Ovarian cancer trial boost for Avastin
pharmafile | July 5, 2010 | News story | Research and Development | Roche, avastin, ovarian cancer
Roche’s blockbuster oncology drug Avastin has met its primary endpoint of improving progression-free survival in women with ovarian cancer in a phase III trial.
Avastin met its primary endpoint of progression-free survival (PFS) as assessed by trial investigators. Secondary endpoints of the study included overall survival, response rate, duration of response, quality of life and safety.
The ICON7 trial was an international, multi-centre, randomised, open-label, phase III study in 1,528 women with previously untreated epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
The trial evaluated Avastin plus standard of care chemotherapy (carboplatin and paclitaxel) followed by the continued use of Avastin alone, compared to chemotherapy alone.
Currently, treatment options for women with the disease are limited to surgery and chemotherapy.
Hal Barron, executive vice-president global development and chief medical officer for Roche, said: “With few advances in ovarian cancer and a need to improve outcomes for women with this disease, it is encouraging that a second phase III study showed that Avastin in combination with chemotherapy followed by the continued use of Avastin alone helped women live longer without their disease getting worse.”
Barron added: “ICON7 is part of our continued commitment to understand the full potential of Avastin in ovarian cancer which includes several phase III studies in combination with other agents and in various stages of the disease.”
ICON7 was sponsored by the Medical Research Council (MRC) in the UK, led by the MRC Clinical Trials Unit and conducted through an international network of researchers in the Gynaecologic Cancer InterGroup (GCIG)
It is the second phase III trial for this indication, with results from the first being published at the American ASCO oncology conference in June.
Avastin is currently licensed for colorectal, breast, kidney, brain and non-small cell lung cancers making Roche CHF 6.2 billion in sales last year.
It has not always been smooth sailing for the oncology giant with the drug failing a phase III study in February for a severe form of stomach cancer.
Ben Adams
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