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New Data from Satraplatin Phase 3 Trial in Second-Line Castrate-Refractory Prostate Cancer Presented at 2009 ASCO Annual Meeting

  • SPARC Trial Analyses Demonstrate Pain At Baseline, Pain Progression And Progression-Free Survival At Three Months Are Predictive Of Overall Survival In Metastatic Castrate-Refractory Prostate Cancer Patients Previously Treated With Docetaxel
  • Data From Several Other Trials Evaluating Satraplatin In Combination With Various Anti-Cancer Therapies Published In ASCO Proceedings

IRVINE, Calif.--(BUSINESS WIRE)--Jun 2, 2009 - Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with two proprietary, FDA-approved oncology drugs on the market, today announced that data from the double-blind, randomized satraplatin Phase 3 trial, the SPARC trial (Satraplatin and Prednisone Against Refractory Cancer) were presented at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. The SPARC trial evaluated satraplatin plus prednisone versus placebo plus prednisone in 950 patients with castrate-refractory prostate cancer (CRPC) who had progressed after initial chemotherapy. The data presented are retrospective analyses of the SPARC trial evaluating correlations between overall survival (OS) and pain at baseline, pain progression, and progression-free survival (PFS) at three months.

One presentation (“Use of pain at baseline and pain progression to predict overall survival in patients with docetaxel pretreated metastatic castration-refractory prostate cancer: results from the SPARC trial,” Sartor et al, Abstract #5148), analyzed the docetaxel-pretreated population (n= 488) in two separate ways:

 

  • The first analysis compared OS in those patients who had no pain* (Present Pain Intensity (PPI) score < 1) vs. those with pain (PPI > 2) at time of entry to the trial; and
  • The second analysis compared OS in those patients who experienced pain progression versus progression by pre-specified measures other than pain (as judged by the blinded Independent Review Committee (IRC)).

Shorter OS time was observed in docetaxel-pretreated patients who had pain at baseline compared to those who did not. The median survival of patients with baseline pain (n=178) was 44 weeks versus 72 weeks for patients without baseline pain (n=287) [stratified hazard ratio: 0.59 (95% CI: 0.48-0.74), stratified log-rank p<0.0001]. The IRC found that 414 docetaxel-pretreated patients (84.8%) progressed as of the data cutoff date for the SPARC study. Of these, the median survival of patients showing pain progression (n=196) was 47 weeks, compared to 71 weeks for non-pain progressors (n=292) [stratified hazard ratio: 0.71 (95% CI: 0.57-0.87), stratified log-rank p=0.0022]. Thus, pain at baseline, as well as pain progression, were prognostic indicators of OS in the docetaxel-pretreated patient population.

A second presentation (“Correlation of progression-free survival and overall survival in men with metastatic castration-resistant prostate cancer who failed first-line chemotherapy: results from the SPARC trial,” Halabi et al, Abstract #5150) evaluated whether PFS at three months was predictive of OS and explored the statistical dependencies between PFS and OS. Of the 853 men alive at three months post-randomization, 477 (56%) had already progressed. The median survival for this group was 34.5 weeks versus 78.7 weeks in men who had not progressed at the same three month timepoint. [hazard ratio: 2.16 (95% CI =1.84-2.55), p-value <0.001]. The dependence between PFS and OS was 0.29 (95% confidence limits = 0.24-0.33, p-value < 0.00001). Thus PFS at three months predicts OS. Additional studies will be needed to assess the clinical relevance of the individual components of progression as defined in the SPARC trial to OS.

Data from other Phase I and Phase II clinical trials evaluating satraplatin in combination with other cancer therapeutic drugs were published in the 2009 ASCO Annual Meeting Proceedings.

 

  • Phase II trial of bevacizumab and oral satraplatin and prednisone in docetaxel pretreated metastatic castrate resistant prostate cancer – Vaishampayan et al (Abstract #e16028)
  • Dose finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors – Di Paola et al (Abstract #e13534)
  • A phase I study investigating the combination of orally bioavailable platinum and nonparticle albumin-bound paclitaxel in advanced solid tumors – Deshpande et al (Abstract #e13501)

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. Spectrum licensed worldwide rights to satraplatin from Johnson Matthey PLC. In 2002, Spectrum licensed such rights to satraplatin to GPC Biotech AG. GPC Biotech is responsible for all costs associated with the development and regulatory filings of satraplatin. GPC Biotech has a license agreement with Yakult Honsha Co., Ltd., under which Yakult has exclusive commercialization rights to satraplatin for Japan.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a focus in oncology. The Company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy.

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 a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of satraplatin 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.

SPECTRUM PHARMACEUTICALS, INC. ® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

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Posted: June 2009

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