approval process. They were looking for more survival data. Should this give it to em. "
"This Will cause a big splash," Dr.. Thrasher continued. "We do not have anything for Patient with hormone-refractory disease, which is very aggressive.... Improved survival with T cell immunotherapy is really very significant."
Dr. And Dr. Penson. Thrasher have disclosed no relevant financial relationships.
American Urological Association 104th Annual Scientific Meeting: Late Breaking Abstract 9: Presented April 28, 2009.
Finally is still accepted by the FDA that Provenge, an immunotherapeutic agent associated with dendritic cell therapy provides significantly better resutlaten in advanced prostate cancer . This sounds like very good news. Below the announcement of this decision on the Dendreon website and an article in The Los Angeles Times about this. For clarity Provenge is a drug that "origin" of the tumor in the patient himself. So this means is not a chemical but comes from the patient himself. This drug is then contacted with a laboratory in the dendritic clelen previously from the blood of the patient himself made and then returned to the cancer patient. Exactly like Dr Robert Gorter own work if there is tumor tissue available that have not been influenced by chemotherapy or radiation. 20 April, the full results from the Phase III study announced at a special press conference by Dendreon.
Provenge Significantly ProLong Survival in Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
- Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival -SEATTLE, April 14, 2009 - Dendreon Corporation (Nasdaq: DNDN) Announced today thats the pivotal Phase 3 IMPACT Study of Provenge ® (sipuleucel-T) in people with advanced prostate cancer with its primary endpoint of Improving overall survival compared to a placebo control . The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully Achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of Provenge appeared to be consistent with prior trials.
The 512-patient, multicenter, randomized, double-blind, placebo-controlled IMPACT (IM munotherapy for P rostate A denominations C arcinoma T reatment) study enrolled people with meta static androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
Source: Los Angeles Times :
Provenge is Dendreon's investigational product candidate for men with advanced prostate cancer and May represents the first in a new class of active cellular immune therapies specifically designed to engage the patient's own immune system against cancer.
Detailed results from the IMPACT Study Will Be Presented During a Plenary Session at the American Urological Association's Annual Meeting in Chicago on Tues., April 28 at 2:20 pm CT.
A controversial prostate cancer vaccine produced by Dendreon Corp.. of Seattle "significantly" improves survival of patient, the company said Tuesday morning without releasing Further details of the trial. The trial was designed to detect a minimum 22% Increase in survival and experts speculate thats it did at least That well. Further results of the Trial Will Be Released April 28 at a meeting of the American Urological Assn. Those Findings are upheld if, the vaccine, called Provenge, could be the first cancer vaccine approved by the Food and Drug Administration.
Provenge is a so-called therapeutic vaccine designed to treat the disease rather than Prevent it from Occurring. Physicians specialized immune cells called dendritic collect cells from the patient's blood, mix em with proteins Collected from the surface of tumor cells and inject em Back Into the patient in three doses at two-week intervals.
In an EARLIER study of the vaccine, the company found thats it Increased survival of Patients with advanced prostate cancer had spread beyond the prostate That by 18 weeks compared to a placebo Patients Given. After three years, 34% of Those in the vaccine group survived, compared to 11% in the placebo group Those. An FDA advisory committee recommended the agency approve the vaccine That for marketing, but the FDA disagreed, arguing thats the study did not Provide Evidence That the vaccine Slowed progression of tumors.
