Avastin bevacizumab: Phase III data

Data from the 2-year, U.S. Phase III CATT trial in 1,185 patients with neovascular AMD showed that intravitreal Avastin was non-inferior to Lucentis ranibizumab on the primary endpoint of mean change from baseline in visual acuity at 1 year when the drugs were administered on either a monthly schedule or on an as needed basis. Specifically, patients receiving monthly Avastin or monthly Lucentis gained 8 and 8.5 letters, respectively, on the ETDRS eye chart from baseline to 1 year, while patients receiving Avastin as needed or Lucentis as needed gained 5.9 and 6.8 letters, respectively. Lucentis administered as needed was also equivalent to monthly Avastin, while the comparison between Avastin as needed and monthly Lucentis was inconclusive. The non-inferiority limit for the difference between treatment groups at 1 year was 5 letters.

Additionally, there were no significant differences between treatment groups in the proportion of patients whose visual acuity improved by >=15 letters from baseline to 1 year on the ETDRS eye chart (31.3 % for monthly Avastin vs. 34.2% for monthly Lucentis; and 28% for Avastin as needed vs. 24.9% for Lucentis as needed). Rates of death, myocardial infarction (MI) and stroke were also similar between treatment groups (p>0.2). The proportion of patients with serious systemic adverse events, primarily hospitalizations, was significantly higher for Avastin vs. Lucentis (24.1% vs. 19%, p=0.04). The average cost of a study drug for the first year was $23,400 for monthly Lucentis vs. $595 for monthly Avastin, and $13,800 for Lucentis as needed vs. $385 for Avastin as needed. Data were published in the New England Journal of Medicine. Analysts expect data from CATT to be presented at the Association for Research in Vision and Ophthalmology meeting this week in Fort Lauderdale. The CATT study is sponsored by NIH's National Eye Institute. Roche's Genentech Inc. unit said in a statement that the data "add to an emerging body of evidence from much larger analyses that suggest the risk of systemic adverse events may be higher when injecting Avastin into a person's eye compared to Lucentis." ...