Roche (RHHBY) recently announced positive results on oncology drug Avastin from a phase III study, GOG240 (n=452).
Results showed that Avastin, when added to chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan), improved overall survival of women suffering from advanced cervical cancer.
Roche observed a 29% reduction in the risk of death for women who received Avastin plus chemotherapy vis-à-vis those who received only chemotherapy.
Additionally, Roche announced final results from a randomized, double-blind, placebo controlled phase III trial, AVAglio, on Avastin.
The study was conducted to evaluate the efficacy and safety profile of Avastin in combination with radiotherapy and Temodar (temozolomide) after a surgery or biopsy in recently diagnosed glioblastoma patients.
The results from the AVAglio study showed that patients on Avastin plus radiotherapy and Temodar experienced major improvement in progression-free survival (PFS) vis-à-vis those who received placebo plus radiotherapy and Temodar.
However, there was no significant improvement in overall survival.
Roche observed a 36% reduction in risk of glioblastoma worsening or death in patients who received Avastin plus radiotherapy and Temodar as compared to those who were only treated with radiotherapy and Temodar plus placebo.
We note that Avastin is approved in the US as a monotherapy for treatment-experienced adults suffering from glioblastoma.
It is also approved in combination with intravenous 5FU-based chemotherapy for treating patients suffering from metastatic colorectal cancer and in combination with carboplatin and paclitaxel for the first-line treatment of advanced non-squamous, non-small cell lung cancer.
Avastin was one of the leading drugs for Roche with 6% year over year sales growth in 2012. We note that in Nov 2011, the FDA had announced the cancellation of Avastin’s approval for breast cancer based on the conclusion that the drug was not found to be safe and effective for that indication.
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