Roche announced that a phase-III study showed the combination of Avastin (bevacizumab) and chemotherapy followed by maintenance use of Avastin increased the time women with advanced ovarian cancer lived without their disease worsening (progression-free survival or PFS) compared to chemotherapy alone. A preliminary assessment of safety noted adverse events previously observed in pivotal trials with Avastin. Data from the study will be submitted for presentation at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
This is the first positive phase-III study of an anti-angiogenic therapy in advanced ovarian cancer and continues to support Avastin and anti-angiogenesis as a fundamental pillar of cancer treatment. Advanced ovarian cancer is a disease where outlook for patients remains poor and new effective therapies are needed. Avastin has shown the potential to provide this new therapy option for physicians and to bring hope to patients and their families.
In the three-arm study, known as Gynecologic Oncology Group (GOG) 0218, women with newly diagnosed advanced ovarian cancer who already had surgery to remove as much of the tumour as possible were randomised to receive one of the following:
Arm 1: Placebo in combination with commonly-used chemotherapy followed by placebo for a total treatment duration of up to 15 months. Arm 2: Avastin in combination with commonly-used chemotherapy followed by placebo for a total treatment duration of up to 15 months. Arm 3: Avastin in combination with commonly-used chemotherapy followed by the continuation of Avastin alone, as maintenance therapy, for a total treatment duration of up to 15 months The study showed that women who continued maintenance use of Avastin alone, after receiving Avastin in combination with chemotherapy (Arm 3), lived longer without the disease worsening compared to those who received chemotherapy alone. Women who received Avastin in combination with chemotherapy, but did not continue maintenance use of Avastin alone (Arm 2), did not live longer without the disease worsening compared to chemotherapy alone.
“We are greatly encouraged by these results which suggest that Avastin could offer women with advanced ovarian cancer more time without their disease worsening,” said Pascal Soriot, COO of Roche’s Pharmaceutical Division. “Women with this disease still have a poor outlook and we are committed to working with the relevant health authorities to make Avastin available to these patients.”