Roche drug helps women with ovarian cancer live longer

BASEL, Switzerland — Roche announced recently that a second large, phase III, international study showed that the combination of bevacizumab and chemotherapy followed by the continued use of bevacizumab alone, increased the time women with previously untreated ovarian cancer lived without the disease worsening (progression-free survival or PFS, the primary endpoint), compared to chemotherapy alone.

Adverse events were consistent with those observed in pivotal trials of bevacizumab.

Data from the study, known as ICON7, will be submitted for presentation at an upcoming medical meeting.

“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 bevacizumab in combination with chemotherapy followed by the continued use of bevacizumab alone helped women live longer without their disease getting worse,” said Dr. Hal Barron, Roche executive vice president for global development and chief medical officer.

“ICON7 is part of our continued commitment to understand the full potential of bevacizumab in ovarian cancer which includes several phase III studies in combination with other agents and in various stages of the disease,” Barron said.

The ICON7 study is sponsored by the Medical Research Council (MRC) in the United Kingdom, led by the MRC Clinical Trials Unit and conducted through an international network of researchers in the Gynaecologic Cancer InterGroup (GCIG).

In the study, 1,528 women with newly diagnosed ovarian cancer who had already had surgery were randomized to receive one of the following:

• ARM 1: Chemotherapy (carboplatin and paclitaxel) for six cycles.

• ARM 2: Bevacizumab (7.5mg/kg every three weeks) in combination with chemotherapy (carboplatin and paclitaxel) for six cycles followed by bevacizumab alone (for a total of 18 cycles, up to 12 months).

In ICON7, the majority of patients had advanced stage ovarian cancer. However, the trial also included patients with earlier stage disease.

The ICON7 study used a bevacizumab dose of 7.5mg/kg (every three weeks) in combination with the same chemotherapy regimen, followed by the continued use of bevacizumab alone for a total duration of up to 12 months.