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Revised View Enhances Provenge OS Data
Anita T. Shaffer
Published Online: Thursday, April 19th, 2012
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Leonard G. Gomella, MD
The Bernard W. Godwin Jr. Professor of Prostate Cancer Chairman, Department of Urology Director, Clinical Affairs Kimmel Cancer Center Thomas Jefferson University Philadelphia, PA
A further analysis of clinical trial data for sipuleucel-T (Provenge) suggests that the therapeutic prostate cancer vaccine may have delivered a greater overall survival (OS) benefit than previously described in the study that paved the way for its approval nearly two years ago, according to a leading researcher.
In fact, the analysis indicated that the survival benefit may be significantly higher than the 4.1-month advantage reported in the IMPACT study when the experiences of patients in the control arm who crossed over to a cryopreserved form of the vaccine are considered, said Leonard G. Gomella, MD, chairman of the Department of Urology and director of Clinical Affairs at the Kimmel Cancer Center, Thomas Jefferson University, in Philadelphia, Pennsylvania.
Gomella discussed his hypothesis at the 5th Annual Interdisciplinary Prostate Cancer Congress (IPCC) March 31 in New York City, for which he served as a program director. The research was presented at the 2012 Genitourinary Cancer Symposium sponsored by the American Society of Clinical Oncology (ASCO) in February and at the 2011 ASCO Annual Meeting.
Gomella’s comments come amid continuing controversy over sipuleucel-T, including a recent commentary in the Journal of the National Cancer Institute that maintained previously unpublished data cast doubt on the vaccine’s survival benefit partly because of factors involving patients in the placebo arm.
The FDA approved Provenge on April 29, 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant, hormone-refractory prostate cancer based on clinical trial data demonstrating that patients who took the vaccine experienced a median OS of 25.8 months versus 21.7 months for those who received a placebo.
Sipuleucel-T is custom-manufactured for each patient from antigen-presenting cells that are harvested from the patient through the process of leukapheresis, then cultured to activate immunogenicity, and infused into the patient. The treatment course consists of three intravenous infusions.
In his analysis, Gomella looked more closely at participants in the control arms of three randomized, double-blind sipuleucel-T studies. Of 249 people in the control arms, 216 participants who experienced disease progression had the option of receiving APC8015F, an autologous immunotherapy with the same potency as sipuleucel-T that was made for each patient and cryopreserved at the time the placebo was prepared.
For the 155 patients from the control arm who received APC8015F, the median OS was 23.6 months from randomization and 20.0 months following disease progression, which compared favorably with the median OS in the sipuleucel-T arms of 25.4 months from randomization and 20.7 months after progression.
In contrast, the 61 participants from the control arm who experienced disease progression but did not cross over to APC8015F had a median OS of 12.7 months from randomization and 9.8 months following disease progression.
“The survival difference was dramatically different,” Gomella said during his IPCC presentation. “So in a way, the sipuleucel-T trials shot themselves in the foot because the frozen product was included. If you exclude the frozen product, you actually get a much more dramatic and a much more robust response of about 10 to 12 months.”
In an interview, Gomella added, “From my viewpoint, the benefit of sipuleucel-T has been understated because many of the patients who received the frozen product who were on the control arm actually enjoyed a longer survival, decreasing the difference between the control arm and the treatment arm.
“In fact, if you look at our analysis of the patients who received a frozen product on the control arm and those who did not receive it, there was a significant survival advantage to those patients who did receive the frozen product,” said Gomella. “It made the difference between the control arm and the actual treatment arm much closer. And if you take out those patients who did not receive the frozen product on the control arm, that survival difference actually approaches 10 to 11 months.”
Gomella’s analysis stands in sharp contrast to the contentions of Huber et al, who argue that previously unpublished trial data show worse OS in older versus younger patients in the placebo groups, and that the difference may stem from the study design.
Patients on placebo who were younger than age 65 experienced an 11-month median survival advantage when compared with those over age 65 (28.2 months vs 17.2 months, respectively), the authors said. They contend that the placebo intervention itself may have adversely affected older patients in the placebo arm and therefore enhanced the sipuleucel-T survival advantage.
