Saturn Clinical Trial
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Phase 2 survival results in the
Journal of Clinical Oncology
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Phase 2 Results with First-line Chemotherapy

Custirsen Phase 2 clinical trial in patients with CRPC receiving custirsen and docetaxel as first-line chemotherapy

Final results of a randomized Phase 2 trial evaluating the benefit of combining custirsen with first-line docetaxel in patients with CRPC were published in the September 2010 issue of the Journal of Clinical Oncology (2010;28:4247-54). In this Phase 2 trial, patients were randomized to receive either docetaxel by itself, or custirsen plus docetaxel.

The trial enrolled 82 patients at 12 sites in Canada and the United States from September 2005 to December 2006. Patients were randomized to one of two treatment arms to receive either 640 mg of custirsen per week by intravenous infusion in combination with docetaxel and prednisone or docetaxel and prednisone alone.

Patients in both treatment arms received therapy until disease progression, toxicity, or the completion of 10 3-week cycles of therapy. Analyses indicated a survival benefit in patients treated with custirsen in combination with docetaxel compared to docetaxel alone, which is the current standard of care for first-line chemotherapy treatment of patients with advanced prostate cancer.

  • The median overall survival in patients who were treated in the custirsen plus docetaxel arm was 23.8 months compared with 16.9 months for patients treated with docetaxel alone, indicating a 6.9-month survival advantage in the custirsen arm.
  • The unadjusted HR was 0.61, representing a 39% lower rate of death for patients treated with custirsen.
  • A prospectively defined multivariate analysis indicated that the significant predictors of overall survival were treatment arm, performance status, and presence of metastases other than in bone or lymph nodes. In the multivariate analysis, patients treated with custirsen had a rate of death 51% lower than patients treated with docetaxel alone (HR=0.49; P=0.012). Additional exploratory analyses found that the lower rate of death was associated with the effect of custirsen treatment even when varying amounts of chemotherapy were administered.

    In other words, there was a lower rate of death in patients who received custirsen when compared with the control arm for patients receiving six or fewer cycles of chemotherapy, as well as for patients receiving 10 cycles of chemotherapy.

Safety

  • Custirsen has been administered to 294 patients with various types of cancer in Phase 1 and Phase 2 clinical trials. Most patients experienced one or more adverse events, some of which were attributable to either the disease itself or other treatments in the protocol. Most adverse events were mild, and those commonly associated with custirsen consisted of flu-like symptoms. A total of 74 patients (25%) developed serious adverse events (SAEs). For 36 patients (12%), the events were considered by the Investigator to be possibly, probably or definitely related to study treatment (chemotherapy plus custirsen). The most common serious adverse events associated with custirsen were febrile neutropenia, pyrexia, pleural effusion, and dyspnea.

Disclaimer: Custirsen (OGX-011) is not approved for commercial use in the United States or in countries outside of the United States. Custirsen is an investigational new drug that is being studied for the treatment of prostate cancer in clinical trials.

Taxotere® and Jevtana® are registered trademarks of Sanofi-aventis.

Taxotere® and Jevtana® are registered trademarks of Sanofi-aventis.

Taxotere® is a registered trademark of Sanofi-aventis.

Tylenol® #3 with codeine is a registered trademark of McNeil Consumer Healthcare.

*Most prostate cancer initially responds to various therapies, but eventually becomes resistant and often spreads to other parts of the body.

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