Basel, 07 December 2016
Roche’s Avastin (bevacizumab) plus chemotherapy receives FDA approval for platinum-sensitive recurrent ovarian cancer
- Approval based on two large Phase III studies including GOG-0213 that showed a five month overall survival difference for women with platinum-sensitive recurrent ovarian cancer on Avastin plus chemotherapy compared to chemotherapy alone
- In the United States, Avastin is now approved for nine distinct uses across six different types of cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy.
“With today’s approval of Avastin plus chemotherapy, women in the U.S. with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than five months compared to chemotherapy alone in a clinical trial,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “This approval was based in part on a Gynecologic Oncology Group cooperative clinical trial and reinforces the importance of partnerships with study groups to identify new treatment options for people in need.”
Avastin in combination with chemotherapy for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer was granted priority review, and today’s approval is based on results from two randomised, controlled Phase III studies, GOG-0213 and OCEANS. The GOG-213 study demonstrated that adding Avastin to chemotherapy showed an overall survival difference of five months compared to chemotherapy alone (median OS: 42.6 months vs. 37.3 months; Hazard Ratio (HR)=0.84, 95% CI: 0.69-1.01 and HR=0.82, 95% CI: 0.68-0.996, depending on stratification factor*). Both the GOG-0213 and OCEANS studies demonstrated a significant improvement in the time women lived without their disease getting worse (progression-free survival, PFS). The GOG-0213 study showed that women lived a median of 3.4 months longer without disease progression with the addition of Avastin to chemotherapy compared to chemotherapy alone (median PFS: 13.8 months vs. 10.4 months; HR=0.61, 95% CI: 0.51-0.72). The OCEANS study showed that Avastin in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (median PFS: 12.4 months vs. 8.4 months; HR=0.46, 95% CI: 0.37-0.58; p<0.0001). Overall survival, one of the secondary endpoints in the OCEANS study, was not significantly improved with the addition of Avastin to chemotherapy (HR=0.95, 95% CI: 0.77-1.17). Adverse events in both studies were consistent with other Phase III studies of Avastin.
(*refer to details under GOG-0213 data table)
In November 2014, Avastin was approved in the United States for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy. Women are considered to have a ‘platinum-resistant’ form of the disease if a relapse occurs less than six months after the last treatment with a platinum-based chemotherapy.
About the GOG-0213 and OCEANS studies
GOG-0213 is an independent Phase III study sponsored by the National Cancer Institute (NCI) and conducted by the Gynecologic Oncology Group (GOG) that enrolled 673 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The primary endpoint of the study was to assess whether the addition of Avastin to chemotherapy (carboplatin and paclitaxel) followed by continued use of Avastin alone increased overall survival (OS) compared to chemotherapy alone. Progression-free survival (PFS) and objective response rate (ORR) were secondary endpoints in the GOG-0213 study.
1. Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of treatment free-interval prior to enrolling onto this study per IVRS (interactive voice response system) and secondary surgical debulking status.
2. Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status.
OCEANS, a company sponsored trial, is a placebo-controlled, randomised, multicentre Phase III study that evaluated the safety and efficacy of Avastin, administered in combination with chemotherapy (carboplatin and gemcitabine), in 484 women with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The primary endpoint of the study was PFS, as determined by the investigator using Response Evaluation Criteria for Solid Tumors (RECIST). Secondary endpoints included ORR, OS and safety.
About ovarian cancer
Ovarian cancer causes more deaths than any other gynaecologic cancer in the United States. In 2016, about 22,200 women will be diagnosed with ovarian cancer in the United States and about 14,200 will die from the disease. Patients are said to have ‘platinum-sensitive’ disease if a relapse occurs six months or longer following the last cycle of platinum-based chemotherapy. About half of those who relapse after initial treatment – over 8,000 women – will have platinum-sensitive ovarian cancer.
With the initial approval in the United States for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer, ovarian cancer and cervical cancer, and is available in the United States for the treatment of colorectal cancer, non-small cell lung cancer, kidney cancer, cervical cancer and recurrent, platinum-resistant and platinum-sensitive ovarian cancer. In addition, Avastin is approved over 70 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal cancer, non-small cell lung cancer, breast cancer, ovarian cancer and malignant glioma, including newly diagnosed glioblastoma.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over two million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 300 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.
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