“Because two-thirds of the cells harvested from placebo patients, but not from the sipuleucel-T arm, were frozen and not reinfused, a detrimental effect of this large repeated cell loss provides a potential alternative explanation for the survival ‘benefit,’” the authors said.
In his IPCC presentation, Gomella said researchers are debating the impact of extracting immune cells, but that a study pending publication indicates the “number of immune cells you pull out of the body with leukapheresis is clinically insignificant.”
Meanwhile, Dendreon Corporation, the Seattle, Washington, company that developed Provenge, is continuing to investigate the vaccine for patients with earlier-stage disease.
Alles wird gut! ;)
STAY LONG
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Is Provenge better than previously reported?
Submitted by Ross Bonander Sun 04/22/2012
According to a fresh look at the data that got Provenge approved as the first and only therapeutic prostate cancer vaccine two years ago, the treatment might actually offer greater benefits than those initially reported.
The FDA approved Provenge (sipuleucel-T) at the end of April 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant, hormone-refractory prostate cancer. Approval was based on clinical trial data showing that patients who took the vaccine experienced a median overall survival (OS) of 25.8 months versus 21.7 months for those who received a placebo, or an improvement of 4.1 months.
A study published in the New England Journal of Medicine estimated that the treatment cost approximately $93,000 to administer.
However, according to Leonard G. Gomella, MD, chairman of the Department of Urology and director of Clinical Affairs at the Kimmel Cancer Center, Thomas Jefferson University, in Philadelphia, the overall survival benefit offered by Provenge is closer to 10 or 11 months, more than double what had been previously reported.
Dr. Gomella presented this hypothesis at the 5th Annual Interdisciplinary Prostate Cancer Congress (IPCC) in New York City. While it is being greeted with approval from Provenge supporters, it is in stark contrast to the original findings, and the analysis must undergo peer review before it sees any widespread approval.
Source: OncLive
UPDATE 1-FDA rejects Amgen's application for Xgeva
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Thu Apr 26, 2012 11:37pm EDT
April 26 (Reuters) - U.S. health regulators rejected the application by Amgen Inc, the world's biggest biotechnology company, to expand the use of the drug Xgeva to delay the spread of tumors to the bone in patients suffering from advanced prostate cancer.
Xgeva and a related osteoporosis drug Prolia are seen as among the most important growth drivers for Amgen and may help offset declining sales of anemia drugs, analysts say.
The Food and Drug Administration (FDA) has determined that the risks outweigh the effect of the proposed application and has asked for data from adequate and well-controlled trials, Amgen said.
Xgeva is already approved to prevent fractures in patients with advanced prostate cancer that has migrated to the bone. Amgen is seeking additional approval for use to postpone or prevent the cancer's spread.
The FDA rejected the expanded use of the injectable drug, known chemically as denosumab, after an advisory panel voted against it because of its links to a jawbone-destroying condition.
"We will work with FDA to determine any next steps," said Sean Harper, executive vice president of research and development at Amgen.
The FDA's action does not impact the approved indication of Xgeva in the prevention of fractures in men suffering from advanced prostate cancer, Harper said.
In the first quarter of 2012, sales of Xgeva rose 14 percent from the prior quarter to $153 million, and it is expected to eventually become a $1 billion-a-year drug.
The company said the new use for Xgeva would be targeted at about 50,000 men in the United States in the advanced stage of prostate cancer.
Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer.
Shares of Amgen closed up 0.85 percent at $70.79 on Nasdaq.
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Dendreon Announces Data Presentation at the 2012 American Urological Association Annual Meeting
Press Release: Dendreon Corporation – 33 minutes ago.. .
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SEATTLE--(BUSINESS WIRE)--
May 21, 2012–Dendreon Corporation (NASDAQ: DNDN) today announced the following PROVENGE® (sipuleucel-T) data will be presented at the American Urological Association (AUA) Annual Meeting taking place May 19 – 23, 2012 in Atlanta, Georgia.
