Avid Bioservices Inc (CDMO)

[freethemice]

Avastin did extend PFS, but not OS, in newly diagnosed glioblastoma. This is the same situation as in metastatic breast cancer.
The PFS result is not a predictor of OS result.

Chicago -- June 1, 2013 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced final results from the Phase III AVAglio study in people with newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer. Final results confirmed people who received Avastin® (bevacizumab) plus radiotherapy and temozolomide chemotherapy benefited from a significant improvement in progression-free survival (PFS) compared to those who received placebo plus radiotherapy and temozolomide chemotherapy. Overall survival (OS) was not significantly improved in the study.

As previously announced, Avastin plus radiotherapy and temozolomide chemotherapy significantly reduced the risk of the glioblastoma worsening or death by 36 percent compared to radiotherapy and temozolomide chemotherapy plus placebo (PFS as assessed by trial investigators, a co-primary endpoint: HR=0.64; p<0.0001, median PFS 10.6 months vs. 6.2 months, respectively). People who received Avastin plus radiotherapy and temozolomide chemotherapy did not have a statistically significant improvement in OS (the other co-primary endpoint), compared to those who received radiotherapy and temozolomide chemotherapy plus placebo (HR=0.88; [95% CI 0.76, 1.02], p=0.0987). Median survival was similar in both arms (16.8 months vs. 16.7 months, respectively). No new safety findings were observed in the AVAglio study and adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications.

http://www.gene.com/media/press-releases/14447/2013-06-01/genentech-announces-final-phase-iii-stud