Genentech's second Phase III ICON7 study of Avastin in ovarian cancer meets primary endpoint

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a second large, Phase III, international study showed that the combination of Avastin^® (bevacizumab) and chemotherapy, followed by the continued use of Avastin 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 Avastin across tumor types for approved indications. 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 Avastin in combination with chemotherapy followed by the continued use of Avastin alone helped women live longer without their disease getting worse," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "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."

The ICON7 study is sponsored by the Medical Research Council (MRC) in the United Kingdom (U.K.), led by the MRC Clinical Trials Unit and conducted through an international network of researchers in the Gynecologic Cancer InterGroup (GCIG). In the study, 1,528 women with newly diagnosed ovarian cancer who already had surgery were randomized to receive one of the following:

• Arm 1: Chemotherapy (carboplatin and paclitaxel) for 6 cycles
• Arm 2: Avastin (7.5mg/kg every three weeks) in combination with chemotherapy (carboplatin and paclitaxel) for 6 cycles followed by Avastin alone (for a total of 18 cycles, up to 12 months)

Another Phase III study of Avastin (known as GOG 0218) in women with previously untreated advanced ovarian cancer presented in June at the Annual Meeting of the American Society of Clinical Oncology (ASCO) also met its primary endpoint of PFS. The GOG 0218 study used an Avastin dose of 15mg/kg (every three weeks) in combination with carboplatin and paclitaxel, followed by the continued use of Avastin alone, for a total duration of up to 15 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 an Avastin dose of 7.5mg/kg (every three weeks) in combination with the same chemotherapy regimen, followed by the continued use of Avastin alone, for a total duration of up to 12 months.