Published on Thursday, September 26, 2013
NovaRx Corp. (San Diego, Calif.) said Lucanix belagenpumatucel-L plus best supportive care (BSC) as maintenance therapy missed the primary endpoint of improving median overall survival (OS) vs. placebo plus BSC in the Phase III STOP trial to treat advanced non-small cell lung cancer (NSCLC) (20.3 vs. 17.8 months, p=0.594). The double-blind, international trial enrolled 532 patients with stage III/IV NSCLC who have responded to, or have stable disease following one regimen of, first-line platinum-based chemotherapy. NovaRx said the endpoint was not met due to enrollment of patients more than 12 weeks following the completion of chemotherapy. In a predefined subgroup of 305 patients who were enrolled within 12 weeks of completing chemotherapy, Lucanix led to a median OS of 20.7 months vs. 13.4 months for placebo (p=0.083). Data will be presented at the European Cancer Congress in Amsterdam on Sept. 28.
NovaRx Corp. (San Diego, Calif.) said Lucanix belagenpumatucel-L plus best supportive care (BSC) as maintenance therapy missed the primary endpoint of improving median overall survival (OS) vs. placebo plus BSC in the Phase III STOP trial to treat advanced non-small cell lung cancer (NSCLC) (20.3 vs. 17.8 months, p=0.594). The double-blind, international trial enrolled 532 patients with stage III/IV NSCLC who have responded to, or have stable disease following one regimen of, first-line platinum-based chemotherapy. NovaRx said the endpoint was not met due to enrollment of patients more than 12 weeks following the completion of chemotherapy. In a predefined subgroup of 305 patients who were enrolled within 12 weeks of completing chemotherapy, Lucanix led to a median OS of 20.7 months vs. 13.4 months for placebo (p=0.083). Data will be presented at the European Cancer Congress in Amsterdam on Sept. 28.
belagenpumatucel-L as a rocket-science medicine:
A transforming growth factor beta2 (TGF-beta2) antisense gene-modified allogeneic tumor cell vaccine with potential immunostimulatory and antineoplastic activities. Belagenpumatucel-L is prepared by transfecting allogeneic non-small cell lung cancer (NSCLC) cells with a plasmid containing a TGF-beta2 antisense transgene, expanding the cells, and then irradiating and freezing them. Upon administration, this agent may elicit a cytotoxic T lymphocyte (CTL) response against host NSCLC cells, resulting in decreased tumor cell proliferation; vaccine immunogenicity may be potentiated by suppression of tumor TGF-beta2 production by antisense RNA expressed by the vaccine plasmid TGF-beta2 antisense transgene. Elevated levels of TGF-beta2 are frequently linked to immunosuppression in cancer patients and may be inversely correlated with prognosis in patients with NSCLC
A transforming growth factor beta2 (TGF-beta2) antisense gene-modified allogeneic tumor cell vaccine with potential immunostimulatory and antineoplastic activities. Belagenpumatucel-L is prepared by transfecting allogeneic non-small cell lung cancer (NSCLC) cells with a plasmid containing a TGF-beta2 antisense transgene, expanding the cells, and then irradiating and freezing them. Upon administration, this agent may elicit a cytotoxic T lymphocyte (CTL) response against host NSCLC cells, resulting in decreased tumor cell proliferation; vaccine immunogenicity may be potentiated by suppression of tumor TGF-beta2 production by antisense RNA expressed by the vaccine plasmid TGF-beta2 antisense transgene. Elevated levels of TGF-beta2 are frequently linked to immunosuppression in cancer patients and may be inversely correlated with prognosis in patients with NSCLC
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