Genentech reports positive results from Phase III AVAglio study

19th November 2012 (Last Updated November 19th, 2012 18:30)

Genentech has reported positive results from Phase III AVAglio study that assessed the efficacy and safety profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in glioblastoma patients.

genentech

Genentech has reported positive results from Phase III AVAglio study that assessed the efficacy and safety profile of Avastin in combination with radiation and temozolomide chemotherapy following surgery or biopsy in glioblastoma patients.

Avastin with radiation and temozolomide combination therapy minimised the worsening of cancer, progression-free survival (PFS), in newly diagnosed glioblastoma patients by 36% compared to radiation and temozolomide chemotherapy plus placebo, the co-primary endpoint of the study.

The other co-primary endpoint, interim results for overall survival failed to reach statistical significance.

Adverse events reported in the study were consistent with previous Avastin trials across tumour types for approved indications.

Genentech global product development head and chief medical officer Hal Barron said few treatment options are available for people with newly diagnosed glioblastoma and there is a need for new medicines.

"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," Barron added.

"Interim results for overall survival failed to reach statistical significance."

The placebo-controlled trial reported a 4.4 month improvement in median PFS in Avastin-combination with radiation and chemotherapy group, compared to radiation chemotherapy plus placebo group.

As assessed by an independent review committee PFS demonstrated a 39% reduction in the risk of disease worsening or death, which can also be referred to as a 64% improvement in PFS.

A 66% one-year survival rate was reported in the placebo arm against 72% in the Avastin arm while adverse events of special interest occurred in 28.7% of patients in the Avastin arm compared to 15.2% of patients in the radiation and chemotherapy plus placebo arm.


Image: Genentech Avastin helped people with newly diagnosed Glioblastoma live longer without disease worsening when added to radiation and chemotherapy. Photo: courteysd of Coolcaesar at Wikipedia.