Genentech reports results from Phase III study of Avastin in women with advanced ovarian cancer

Genentech, Inc., a wholly owned member of the Roche Group, (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a Phase III study of Avastin® (bevacizumab) that showed women with previously untreated advanced ovarian cancer who received Avastin in combination with chemotherapy, followed by the continuation of Avastin alone, had a 39 percent improvement in the likelihood of living longer without the disease worsening (progression-free survival or PFS) compared to chemotherapy alone. An assessment of safety noted adverse events consistent with those observed in pivotal trials of Avastin. The study (known as GOG 0218), was conducted by a network of researchers led by the Gynecologic Oncology Group (GOG).

“Ovarian cancer is a difficult-to-treat disease with high morbidity and mortality, and there have been limited advances in treatment in the past decade”

These results were featured in a press briefing today at the 46th Annual Meeting of the American Society of Clinical Oncology. Full results will be presented at the ASCO plenary session by Dr. Robert Burger, M.D., the GOG 0218 Study Chair and Director of the Women's Cancer Center at Fox Chase Cancer Center (Abstract LBA001, Sunday June 6, 1:45 p.m. CDT).

"Ovarian cancer is a difficult-to-treat disease with high morbidity and mortality, and there have been limited advances in treatment in the past decade," said Dr. Burger. "These results may represent an important step forward for women who need more options."

GOG 0218 demonstrated that women with advanced ovarian cancer who received front-line (first-line following surgery) Avastin in combination with chemotherapy (paclitaxel and carboplatin), and continued use of Avastin alone for a total duration of up to 15 months, had a median PFS of 14.1 months compared to 10.3 months in women who received chemotherapy alone (hazard>

"We are encouraged by these results as there have been few improvements in outcomes for women with this disease in the past decade. Avastin in combination with chemotherapy, followed by the continued use of Avastin, helped women with advanced ovarian cancer live longer without their disease worsening," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer. "We will discuss these data and next steps with U.S. and global regulatory authorities."

Adverse events (observed between cycle two and 30 days after last treatment) that occurred at a higher frequency in patients who received Avastin in combination with chemotherapy, followed by the continuation of Avastin alone, compared to patients who received chemotherapy alone, were neutropenia (low white blood cell count; Grade 4 or higher; 63.3 percent vs. 57.7 percent), pain (Grade 3 or higher; 13.7 percent vs. 9.2 percent) and hypertension (high blood pressure; Grade 3 or higher; 10.4 percent vs. 1.7 percent). Gastrointestinal (GI) events (Grade 2 or higher) including perforation (a hole in the stomach, small intestine, or large intestine), fistula (an abnormal passage from one part of the body to another), necrosis (bowel tissue dying) and leak occurred in 2.6 percent vs. 1.2 percent.

Additional efficacy analysis

The GOG 0218 study protocol allowed for different ways to determine if a patient's disease had progressed (worsened). Disease progression could be measured based exclusively on levels of a protein (CA-125) in the blood, or through the use of CA-125 levels and evidence of progression by a radiograph/scan. (CA-125 is measured by a blood test and is sometimes used to demonstrate a response to chemotherapy or to diagnose a recurrence or progression of ovarian cancer.)

An analysis of efficacy was conducted for regulatory purposes that only included disease progressions determined by radiographs/scans (excluding progressions based on CA-125 alone). In this analysis, women who continued Avastin, following Avastin in combination with chemotherapy, had a median PFS of 18.0 months compared to 12.0 months in women who received chemotherapy alone, increasing the likelihood of them living longer without the disease worsening by 54 percent.

SOURCE Genentech, Inc.