IRVINE, Calif., June 4 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced the presentation of additional data from the double-blind, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The data are being presented today at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago. The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. A New Drug Application (NDA) for satraplatin is currently under priority review by the U.S. Food and Drug Administration (FDA).
“Today hormone-refractory prostate cancer patients whose chemotherapy has failed have no approved treatment options. The data I have presented today from the SPARC trial show that satraplatin lowers the risk of disease progression by 33 percent compared to control. The data are consistent across numerous pre-defined subsets, including patients previously treated with Taxotere,” said Cora Sternberg, M.D., FACP, Chief of the Department of Medical Oncology at the San Camillo and Forlanini Hospitals, Rome, Italy and one of the principal investigators of the SPARC registrational trial. “I believe these efficacy results, together with satraplatin’s manageable side effect profile, mean that, if approved, satraplatin will represent an important new therapy option for patients with advanced prostate cancer whose prior chemotherapy has failed.”
“These data are consistent with our expectations for satraplatin as a second-line treatment for hormone refractory prostate cancer and demonstrate the value of satraplatin to men suffering from this deadly disease,” stated Luigi Lenaz, M.D., Chief Scientific Officer of Spectrum Pharmaceuticals. “Based on the full data set, we look forward to the ODAC panel meeting in July.”
The relative risk of disease progression favored satraplatin for all pre-specified patient subsets, including prior Taxotere use, geographies, and the presence or absence of pain. For each of the 20 subsets presented today, the reduction in relative risk of disease progression ranged from 26 percent to 46 percent, corresponding to hazard ratios between 0.74 and 0.54.
Disease progression in the SPARC trial was defined as the first occurrence of any of several types of progression, including radiologic tumor progression (RECIST for soft tissue lesions or two or more new lesions on a bone scan); skeletal-related events (including a bone fracture, bone surgery or initiation of bisphosphonates); symptomatic progression (pain, weight loss, worsening of performance status); or death from any cause. Approximately 37 percent of patients in the trial progressed by pain and approximately 36 percent progressed on radiologic evidence. The hazard ratio for PFS for the subset of patients with pain progression or death was 0.64 (95 percent CI: 0.51-0.79, p=0.0001), representing a 36 percent reduction in the relative risk of progression. The hazard ratio for PFS for the subset of patients with radiologic progression or death was 0.64 (95 percent CI: 0.51-0.81, p=0.0001), representing a 36 percent reduction in the relative risk of progression. The hazard ratio for PFS for the subset of patients who progressed in ways other than radiologic or pain progression was 0.86 (95 percent CI: 0.63-1.17, p > 0.05).
In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.
As previously communicated, the interim analysis for overall survival conducted in June 2006 showed a trend, although not statistically significant, in favor of the satraplatin arm.
PFS data as observed by the clinical site investigators were also presented today. Compared to the PFS data previously reported, these progression events were not adjudicated by the blinded independent review committee. The hazard ratio for PFS for the intent-to-treat population per investigator observation was 0.58 (95 percent CI: 0.50-0.67, p = 0.000000000002). Median time to progression was 16.0 weeks for the satraplatin arm versus 6.0 weeks for control. The hazard ratio for PFS for the intent-to-treat population treated with prior Taxotere(R) (docetaxel) per investigator observation was 0.52 (95 percent CI: 0.42-0.65, p=0.000000002), with a median time to progression of 15.3 weeks for the satraplatin arm compared to 5.6 weeks for control. These data are consistent with the PFS outcomes as adjudicated by the blinded independent review committee.
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. Twenty-one percent of patients in the satraplatin arm experienced grade 3 or 4 thrombocytopenia; 14 percent had grade 3 or 4 leucopenia and 21 percent had grade 3 or 4 neutropenia. Gastrointestinal disorders were the most frequent non-hematological adverse events (occurring in 57.9 percent of the patients receiving satraplatin). Eight percent of patients in the satraplatin arm experienced grade 3 or 4 gastrointestinal toxicities, including nausea (1.3 percent), vomiting (1.6 percent), diarrhea (2.1 percent) and constipation (2.1 percent). Additionally, 5 percent or less of patients in the satraplatin arm experienced grade 3 or 4 fatigue (1.7 percent), grade 3 or 4 infections (4.0 percent) and pulmonary/respiratory grade 3 or 4 toxicities (3.0 percent).
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. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority and no conclusions can or should be drawn regarding its safety and efficacy.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer whose prior chemotherapy has failed. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. In accordance with the recommendation of the independent Data Monitoring Board for the SPARC trial, patients who have not progressed continue to be treated and all patients will be followed for overall survival.
In addition to hormone refractory prostate cancer, satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned.
In 2002, Spectrum licensed the global rights to GPC Biotech . GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories.
Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. Spectrum’s expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and risk-reduced methods of commercialization. The company’s pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at http://www.spectrumpharm.com.
Forward-looking statement - This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum’s ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company’s promising pipeline, our team’s ability to identify promising drugs and move these drugs through development and toward commercialization, the safety and efficacy of satraplatin, the value of satraplatin to men suffering from hormone refractory prostate cancer, that satraplatin will represent an important new therapy option for patients with advanced prostate cancer whose prior chemotherapy has failed, that Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer chemotherapy and in a number of cancer types are underway or planned and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. We do not plan to update any such forward- looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath SVP & Chief Business Officer Porter Novelli Life Sciences 619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
Spectrum Pharmaceuticals
CONTACT: Russell Skibsted, SVP & Chief Business Officer, or Paul Arndt,Manager of Investor Relations, +1-949-788-6700, both of SpectrumPharmaceuticals; Susan Neath of Porter Novelli Life Sciences,+1-619-849-6007, for Spectrum Pharmaceuticals
Web site: http://www.spectrumpharm.com/
