Hormonresistenter Prostatakrebs

[renegat]

Hallo Mitbetroffene,

bin heute durch Zufall auf folgende Meldung gestoßen
www.gpc-biotech.de
Ist jemandem die Firma bzw. das Präparat "Satraplatin" bereits bekannt?
Bitte um Ihre Meinung.

mfg renegat

[Carola-Elke]

Hallo Renegat,

ja, hier wurde einmal ansatzweise drüber diskutiert, denn ich hatte auch darüber gelesen und mich gefragt, warum es bislang in Bezug auf PK kaum erwähnt wurde.

http://forum.prostatakrebs-bps.de/showthread.php?p=2242#post2242

Viele Grüsse,

Carola-Elke

[Günter Feick]

Hallo Renegat,

weiter unten ist ein Text vom heutigen Tag aus den Medical News Today zur abgeschlossenen Phase III Studie - Satraplatin und Prednison vs. Placebo und Prednison. Die Marktzulassung für Europa wird beantragt im kommenden Jahr. Habe im Moment keine Zeit für die Übersetzung.

Günter Feick

Pharmion Corporation and GPC Biotech Announce Positive Results from the Satraplatin Pivotal Phase 3 Trial and Achievement of the Progression-Free Survival Endpoint

40% Reduction in Risk of Disease Progression Seen with Satraplatin Compared to Control

Highly Statistically Significant Results Seen for Progression-Free Survival (p<0.00001)
Regulatory Submission Expected by Year-End 2006, European Filing in H1 2007BOULDER, Colo., MARTINSRIED/MUNICH, Germany, WALTHAM, Mass. and PRINCETON, N.J.,

Sept. 24 Pharmion Corporation (Nasdaq: PHRM) and GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced positive topline results for the double-blinded, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The trial is evaluating satraplatin plus prednisone versus placebo plus prednisone as a second-line treatment in 950 patients with hormone-refractory prostate cancer (HRPC).

The study data show that the results for progression-free survival (PFS) are highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the U.S and will also serve as the primary basis for a Marketing Authorization Application (MAA) in EuropeUsing the protocol-specified hazard ratio, which measured the overall risk of disease progression, patients in the SPARC trial who received satraplatin plus prednisone had a 40% reduction in the risk of disease progression (hazard ratio of 0.6; 95% Confidence Interval: 0.5-0.7) compared with patients who received prednisone plus placebo. The improvement seen in progression-free survival by patients treated with satraplatin increased over time. Progression-free survival at the median (50th percentile) demonstrated a 13% improvement in patients who received satraplatin plus prednisone (11 weeks) compared to patients who received prednisone plus placebo (9.7 weeks). Progression-free survival at the 75th percentile showed an 89% improvement for patients in the satraplatin arm (36 weeks) versus patients in the placebo arm (19 weeks). At 6 months, 30% of patients in the satraplatin arm had not progressed, compared to 17% of patients in the control arm. At 12 months, 16% of patients who received satraplatin had not progressed, compared to 7% of patients in the control arm. All of these analyses were conducted on an intent-to-treat basis.

The improvement in PFS in the satraplatin arm was not affected by the type of prior chemotherapy; in particular, the improvement was seen equally for patients who had received prior Taxotere(R) (docetaxel), as well as those who received other types of chemotherapy treatments. All disease progression events were adjudicated by an independent expert review committee of medical oncologists and radiologists. The vast majority of progression events were based on radiological progressions and pain progressions.In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed will continue to be treated, and all patients will be followed for overall survival. With approximately half of the patients from the trial still alive, the companies currently expect to have final overall survival results in the fall of 2007, rather than the previously communicated mid-2007

As anticipated, the most common adverse reactions consisted of myelosuppression (bone marrow functions, such as lowered platelet count or lowered white blood cell count) and gastrointestinal events, such as nausea, vomiting and diarrhea. These adverse reactions were mostly mild to moderate in severity.

