CHICAGO — Roche recently announced results from a Phase III study of bevacizumab that showed women with previously untreated advanced ovarian cancer who received bevacizumab in combination with chemotherapy, followed by the continuation of bevacizumab 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.
A safety assessment noted adverse events consistent with those observed in pivotal trials of bevacizumab.
The study, known as GOG 0218, was conducted by a network of researchers led by the Gynecologic Oncology Group.
The results of the study were featured in a press briefing at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO).
The full results were presented at the ASCO plenary session by Dr. Robert Burger, the GOG 0218 study chairman and director of the Women’s Cancer Center at Fox Chase Cancer Center.
“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 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) bevacizumab in combination with chemotherapy (paclitaxel and carboplatin), and continued use of bevacizumab 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 ratio = 0.72, p=<0.0001, a 28 percent reduction in the risk of cancer progression or death, which corresponds to a 39 percent improvement in the likelihood of living longer without the disease worsening).
The study also investigated bevacizumab in combination with chemotherapy but without the continuation of bevacizumab alone. Women who received this shorter duration of bevacizumab did not have a statistically significant increase in PFS compared with chemotherapy alone.
“We are encouraged by these results as there have been few improvements in outcomes for women with this disease in the past decade. Bevacizumab in combination with chemotherapy, followed by the continued use of bevacizumab, helped women with advanced ovarian cancer live longer without their disease worsening,” said Dr. Hal Barron, head of global development and chief medical officer for Roche.
“We will discuss these data and next steps with US and global regulatory authorities,” Barron said.
The Gynecologic Oncology Group is a non-profit organization of more than 300 member institutions 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 the clinical trial development, execution, analysis and distribution of results. Continuous evaluation of the GOG’s processes is utilized in order to constantly improve the quality of patient care.