Clinical Data
Results from a Phase 2b study of Stimuvax® in non-small cell lung cancer have been promising. In this study, 171 patients were randomized to receive either Stimuvax plus best standard of care or best standard of care alone. Study endpoints were safety and survival with quality of life and immune response as secondary endpoints. Thirteen sites in Canada and four in the United Kingdom participated in the trial. The median survival for that subset of patients with Stage IIIB NSCLC (locoregional disease) was 30.6 months for patients treated with Stimuvax plus best standard of care versus 13.3 months for the patients treated with best standard of care alone.
Clinical data relating to long-term treatment with Stimuvax were presented at the International Association for the Study of Lung Cancer's 13th World Conference on Lung Cancer in San Francisco on August 1, 2009. The presentation by Dr. Glenwood Goss from the Ottawa Hospital Cancer Centre, Ottawa, Ontario, involved 16 patients who received treatment with Stimuvax for between 2 and 8.2 years as part of the Phase 2b trial in patients with stage IIIb/IV non-small cell lung cancer (NSCLC).
As of the time of data analysis in April 2009, 10 of the 16 studied patients were alive without evidence of disease progression, of whom eight continued to receive therapy with Stimuvax after 6.3 to 8.2 years. The remaining two living patients discontinued Stimuvax therapy after 2.4 and 5.8 years, respectively, and were without evidence of disease progression. Nine of the 10 living patients had stage IIIb NSCLC upon entry to the trial, while one had stage IV disease. Six of the 10 living patients had a complete response to their first-line chemotherapy or chemo-radiation, while four patients had stable disease. The remaining six of the 16 patients discontinued Stimuvax after 2.0 to 5.1 years of treatment as a result of disease progression and are deceased.
Prolonged treatment with Stimuvax was well-tolerated in this trial. The most common treatment-related adverse events were injection-site reactions, which tended to diminish after the first year of treatment. There was no evidence of autoimmune reactions with prolonged use.
An additional comparability trial of Stimuvax was conducted. Results from this two-year Phase 1/2 multicenter study of Stimuvax in patients (n=22) with unresectable stage III non-small cell lung cancer were presented at the American Society of Clinical Oncology Annual Meeting in June 2008. Results demonstrated that after a median follow-up period of 26.7 months, the two-year overall survival rate was 64 percent (95 percent confidence interval, 44-84 percent). No new safety concerns were identified in the study.
Phase 2b Study - Randomized Trial of
Stimuvax in NSCLC -- Median Survival Advantage from Stimuvax: 17.3 months
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