Genentech's Medicine Avastin Plus Chemotherapy Improved Survival in Women with Advanced Cervical Cancer, Compared to Chemotherapy Alone
-- First Phase III Study of Avastin in This Difficult-to-Treat Cancer --
CHICAGO--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the results of a large, independent study (GOG240) sponsored by the National Cancer Institute (NCI) and conducted by the Gynecologic Oncology Group (GOG), which showed that the addition of Avastin® (bevacizumab) to chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) extended the lives of women with advanced cervical cancer, compared to chemotherapy alone. The study met its primary endpoint of improving overall survival (OS) with a statistically significant 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (HR=0.71, p=0.0035).
Women who received Avastin plus chemotherapy lived a median of 3.7 months longer compared to those who received chemotherapy alone; the median OS was 17.0 months with Avastin plus chemotherapy compared to 13.3 months for chemotherapy alone. No new safety signals related to Avastin were observed and overall safety was consistent with that seen in previous pivotal studies of Avastin across different tumor types.
"Worldwide, cervical cancer is the third most common cancer in women, and those who have an advanced form of this cancer need new medicines," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We'd like to thank the GOG for their leadership and the NCI for their support of the study. We plan to discuss these encouraging data with regulatory authorities."
The GOG240 data will be presented today in the Plenary session of the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Krishnansu Sujata Tewari, University of California, Irvine Medical Center (Abstract 3, Sunday, June 2, 1:00 p.m. CDT).
GOG240 Study Results
Avastin in combination with chemotherapy reduced the risk of death by 29 percent compared to chemotherapy alone (HR=0.71, p=0.0035).
Median OS was 17.0 months for women who received Avastin plus chemotherapy compared to 13.3 months for chemotherapy alone.
Women who received Avastin plus chemotherapy experienced a 33 percent reduction in the risk of disease worsening or death (progression-free survival; PFS) compared to chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p<0.002).
Avastin plus chemotherapy shrank more tumors (response rate) than chemotherapy alone (48 percent vs. 36 percent, respectively, p=0.0078).
No new safety signals were observed and the overall safety was consistent with that seen in previous pivotal studies of Avastin across tumor types. The adverse events observed at a higher rate in patients treated with Avastin plus chemotherapy were gastrointestinal, thrombo-embolic, cardiac (hypertension) and hematologic (neutropenia and bleeding). There was no increase in treatment related deaths in the Avastin plus chemotherapy group as compared to the chemotherapy alone group.
About The GOG240 Study
GOG240 is an independent, NCI-sponsored Phase III trial assessing the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with advanced (Stage IVB) cervical cancer, or cervical cancer that persisted or recurred after standard treatment. The trial was supported by Roche. The primary endpoint of the study was OS. A total of 452 women in the United States and Spain were randomized to one of four treatment arms:
Paclitaxel and cisplatin.
Paclitaxel, cisplatin and Avastin (15 mg/kg every three weeks).
Paclitaxel and topotecan.
Paclitaxel, topotecan and Avastin (15 mg/kg every three weeks).
About the Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The Group is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of their processes is utilized in order to constantly improve the quality of patient care. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).
About Cervical Cancer
Cervical cancer is caused when cells of the cervix, the lower part of the uterus, become cancerous. According to the American Cancer Society, cervical cancer can often be found early and sometimes even prevented entirely by having regular Pap smears and human papilloma virus (HPV) tests. There is a dramatic difference in survival rates between early and advanced cervical cancer. When localized, at least eight out of 10 women will live for five years following diagnosis; when the disease is advanced (metastatic) then this drops to below one in seven women. It is estimated that more than 12,000 new cases of cervical cancer will be diagnosed in the United States in 2013 and about 4,000 women will die from the disease.
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 vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).
Avastin U.S. Indications:
Avastin is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. Avastin, in combination with fluropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.
Avastin is approved for first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer 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 (up 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 metastatic 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 require 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 2.6 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. Avastin can cause fertility issues for women. Avastin could cause a woman's ovaries to stop working and may impair her ability to have children.
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.
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.
For full Prescribing Information and Boxed WARNINGS on Avastin, please visit http://www.avastin.com.
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.
Holli Dickson, 650-922-1269
Sonali Padhi 650-467-0842
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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