Avastin Needs Quality Of Life Data In Confirmatory Glioblastoma Trial – Cmte.
Executive Summary
Quality of life issues could be incorporated into a Phase III confirmatory study for Genentech's Avastin in treatment of glioblastoma multiforme, following suggestions by members of FDA's Oncologic Drugs Advisory Committee
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Quality of life issues could be incorporated into a Phase III confirmatory study for Genentech's Avastin in treatment of glioblastoma multiforme, following suggestions by members of FDA's Oncologic Drugs Advisory Committee. The clinical benefit from Avastin (bevacizumab) in GBM is likely to be in an improvement in quality of life, rather than survival, Acting Chair Wyndham Wilson, National Cancer Institute, suggested. "One would hope that a confirmatory trial would in a prospective manner have that built in." ODAC voted 10-0 in support of accelerated approval of an sBLA for the indication March 31, primarily because of its therapeutic impact on edema (see 1 (Also see "Avastin Clinical Benefit Trumps Anti-Tumor Effect In Glioblastoma, ODAC Says" - Pink Sheet, 6 Apr, 2009.)). FDA and Genentech have agreed to a Phase III clinical trial with overall survival and progression-free survival as co-primary endpoints. To be conducted by Roche, the trial will collect data on Avastin used in combination with radiation and temozolomide in patients with newly diagnosed glioblastoma. Although the trial design is still being finalized, the study has a planned enrollment of 920 and is expected to be completed in 2014. While the co-primary endpoints are "very valid," David Harrington, Dana-Farber Cancer Institute, noted, "I don't think that progression-free survival is quite the same thing as the apparent symptom relief that we're all seeing and hearing about." "We would hope that in 2014 you won't ... say 'we didn't get a significant p-value for survival but we have reduced edema. We have people who have great stories about being able to return to their life," Harrington said. The study will measure neurocognitive function as secondary endpoints, "but they are currently not powered to the degree that I think would satisfy the committee," Genentech Senior Vice President for Clinical Hematology and Oncology David Schenkein noted. - Cathy Dombrowski ([email protected]) |