• “Sipuleucel-T in African Americans: A Subgroup Analysis of Three Phase 3 Trials of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer,” abstract #953. Moderated Poster Session, Prostate Cancer: Advanced III from 10:30 a.m. to 12:30 p.m. ET on Monday, May 21, 2012.
• “Estimating the Overall Survival Benefit of Sipuleucel-T in the IMPACT Trial Accounting for Crossover Treatment in Control Subjects with Autologous Immunotherapy Generated From Cyropreserved Cells,” abstract #683. Oral Presentation, Prostate Cancer: Advanced 1 Podium from 3:30 to 5:30 p.m. ET on Sunday, May 20, 2012.
“These data continue to support the overall survival benefit of PROVENGE, an important treatment option for men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer,” said Mark Frohlich, MD, executive vice president and chief medical officer. “As shown in Phase 3 clinical trials, PROVENGE demonstrated an overall survival benefit and represents an important treatment option for men with advanced prostate cancer.”
Abstract #953: Sipuleucel-T in African Americans: A Subgroup Analysis of Three Phase 3 Trials of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
This exploratory analysis evaluated the survival benefit associated with PROVENGE in the African American men who participated in the three PROVENGE Phase 3 studies, including the IMPACT trial. Among 737 patients with metastatic castrate resistant prostate cancer, 488 were randomized to receive PROVENGE (African American, 33; Caucasian, 437; other races, 18) and 249 were randomized to the control arm (African American, 10; Caucasian, 229; other races, 10). Cox proportional hazards regression analysis was used to assess the treatment effect on overall survival in all randomized patients and the African American subpopulation.
The results of the African American subgroup suggested a positive treatment effect (HR=0.288 [95% CI: 0.125, 0.662]; P = 0.003). The exploratory analysis showed that African American men treated with PROVENGE had median overall survival benefit of 45.3 months versus 14.6 months in the control arm, a median survival difference of 30.7 months.
While no definitive conclusions can be drawn given the limited sample size, the results suggest that African American patients with metastatic castrate resistant prostate cancer benefit from treatment with PROVENGE and provide support for further investigation of this hypothesis. There were no statistically significant differences between race groups. Baseline factors for the African American population relative to the overall population included more exposure to prior chemotherapy, and lower age, baseline hemoglobin, ECOG status and bisphosphonate use. Adverse events for the African American subgroup were comparable to the overall study population.
“African American men are at the highest risk for prostate cancer in the United States and suffer a death rate 2.4 times higher when compared to Caucasian men and men of other ethnic groups,” said Thomas A. Farrington, president and founder, Prostate Health Education Network, Inc. “As a member of this community and a leader of an organization focused on eliminating health disparity, I welcome the data presented today. There is a great need for new treatment options for Black men.”
“The exploratory analysis suggests African American men with metastatic castrate resistant prostate cancer benefit from treatment with PROVENGE,” said David McLeod, MD, Center for Prostate Disease Research, Uniformed Services University, Bethesda, Maryland. “These data support further evaluation of the survival benefits associated with PROVENGE in appropriate African American advanced prostate cancer patients.”
Abstract #683: Estimating the Overall Survival Benefit of Sipuleucel-T in the IMPACT Trial Accounting for Crossover Treatment in Control Subjects with Autologous Immunotherapy Generated From Cyropreserved Cells
The Phase 3 IMPACT trial included a crossover design that allowed patients who were randomized to the control arm and experienced disease progression the opportunity to participate in an open label Phase 2 protocol to receive APC8015F, an investigational autologous cellular immunotherapy made from cells that were cryopreserved at the time the control was manufactured. As a result, 109 out of the 171 control patients (64%) received APC8015F.
In this exploratory analysis, researchers used a rank-preserving structural failure time (RPSFT) model, to quantify how treatment with APC8015F might have impacted the overall survival of the Phase 3 IMPACT trial by adjusting for the positive treatment effect of APC8015F in the control arm. The previously published intent to treat analysis, which is described in the Food and Drug Administration approved prescribing information for PROVENGE, did not account for cross-over and demonstrated a 4.1 month median survival benefit (HR=0.775, 95% CI: 0.614, 0.979). Using the RPSFT model, and assuming that APC8015F was equally effective as PROVENGE, the median overall survival benefit of PROVENGE in the Phase 3 IMPACT trial was estimated to be 7.8 months, had there been no cross-over to APC8015F (HR=0.60, 95% CI: 0.41, 0.95).