Patients with advanced hormone-refractory prostate cancer are in urgent need of new treatment options. We are excited about the highly statistically significant improvement in progression-free survival demonstrated by satraplatin in our Phase 3 registrational trial. Importantly, the difference in progression-free survival increases over time in favor of the satraplatin group," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. "Based on the positive data announced today, we will move forward as rapidly as possible with the FDA with the goal of completing the filing for marketing approval of satraplatin in the U.S before the end of this year. We believe that these results demonstrate the benefits that satraplatin can provide men with advanced prostate cancer. In addition, the oral administration of satraplatin offers the patient the convenience of outpatient therapy and the potential for greater dosing coordination with other cancer therapies," said Patrick J. Mahaffy, President and Chief Executive Officer of Pharmion Corporation. "Pharmion remains focused on preparing its marketing authorization application, which we plan to file with the European regulatory authorities in the first half of 2007. We have worked closely with GPC Biotech since licensing the European and other international rights to satraplatin last December and look forward to continuing our partnership as we move through the regulatory process towards commercialization.

The SPARC trial is a double-blinded, randomized, placebo-controlled multinational Phase 3 trial assessing satraplatin plus prednisone as a second- line chemotherapy treatment for patients with HRPC. A total of 950 patients were accrued to the trial at more than 200 clinical sites in fifteen countries on four continents. The companies plan to submit data from the SPARC trial for presentation at an upcoming major medical conference.

Biotech intends to move forward with the U.S. Food and Drug Administration (FDA) with the goal of completing the submission of the rolling New Drug Application (NDA) by the end of 2006 for approval to market satraplatin. Pharmion Corporation intends to file an MAA to the European Medicines Agency (EMEA) in the first half of 2007

[JosefJ]

Hallo Renegat,

hallo Elke,
hallo Günther,



Die vorläufigen Studienergebnisse von Satraplatin schauen nicht schlecht aus. In Kürze:


a) Die Verlängerung des progressionsfreien Überlebens in der jetzt veröffentlichten Phase III Saatrahplatinstudie wurde durch die vorangegangene Taxoterechemo nicht wesentlich beeinflusst, wenn man die Daten mit der vorangegangenen Phase II vergleicht. Offensichtlich waren keine Kreuzresistenzen o.ä. zu sehen. Wichtig für diejenigen von uns, die bereits eine Taxoterechemo hinter sich haben.
b) Es wurde im Mittel eine 40%ige Verlängerung der PFS-Zeit (progressionsfreies Überleben) gemessen. Verständlicher ausgedrückt: für diejenigen, die länger in der Studie behandelt wurden, konnte das progressionsfreie Überleben um fast 4 Monate gesteigert werden gegenüber jenen, die nur Prednisone u. Placebo erhielten.
c) Eine Untergruppe von 30% der HRPC Patienten waren auch nach 6 Monaten noch progressionsfrei.
d) Eine noch kleinere Untergruppe von 17% waren selbst nach 12 Monaten noch progressionsfrei.
e) Auch die OS-Daten (der tatsächliche Gewinn an Lebenszeit) scheinen sehr ermutigend zu werden. Allerdings läuft da die Studie noch.

Insgesamt bin ich selber überrascht, wie positiv die Daten sind. Ich hätte es Satraplatin so nicht zugetraut. Die Verabreichung ist viel einfacher als bei Taxotere. Die Patienten schluckten, ich glaube für 5 Tage im Monat täglich 80 mg Satraplatin als Tablette. Das Nebenwirkungsprofil ist für ein Platinderivat sehr günstig.


Also bald haben wir (ab 2007/2008 auch für Europa) neben Taxotere ein zweites wirksames Chemotherapeutikum. Es wird kein ganz großer Durchbruch in der Behandlung des hormonrefraktären Prostatakrebses sein, aber doch ein wichtiges zusätzliches Medikament, das in einer Phase, in der es bisher nicht mehr allzu viele Alternativen gab, neue Möglichkeiten der Behandlung eröffnet.


Wir können weiter hoffen!!!


Josef