23 februari 2005:: Bron: Biotechfind en Dendreon

Provenge, een immunotherapeutisch middel blijkt samen met Avastin bij de driejaarsmeting van een fase III studie voor significant betere resultaten, langere overleving, te zorgen dan placebo bij prostaatkankerpatiënten, aldus publicatie van Dendreon, de producent van Provenge. Een kleinschaliger fase II studie met prostaatkankerpatiënten waar operatie en bestraling niet voor definitieve genezing had gezorgd en toch weer een recidief was ontstaan zorgde ook voor hoopvolle resultaten met de combinatie van Provenge en Avastin. Voor OPS-leden hebben we adresgegevens van contactpersonen van Dendreon beschikbaar voor informatie over dit middel. Dendreon organiseert nu wereldwijd meerdere fase III trials met Provenge voor prostaatkankerpatiënten waarvan de Gleasonscore onder de 7 ligt, maar waar de prostaatkanker ondanks de hormoontherapie verder doorgroeit. Dus laten we hopen dat in Nederland snel enkele ziekenhuizen deze aanpak zullen aanbieden aan prostaatkankerpatiënten. Al vinden we het wel opvallend dat Avastin hierbij ook nadrukkelijk genoemd wordt. Avastin wordt namelijk enorm gepromoot over de hele wereld, maar wij zijn niet zo inder de indruk van de gepubliceerde resultaten van Avastin, zeker als we erbij bedenken dat dit soort trials vaak zo gebracht worden dat ze er positiever uitkomen dan de werkelijke praktijk echt laat zien. Zoals bv. ook recent nog met Iressa voor longkanker is gebeurd. Maar goed het resultaat van deze combinatie behandeling is wel na drie jaar al significant beter en wie weet wat er nog meer uit kan komen na vijf en tien jaar. Al vinden wij persoonlijk de aanpak met dendritische celtherapie interessanter als immuuntherapie dan de aanvulling Avastin bij prostaatkanker. Achtereenvolgens de publicatie van Biotechfind, een nieuwsmedium over de fase II studie en daarna van Dendreon over de studieresultaten van de driejaarsmeting van de fase III studie.

Dendreon Reports Combination of Provenge and Avastin Impacts PSA Doubling Time In Patients With Biochemically-Relapsed Prostate Cancer

ORLANDO, Fla., Feb. 19 /PRNewswire-FirstCall/ -- Dendreon Corporation (NASDAQ:DNDN) today announced that results from its NCI-sponsored Phase 2 study of Provenge(R), in combination with Avastin(TM) (bevacizumab), increased PSA doubling time (PSADT) in patients with prostate cancer that had relapsed after prior surgical and radiation therapy. Provenge is the Company's investigational immunotherapy for the treatment of prostate cancer.

The data were presented today by Brian Rini, M.D., assistant professor of medicine, University of California, San Francisco, at the 2005 Multidisciplinary Prostate Cancer Symposium.

Study Details & Results

Twenty-two patients with androgen-dependent prostate cancer who had undergone prior definitive surgical or radiation therapy were enrolled and treated in this Phase 2 trial, known as the P-16 study.

Provenge was given intravenously (IV) on weeks one, two and four. Patients were given 10 mg/kg of IV Avastin immediately following Provenge and continued every two weeks thereafter until disease progression or toxicity was observed. Disease progression was defined as a doubling of the baseline or nadir PSA value or the development of metastases. PSA measurements were recorded and PSADT was calculated.

The median pre-treatment PSADT for the 21 evaluable patients was 6.7 months and the median on-treatment PSADT was 12.7 months, an approximate 90 percent increase in PSADT (p = 0.004). Eight patients displayed at least a 200 percent increase (range, 212 percent - 758 percent) in PSADT while on study compared with their pretreatment rate of change. In addition, 41 percent of patients exhibited a decrease in their absolute PSA value from baseline (range, 6 to 72 percent). No patient on study had objective disease progression (defined as the onset of measurable bone or soft tissue metastatic disease). Four patients were removed from study due to toxicity (congestive heart failure, hypertension, cerebrovascular ischemia and proteinuria).

"These results provide encouraging proof-of-concept that Provenge can be safely combined and work synergistically with other immune-modulating therapies such as Avastin for the treatment of men with prostate cancer," said Dr. Rini. "PSA doubling time has become increasingly used as a measure of prostate cancer disease biology. The alteration in PSADT seen in this trial may reflect the biologic effect of this combination therapy. If proven effective, the combination of Provenge with Avastin, or other immune modulating therapies, could prove to be an appealing treatment alternative for prostate cancer patients."

Provenge is an active immunotherapy designed to stimulate the immune system to attack cells that express prostatic acid phosphatase (PAP), a protein expressed on approximately 95 percent of prostate cancer cells. Avastin is a VEGF inhibitor. VEGF is a pro-angiogenic protein with inhibitory effects on dendritic (DC) cells. VEGF inhibition with Avastin has been shown to result in enhanced tumor rejection after DC-based vaccination in pre-clinical models.

Dendreon's Phase 3 D9901 Trial Shows Provenge Extends Survival in Patients with Advanced Prostate Cancer -- Final Three-Year Survival Analysis Shows Statistical Significance in Favor of Provenge in Overall Intent-to-Treat Population -- -- Data to be Submitted for Presentation and Publication -- SEATTLE, Wash., October 28, 2004 - Dendreon Corporation (Nasdaq: DNDN) today announced that the data from the final three-year follow-up of its completed first Phase 3 study (D9901) of Provenge®, the Company's investigational immunotherapy for the treatment of prostate cancer, showed a statistically significant survival benefit in patients with advanced prostate cancer who were treated with Provenge. Prostate cancer is the number one non-skin cancer in the United States and the third most common cancer worldwide. The pre-specified 36-month final survival analysis of the double-blind, placebo-controlled study of Provenge in 127 patients with asymptomatic, metastatic, androgen-independent prostate cancer showed a statistically significant survival benefit in the overall intent-to-treat patient population, defined as all patients randomized in the study regardless of their Gleason score. This survival benefit is greater than that observed with any type of treatment in any published Phase 3 study in late-stage prostate cancer. In addition, at the 36-month final follow up, the percentage of patients alive in the Provenge-treated group is substantially greater than the percentage of patients who received placebo. The final survival data also showed a statistically significant survival benefit in the group of patients with Gleason scores of seven and less. The study's principal investigators plan to submit the complete survival data from this trial for presentation at an upcoming scientific meeting and for publication in a peer reviewed medical journal. In the D9901 study, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days. Provenge is being further evaluated in an ongoing, pivotal Phase 3 trial (D9902B) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Provenge also has Fast Track designation. The double-blind, placebo-controlled trial is enrolling patients at leading cancer centers around the country. To learn more about the trial, go to www.dendreon.com.

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