Data from Satraplatin SPARC Phase 3 Trial in Patients with Hormone-Refractory Prostate Cancer Progressing after Initial Chemothe
02 June 2008 - 5:06PM
Business Wire
GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today
announced the presentation of the overall survival results from the
double-blind, randomized satraplatin Phase 3 registrational trial,
the SPARC trial (Satraplatin and Prednisone Against Refractory
Cancer). The data were presented at the 44th Annual Meeting of the
American Society for Clinical Oncology (ASCO) in Chicago. The SPARC
trial evaluated satraplatin plus prednisone versus placebo plus
prednisone in 950 patients with hormone-refractory prostate cancer
(HRPC) that had progressed after initial chemotherapy. While data
presented previously did show a statistically significant
improvement in the progression-free survival endpoint, the trial
did not achieve the endpoint of overall survival (p=0.80, log rank
analysis) for the intent-to-treat (ITT) population. The median was
61.3 weeks for the satraplatin arm compared to 61.4 weeks for the
control group, and the hazard ratio, stratified by the
pre-specified randomization factors1, was 0.98 (95% CI: 0.84,
1.15). The median in the patient group previously treated with
docetaxel (Taxotere�) was 66.1 weeks for the satraplatin arm
compared to 62.9 weeks for the control arm. The stratified hazard
ratio was 0.91 (95% CI: 0.72, 1.14). When adjusted for the three
pre-specified prognostic factors which showed statistically
significant imbalances between the two treatment arms (lactate
dehydrogenase, hemoglobin and alkaline phosphatase), the hazard
ratio for the ITT group was 0.88 (95% CI: 0.74, 1.03). Importantly,
when adjusted for the three significant prognostic factors, there
was a positive trend observed in those patients who had progressed
after receiving docetaxel, with a hazard ratio of 0.78 (95% CI:
0.61, 0.99). �There is a need for new therapies for patients with
hormone-refractory prostate cancer whose disease has progressed
after initial chemotherapy treatment,� said A. Oliver Sartor, M.D.,
Piltz Endowed Professor of Cancer Research and Professor of
Medicine and Urology, Tulane Medical School, and one of the
principal investigators of the SPARC trial. �While satraplatin did
not improve overall survival in the intent-to-treat population,
there was a positive trend observed in patients who progressed
after Taxotere treatment when adjusted for significant prognostic
factors. Additionally, I believe that satraplatin has been shown to
be a well tolerated treatment that has demonstrated an important
benefit for patients by showing a statistically significant
improvement in progression-free survival, as well as pain, tumor
and PSA response rates in the overall patient population.� Of note,
a significant number of patients received additional cancer
therapies after they progressed in the SPARC trial. In the control
arm, 68.6% of patients received some form of third-line therapy,
including chemotherapy, immunotherapy and other treatments, versus
61.7% of patients in the satraplatin arm. In the control arm, 52.4%
of patients received chemotherapy compared to 44.7% in the
satraplatin arm, and 24.4% of patients in the control arm were
treated with Taxotere following progression in the SPARC trial
compared to 18.3% in the satraplatin arm. Taxotere is considered
the standard of care in the first-line treatment of HRPC patients
in the United States and many countries in Europe. Safety findings
in the SPARC trial were consistent with previous clinical studies
involving satraplatin. Myelosuppression (decrease in the production
of blood cells by the bone marrow) was the most common adverse
reaction associated with satraplatin therapy, with 98.9% of
patients in the satraplatin arm experiencing myelosuppression of
any grade. A total of 22.6% of patients in the satraplatin arm
experienced grade 3 or 4 thrombocytopenia; 14.5% had grade 3 or 4
leucopenia; 22.3% had grade 3 or 4 neutropenia and 11.9%
experienced grade 3 or 4 anemia. Gastrointestinal toxicities of any
grade were the most frequent non-hematological adverse events
(occurring in 59.5% of the patients receiving satraplatin). A total
of 7.8% of patients in the satraplatin arm experienced grade 3 or 4
gastrointestinal toxicities, including nausea (1.4%), vomiting
(1.6%), diarrhea (1.9%) and constipation (1.9%). Additionally, 5%
or less of patients in the satraplatin arm experienced grade 3 or 4
fatigue (1.9%), grade 3 or 4 infections (4.3%) and
pulmonary/respiratory grade 3 or 4 toxicities (3.3%). About
Satraplatin Satraplatin, an investigational drug, is a member of
the platinum family of compounds. Platinum-based drugs are a
critical part of modern chemotherapy treatments and are used to
treat a wide variety of cancers. All platinum drugs currently on
the market require intravenous administration. Satraplatin is an
oral compound that clinical trial patients are able to take at
home. A Marketing Authorization Application for satraplatin in
combination with prednisone is currently under review in Europe for
the treatment of hormone-refractory prostate cancer patients whose
prior chemotherapy has failed. A decision on the filing by the
European regulators is expected in the second half of 2008. Celgene
Corporation is responsible for the regulatory filings for
satraplatin and its development and commercialization for Europe
and certain other territories. GPC Biotech also has a license
agreement with Yakult Honsha Co. Ltd. under which Yakult has
exclusive commercialization rights to satraplatin for Japan and is
taking the lead in developing the drug in that territory. GPC
Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc.
in 2002. About GPC Biotech GPC Biotech AG is a publicly traded
biopharmaceutical company focused on anticancer drugs. GPC
Biotech's lead product candidate is satraplatin, an oral platinum
compound. The Company has various anti-cancer programs in research
and development that leverage its expertise in kinase inhibitors.
GPC Biotech AG is headquartered in Martinsried/Munich (Germany) and
has a wholly owned U.S. subsidiary in Princeton, New Jersey. For
additional information, please visit GPC Biotech's Web site at
www.gpc-biotech.com. This press release contains forward-looking
statements, which express the current beliefs and expectations of
the management of GPC Biotech, including statements about the
efficacy and safety of satraplatin. Such statements are based on
current expectations and are subject to risks and uncertainties,
many of which are beyond our control, that could cause future
results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by
such forward-looking statements. Actual results could differ
materially depending on a number of factors, and we caution
investors not to place undue reliance on the forward-looking
statements contained in this press release. Satraplatin may not be
approved for marketing in a timely manner, if at all. We direct you
to GPC Biotech�s Annual Report on Form 20-F for the fiscal year
ended December 31, 2006 and other reports filed with the U.S.
Securities and Exchange Commission for additional details on the
important factors that may affect the future results, performance
and achievements of GPC Biotech. Forward-looking statements speak
only as of the date on which they are made and GPC Biotech
undertakes no obligation to update these forward-looking
statements, even if new information becomes available in the
future. Satraplatin has not been approved by the FDA in the U.S.,
the EMEA in Europe or any other regulatory authority and no
conclusions can or should be drawn regarding its safety or
effectiveness. Only the relevant regulatory authorities can
determine whether satraplatin is safe and effective for the use(s)
being investigated. Taxotere� is a registered trademark of Aventis
Pharma S.A. 1 The three pre-specified randomization factors for the
SPARC trial were: 1) performance status at study entry, 2) present
pain intensity at study entry, and 3) type of disease progression
on first line therapy (PSA or symptomatic).
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