Brief description of Avastin success from SSB:
This afternoon, the NIH (National Institutes of Health) announced the positive outcome of a large clinical study of Avastin in advanced lung cancer known as ECOG 4599 earlier than anticipated. Genentech's stock was up nearly 25%
(+$10.92) in reaction to this news. The study was designed to assess Avastin in combination with standard chemotherapy (i.e., carboplatin/paclitaxel) as a first-line treatment in advanced non-small cell lung cancer (NSCLC) with a primary end point of overall survival. Since patient enrollment was completed in early 2004 and the study was event-driven basedon the number of deaths, the results were anticipated in either late Q2 or in the second half of 2005 assuming the comparative control arm achieved a median overall survival level of 8-11 months. Specifically, the results from a recent interim analysis, which led to this announcement, indicate an overall survival benefit in patients receiving Avastin in combination with standard chemotherapy. Patients in this arm of the study achieved a median overall survival of 12.5 months
compared to 10.2 months in patients receiving standard chemotherapy alone. This difference of 2.3 months is statistically significant and led the NIH to
release these top-line results earlier than expected since the study had met the primary endpoint. This early release of the data will allow presentation of the detailed results in time for the annual American Society of Clinical
Oncology (ASCO) annual meeting to be held in Orlando, Florida, on May 13-17, 2005. In our opinion, the opportunity for Avastin as a front-line therapy in
advanced lung cancer represents an additional $1+ billion market. This reinforces our belief that Avastin may represent a multi-billion dollar opportunity.
I would think there are strong competitive implications since ECOG 4599 had similar design to Stellar 3 but was able to demonstrate significant survival benefit. I am no biomaven however, so would appreciate any comments/criticisms, in order to get a better understanding. Might Avastin success even hurt Xyotax's chances for approval?
Sam |
