Roche has unveiled results from a late-stage study which show its cancer blockbuster Avastin helped people with newly-diagnosed glioblastoma live longer, although the co-endpoint of overall survival was not met.
Data from the Phase III AVAglio study have been presented at the Society for Neuro-Oncology meeting in Washington DC, which show Avastin (bevacizumab) in combination with radiation and temozolomide chemotherapy reduced the risk of cancer worsening or death (progression-free survival) by 36% compared to radiation and temozolomide plus placebo in people with newly-diagnosed glioblastoma. The latter is the most common and aggressive form of primary brain cancer.
Specifically, Roche noted that a 4.4 month improvement in median PFS was observed compared to those who received radiation and chemotherapy plus placebo (10.6 months vs 6.2 months). No new safety findings were observed in the study and adverse events were consistent with those seen in previous trials of Avastin for approved indications.
However, the interim results for overall survival, the other co-primary endpoint, did not reach statistical significance, Roche noted. Final OS data are expected next year but by meeting its co-primary endpoint of PFS, Roche noted that AVAglio is the first positive Phase III study in newly-diagnosed glioblastoma since 2005.
Roche chief medical officer Hal Barron noted that people with newly diagnosed glioblastoma "have few treatment options and need new medicines”. He added that an important outcome from the AVAglio study was that patients who received Avastin plus radiation and chemotherapy "lived significantly longer without their disease getting worse and we plan to discuss these data with regulatory authorities".
Avastin is already approved in the USA and almost 40 other countries for the treatment of glioblastoma as a single agent and in some countries in combination with irinotecan for adults with progressive disease following prior therapy.
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