“This exploratory analysis provides important insight into how the cross-over design of the IMPACT trial may have affected the overall survival findings,” said Leonard Gomella, MD, Kimmel Cancer Center of Thomas Jefferson University. “These data support the use of PROVENGE as a foundation of care for the treatment of metastatic castrate resistant prostate cancer.”
About the IMPACT Trial
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) is a 512-patient, multi-center, randomized, double-blind, controlled study evaluating men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The primary endpoint was overall survival.
Primary results from the IMPACT study found PROVENGE extended median survival by 4.1 months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5 percent compared to control. Control used in the trial was non-activated autologous peripheral blood mononuclear cells. The survival benefit associated with PROVENGE was observed consistently across multiple patient subgroups, including those with prognostic factors known to be adversely correlated with overall survival, such as PSA, LDH, alkaline phosphatase, number of bone metastasis, Gleason score, performance status, and presence of pain.
Adverse events more commonly reported in the PROVENGE arm of this study included chills, fever, headache, influenza-like illness, muscle aches, hypertension and groin pain.
PROVENGE® Indication and Important Safety Information
PROVENGE® is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.
About Dendreon
http://cancernewsdigest.com/prostate-cancer/...al-in-fort-lauderdale/
Alle koennen nicht so viel geld fuer provenge ausgeben, wie soll es dann ein standard mittel werden?
bei Dendreon zu dem Preis Riskieren kann.
Erholung Potenzial 30-40 %
Wer sich die Kurse mal am Freitag angeschaut hat, wird merken, dass hier ganz schön in die Trick Kiste gegriffen worden ist!!!
Quelle:
http://www.finanznachrichten.de/...n-human-genome-uebernehmen-118.htm
16.07.2012 | 07:54
GLAXO kann HUMAN GENOME übernehmen
Offenbar kann Glaxo-Smithkline nach einem Ringen um eine feindliche Übernahme von Human Genome das Unternehmen nun einvernehmlich übernehmen. Human Genome hat sich h nämlicim Grundsatz mit dem Kaufangebot zum Preis von rund 14 $ je Aktie in bar bereiterklär. Zuvor hatte Glaxo 13 $ je Aktie geboten. Die Übernahme hat ein Volumen von mehr als 2,6 Mrd. $.
Der größte britische Pharmakonzern will sich mit dem Kauf von Human Genome den Zugriff auf eine Reihe vielversprechender Wirkstoffe in der Entwicklung sichern. Dazu gehören neue Medikamente gegen Herzerkrankungen und Diabetes. Beide Arzneimittelhersteller arbeiten schon lange zusammen.
Dendreon wird die nächsten Tage vom Kurs her aus der Meldung Profitieren.
Ab April wo das Übernahme Angebot raus war.
https://www.cortalconsors.de/Kurse-Maerkte/Aktien/...D-SHARES-DL--001
https://www.cortalconsors.de/Kurse-Maerkte/Aktien/...ED-SHARES-DL--01
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He identified studies involving these agents as the most noteworthy:
Sipuleucel-T (Provenge; Dendreon)—The therapeutic vaccine, which the FDA has approved for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC), is being investigated for earlier-stage disease. The vaccine is custom-manufactured for each patient by harvesting his antigen-presenting cells (APCs) through leukapheresis and culturing the APCs with immune-stimulating cells. The activated APCs are then infused into the patient. The process is repeated three times.
...
“Sipuleucel-T being FDA-approved now for almost two years and being used clinically is a great thing to have for our patients,” he said. ...
http://www.onclive.com/publications/Oncology-live/...Appear-Promising
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Drecks-Shorties und Manipulierer, vielleicht kriegen die auch mal Prostatakrebs und Provenge wird diesen korrupten Schweinen verwehrt!
