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Genentech (RHHBY): Third Phase III Study of Avastin-Based Regimen Met Primary Endpoint in Ovarian Cancer


2/8/2011 7:21:02 AM

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that OCEANS, a Phase III study evaluating Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone until disease progression in women with previously treated (recurrent), platinum-sensitive ovarian cancer, met its primary endpoint.

The study showed that women who received a combination of Avastin and chemotherapy, followed by the continued use of Avastin alone, lived longer without their disease worsening (progression-free survival or PFS), compared to women who received chemotherapy alone. No new safety findings were observed and adverse events were consistent with those seen in previous pivotal trials of Avastin. Full data from the OCEANS study will be submitted for presentation at an upcoming medical meeting.

“We are very pleased with the results of the OCEANS study, as women with ovarian cancer need new treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “Avastin has now demonstrated a significant improvement in PFS in ovarian cancer in three large Phase III studies, and we look forward to sharing the data at an upcoming medical meeting.”

The results from this trial build on findings from two previous Phase III studies (GOG 0218 and ICON7) in women with newly diagnosed ovarian cancer. Both of these studies demonstrated that front-line Avastin in combination with standard chemotherapy (carboplatin and paclitaxel), followed by the continued use of Avastin alone, significantly increased the time women with ovarian cancer lived without their disease getting worse, compared to those treated with chemotherapy alone. Roche has submitted a European Union marketing authorization application for the use of Avastin in the front-line setting based on the results from GOG 0218 and ICON7 and expects a decision from the Committee for Medicinal Products for Human Use (CHMP) later this year. Genentech plans to submit applications in the United States for the use of Avastin in ovarian cancer in 2011.

About the OCEANS Study

OCEANS is a multicenter, randomized, double-blind, placebo-controlled Phase III study in 484 women with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancer. Women in OCEANS had received no more than one treatment regimen prior to enrollment in the trial. The trial was designed to evaluate Avastin (15 mg/kg every three weeks) in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin as a single agent until disease progression, compared to placebo in combination with carboplatin and gemcitabine chemotherapy followed by placebo alone. The primary endpoint of the study was PFS. The secondary endpoints of the study included overall survival, objective response, duration of response and safety.

The time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-sensitive’ disease if disease recurrence occurred more than six months after completing their initial platinum-based chemotherapy, and ‘platinum-resistant’ disease if recurrence occurred within six months.

About Previous Phase III Studies of Avastin in Ovarian Cancer

The GOG 0218 Study

Results from the GOG 0218 study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma who already had surgery showed that women who received Avastin (15 mg/kg) in combination with chemotherapy (paclitaxel and carboplatin), and continued use of Avastin alone for a total duration of 15 months, had a median PFS of 14.1 months compared to 10.3 months in women who received chemotherapy alone (hazard ratio=0.72, p<0.0001). This is a 39 percent improvement in the likelihood of living longer without the disease worsening, which corresponds to a 28 percent reduction in the risk of cancer progression or death.

The GOG 0218 study protocol allowed for different ways to determine if a patient’s disease had progressed. Disease progression was measured using both levels of a protein (CA-125) and 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 18.2 months compared to 12.0 months in women who received chemotherapy alone, increasing the likelihood of them living longer without the disease worsening by 56 percent (based on a hazard ratio=0.64, p<0.0001), which corresponds to a 36 percent reduction in the risk of cancer progression or death.

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

The ICON7 Study

In a second Phase III international study in 1,528 women with previously untreated epithelial ovarian, primary peritoneal or fallopian tube carcinoma, women who received Avastin (7.5 mg/kg) in combination with chemotherapy (paclitaxel and carboplatin), and continued use of Avastin alone for a total duration of up to 12 months, had a median PFS of 18.3 months compared to 16 months in women who received chemotherapy alone (hazard ratio=0.79, p=0.001). This is a 27 percent improvement in the likelihood of living longer without the disease worsening which corresponds to a 21 percent reduction in the risk of cancer progression or death. Adverse events were consistent with those observed in pivotal trials of Avastin.

