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【drug-news】分析师对安进公司发布的抗前列腺癌
Amgen shares have soared after the firm presented impressive late-stage data which shows that the jewel in its portfolio, denosumab significantly improved bone metastasis-free survival in men with prostate cancer compared to placebo.
The US biotech has unveiled top-line results from a Phase III trial evaluating Xgeva (denosumab) versus placebo in 1,432 men with castrate-resistant prostate cancer (CRPC). The study showed that the drug significantly improved median bone metastasis-free survival by 4.2 months compared to placebo (the primary endpoint), and significantly improved time to first occurrence of bone metastases. Overall survival was similar between both arms.
Overall rates of adverse events and serious adverse events were generally similar between Xgeva and placebo, although hypocalcaemia and osteonecrosis of the jaw was observed at increased frequencies in the former arm.
Roger Perlmutter, head of R&D at Amgen, said the data demonstrate that Xgeva, a fully human monoclonal antibody designed to target RANK ligand, limits the ability of tumours to colonise bone, “an important finding for men at risk for bone metastases and their healthcare providers”. He added that “these landmark data” will be presented at an upcoming medical conference.
Analysts have reacted excitedly and Joshua Schimmer at Leerink & Co, said it was a positive result “for a study we did not think would succeed”. However he noted, as did other analysts, that the study did not show overall survival benefit, and Xgeva may have to demonstrate some other clear indication of benefit, such as time to skeletal-related events, if it is to get approval.
However, Baird & Co analyst Christopher Raymond argued that any focus on the lack of an overall survival benefit “misses the point that this drug will be used immediately in the CRPC setting as a preventive agent, and ignores tangible confounding factors that we think adequately explain this artifact”. Eric Schmidt at Cowen & Co was also impressed, claiming that approval in this indication and for breast cancer (trials began in June) could boost US sales of denosumab by as much as $4 billion a year,
Last month, the US Food and Drug Administration approved Xgeva for the prevention of skeletal-related events in patients with bone metastases from solid tumours, while denosumab, under the brandname Prolia, was approved by the FDA in May for postmenopausal women with osteoporosis who are at high risk for fractures.
http://www.pharmatimes.com/Article/10-12-15/Amgen_s_Xgeva_data_for_prostate_cancer_excites_analysts.aspx
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作者:admin@医学,生命科学 2010-12-24 21:45
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