After yesterday's news regarding the negative data for bevacizumab (Avastin) in gastric cancer, I wasn't expecting to hear any more from Roche this week, however, the opposite happened and this morning positive data was sitting waiting for me in my inbox today!
Well, results from phase III study demonstrated the combination of bevacizumab and chemotherapy followed by maintenance use of bevacizumab increased the time women with advanced ovarian cancer lived without their disease worsening as measured by progression-free survival (PFS) compared to chemotherapy alone. Advanced ovarian cancer generally has a poor prognosis, so new therapy options are much needed.
Roche's press release declared that:
"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 today."
What does the data show?
The Gynecologic Oncology Group (GOG) completed a three-arm trial in 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:
- Placebo in combination with commonly-used chemotherapy (ie carboplatin (AUC 6 IV) and paclitaxel (175mg/m2) for 6 cycles), followed by placebo for a total treatment duration of up to 15 months.
- Bevacizumab (5mg/kg for 5 cycles starting at cycle 2) in combination with carboplatin and paclitaxel (6 cycles), followed by placebo for a total treatment duration of up to 15 months.
- Bevacizumab in combination with carboplatin and paclitaxel, followed by the continuation of bevacizumab alone as maintenance therapy, for a total treatment duration of up to 15 months.
Overall, the trial showed that women who continued maintenance use of bevacizumab alone, after receiving bevacizumab in combination with chemotherapy (Arm 3), lived longer without the disease worsening compared to those who received chemotherapy alone. Women who received bevacizumab in combination with chemotherapy, but did not continue maintenance therapy with bevacizumab (Arm 2), did not live longer without the disease worsening compared to chemotherapy alone.
The full results will be presented at ASCO in June.
Meanwhile this is an interesting development in ovarian cancer, given that J&J have a filing for trabectedin (Yondelis) with the FDA for the same disease, although ODAC expressed concerns about the risk-benefit profile given the side effects associated with the chemotherapy.
Time will tell what will happen later this year but at the moment it's looking more promising for Roche/Genentech than J&J.