About Ovarian Cancer

According to the American Cancer Society, in 2010 an estimated 21,880 women were diagnosed with ovarian cancer in the U.S. and approximately 13,850 died from the disease. Of the 21,880 women projected to be diagnosed with ovarian cancer in 2010, about 80 percent, or 17,504 women, were diagnosed with an advanced stage of the disease. The disease causes more deaths than any other gynecologic cancer and the American Cancer Society estimates that nearly 70 percent of women with advanced disease will die from it within five years.

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumor growth and spread. Studies have shown a correlation between a high concentration of VEGF and ascites development (excess fluid in the body cavity), disease worsening, and a poorer prognosis in women with ovarian cancer.

About Avastin

Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.

Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.

BOXED WARNINGS and Additional Important Safety Information

People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (0.3 percent to 2.4 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.

Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with advanced colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin.

Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that requires medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.

Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people.

Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.

Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin.

Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother.

First-line Metastatic Colorectal Cancer

In the first-line mCRC trial, the most common severe to life-threatening side effects that increased by two percent or more in people who received Avastin plus IFL (chemotherapy) vs. IFL alone were weakness (10 percent vs. 7 percent), abdominal pain (8 percent vs. 5 percent), pain (8 percent vs. 5 percent), high blood pressure (12 percent vs. 2 percent), blood clots in the veins of the body (9 percent vs. 5 percent), blood clots inside the abdomen (3 percent vs. 1 percent), a brief loss of consciousness (3 percent vs. 1 percent), diarrhea (34 percent vs. 25 percent), constipation (4 percent vs. 2 percent), reduced white blood cell counts (37 percent vs. 31 percent), and reduced white blood cell counts that may increase the chance of infection (21 percent vs. 14 percent).

Second-line Metastatic Colorectal Cancer

In the second-line mCRC trial, the most common severe to life-threatening and fatal side effects that increased by two percent or more in people who received Avastin plus FOLFOX4 (chemotherapy) vs. FOLFOX4 alone were diarrhea (18 percent vs. 13 percent), nausea (12 percent vs. 5 percent), vomiting (11 percent vs. 4 percent), dehydration (10 percent vs. 5 percent), blockage of the bowel (4 percent vs. 1 percent), numbness and tingling in fingers and toes (17 percent vs. 9 percent), nervous system disturbances (5 percent vs. 3 percent), tiredness (19 percent vs. 13 percent), abdominal pain (8 percent vs. 5 percent), headache (3 percent vs. 0 percent), high blood pressure (9 percent vs. 2 percent), and severe bleeding (5 percent vs. 1 percent).

Non-small Cell Lung Cancer

In the NSCLC trial, the most common life-threatening to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group were reduced white blood cell counts (27 percent vs. 17 percent), tiredness (16 percent vs. 13 percent), high blood pressure (8 percent vs. 0.7 percent), infection without reduced white blood cell counts (7 percent vs. 3 percent), blood clots in the veins of the body (5 percent vs. 3 percent), fever with reduced white blood cell counts (5 percent vs. 2 percent), inflammation of the lungs (5 percent vs. 3 percent), infection with severe or life-threatening reduced white blood cell counts (4 percent vs. 2 percent), low sodium levels in the blood that could lead to seizure or coma (4 percent vs. 1 percent), headache (3 percent vs. 1 percent), and too much protein in the urine (3 percent vs. 0 percent).

Metastatic Kidney Cancer

In the metastatic kidney cancer trial, the most common severe to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group included tiredness (13 percent vs. 8 percent), weakness (10 percent vs. 7 percent), too much protein in the urine (7 percent vs. 0 percent), high blood pressure (6 percent vs. 1 percent), and severe bleeding (3 percent vs. 0.3 percent).

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contact:

Genentech Krysta Pellegrino, 650-467-6800 (Media) Sonali Padhi, 650-467-0842 (Advocacy) Karl Mahler, 011 41 61 687 8503 (Investor Relations) Thomas Kudsk Larsen, 973-235-3655 (Investor Relations)


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