Provenge should be the first-line choise for minimally or astymtomatic CRPC!
Dendreon (DNDN) is a biotechnology company focused on the discovery, development and commercialization of therapeutics that may improve cancer treatment options for patients. This stock is trading up 4.3% at $4.99 in recent trading.
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52-Week Range: $4.17-$17.04
Volume: 4.3 million
Three-Month Average Volume: 4.9 million
>>5 Big Stocks Ready to Slingshot Higher
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Sipuleucel-T Data To Be Presented At The ESMO 2012 Congress (European Society for Medical Oncology)
Press Release: Dendreon Corporation – 1 hour 43 minutes ago
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SEATTLE--(BUSINESS WIRE)--
September 27, 2012--Dendreon Corporation (NASDAQ:DNDN) today announced the first patient enrollment and initiation of treatment for the sipuleucel-T European Union (EU) open-label study. The open-label study is being conducted in European men with metastatic castrate-resistant prostate cancer (mCRPC) to describe product release parameters and report on safety in a European population. The study may enroll up to 45 patients in four sites across the EU. Dendreon has submitted a marketing authorization application (MAA) for sipuleucel-T which is currently under review by the European Medicines Agency (EMA). Sipuleucel-T is not approved for use outside the U.S. Sipuleucel-T is approved by the Food and Drug Administration (FDA) in the U.S. for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. It is marketed under the name PROVENGE®.
"We are extremely pleased with the progress of this new study and that the first patient has begun his treatment," said Thomas Powles MD, MRCP, Barts Cancer Institute, St. Bartholomew's Hospital, London. "We are also excited about the potential study outcomes and look forward to a successful program with the support of our committed clinical team and dedicated patients."
In addition to the current EU open-label study, the following data presentations are taking place at the ESMO 2012 Congress in Vienna, Austria, 28 September –2 October:
Saturday, September 29, 13:00-14:00 CEST – Abstract #939P: “Neoadjuvant Sipuleucel-T in Localized Prostate Cancer: Effects on Immune Cells within the Prostate Tumor Microenvironment.” Poster presentation.
Saturday, September 29, 13:00-14:00 CEST – Abstract #940P: “Overall Survival Benefit with Sipuleucel-T by Baseline PSA: An Exploratory Analysis from Three Phase 3 Trials.” Poster presentation.
Saturday, September 29, 13:00-14:00 CEST – Abstract #941P: “Impact of Salvage Therapy with AC8015F on the Overall Survival Benefit Achieved with Sipuleucel-T in Three Phase III Studies of Metastatic Castrate-Resistant Prostate Cancer. Poster presentation.
Saturday, September 29, 13:00-14:00 CEST – Abstract #943P: “OpenACT: Phase II, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (mCRPC).” Poster presentation.
Saturday, September 29, 13:00-14:00 CEST – Abstract #942P: “Antigen Presenting Cell (APC) Activation in Sipuleucel-T: Is Activation Increased in Earlier Prostate Cancer Disease States?” Poster presentation.
Indication and Important Safety Information
Approved for use in the U.S. only.
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For the FDA approved full prescribing information, please visit http://www.provenge.com.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
Prostate Cancer Vaccine
Number: 0802
Policy
Note: REQUIRES PRECERTIFICATION.*
Aetna considers sipuleucel-T (Provenge) medically necessary for the treatment of adults with metastatic castrate-resistant prostate cancer who are asymptomatic or minimally symptomatic with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and who have no liver metastases and a life expectancy of greater than 6 months (see Appendix).
Aetna considers sipuleucel-T experimental and investigational for other indications (e.g., prevention of prostate cancer and treatment of localized prostate cancer) because its effectiveness for these indications has not been established.
Note: * Precertification of sipuleucel-T is required of all Aetna participating providers and members in applicable plan designs. For precertification of sipuleucel-T, call (866) 503-0857, or fax (866) 267-3277.
See also CPB 521 - Prostate Cancer Screening, CPB 698 - Prostate Saturation Biops