OncoGenex (OGXI) Publishes Data from Custirsen in Advanced NSCLC
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OncoGenex Pharmaceuticals, Inc. (Nasdaq: OGXI) announced today that data evaluating its investigational compound custirsen (OGX-011/TV-1011) in patients with advanced non-small cell lung cancer (NSCLC) were published in an early online version of the January 2012 issue of the Journal of Thoracic Oncology. These data provide additional clinical evidence for the potential of custirsen, a drug designed to block production of clusterin, a cell survival protein that is commonly overexpressed in several cancer types.
The single-arm trial, conducted at 15 sites in North America, evaluated treatment of custirsen in combination with a gemcitabine/platinum-based regimen in patients with previously untreated, advanced NSCLC. Eighty-one patients received at least one dose of custirsen and were included in the primary analysis. Key study findings are as follows:
The single-arm trial, conducted at 15 sites in North America, evaluated treatment of custirsen in combination with a gemcitabine/platinum-based regimen in patients with previously untreated, advanced NSCLC. Eighty-one patients received at least one dose of custirsen and were included in the primary analysis. Key study findings are as follows:
- The median overall survival was 14.1 months and progression-free survival was 4.3 months.
- The one- and two-year survival rates were 54% and 30%, respectively; twelve percent of patients were still alive at a median follow-up of 41 months (range 38-59 months).
- 69% of patients had a clinical response defined as objective response or stable disease and 31% of patients had tumor responses defined as complete or partial responses.
- Custirsen treatment decreased serum clusterin levels in 95% of patients evaluated. In addition, patients who achieved a threshold minimum serum clusterin level of < / = 45 mcg/mL had a median survival of 27.1 months compared to 15.6 months for patients who did not.
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